Engineering

Syner-G BioPharma Group

Sr. Fill Finish Process Engineer (Future Opportunities)

**COMPANY DESCRIPTION:**

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video [**here**](<https://www.youtube.com/watch?v=2rUMvtncuw8>).

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit [www.Synergbiopharma.com](<https://www.synergbiopharma.com/>)

**POSITION OVERVIEW:**

We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MS\\&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.

We are actively seeking qualified candidates to join our talent pipeline for future client engagements.

**WORK LOCATION:**

Travel to client sites may be required up to 100% based on project phase and client needs.

**KEY RESPONSIBILITIES:**

(This list is not exhaustive and may be adjusted as needed.)

- Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.
- Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
- Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
- Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\\&IDs, and GMP requirements.
- Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
- Partner with Operations and MS\\&T to troubleshoot and resolve technical issues.
- Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
- Support continuous improvement and process optimization initiatives.
- Partner with QA, Validation, and MS\\&T to maintain validated state of aseptic manufacturing processes.
- Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
- Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
- Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.
- Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
- Develop and execute commissioning and qualification protocols.
- Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
- Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines
- Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.
- Participate in project planning, scheduling, risk assessments, and milestone tracking.
- Provide effective communication to stakeholders at all levels.

**QUALIFICATIONS AND REQUIREMENTS:**

*Education*

- Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.

*Experience*

- Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
- Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
- Experience supporting commercial manufacturing operations in a regulated environment.
- Experience with commissioning, qualification, and engineering documentation.

*Knowledge, Skills, and Abilities*

- Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment.
- Strong documentation and technical writing skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Strong communication, analytical, and problem-solving skills.
- Ability to work independently and collaboratively.

**ESSENTIAL FUNCTIONS:**

*Physical Demands*:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

*Work Environment*:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

**TOTAL REWARDS PROGRAM:**

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

**LEGAL STATEMENT:**

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

California

Reliability Engineer

**COMPANY DESCRIPTION:**

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video [**here**](<https://www.youtube.com/watch?v=2rUMvtncuw8>).

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit [www.Synergbiopharma.com](<https://www.synergbiopharma.com/>)

**POSITION OVERVIEW**

We are seeking a Reliability Engineer to support reliability, maintenance, and asset management activities within a regulated pharmaceutical or biotechnology manufacturing environment. The Reliability Engineer will work cross-functionally with Facilities, Engineering, Maintenance, Manufacturing, Quality, and other stakeholders to improve equipment reliability, optimize preventive maintenance strategies, reduce unplanned downtime, and support operational readiness.

The ideal candidate will have experience working with mechanical, electrical, process, or facility systems in GMP environments and a strong understanding of reliability engineering principles, maintenance best practices, and data-driven continuous improvement.

This position is internally classified as a Facilities Engineer and will have a primary focus on reliability engineering.

**WORK LOCATION**

Travel to client sites may be required up to 100%, depending on project demands and client expectations.

**KEY RESPONSIBILITIES**

(This list is not exhaustive and may be modified as needed.)

- Support reliability engineering activities for facility, utility, process, and manufacturing equipment in GMP and non-GMP environments.
- Develop, implement, and continuously improve preventive maintenance (PM) programs and asset maintenance strategies.
- Perform equipment and system criticality assessments to prioritize maintenance and reliability activities.
- Lead or support Root Cause Analysis (RCA), failure investigations, and failure mode assessments for equipment and system issues.
- Analyze equipment performance, maintenance history, downtime, and failure data to identify trends and improvement opportunities.
- Develop, maintain, and report reliability metrics and KPIs to measure equipment performance and identify potential failures or performance gaps.
- Support spare parts assessments, critical spare identification, inventory strategies, and risk mitigation planning.
- Recommend equipment life-extension strategies and reliability improvements for mechanical and electrical systems.
- Utilize Computerized Maintenance Management Systems (CMMS) to review equipment history, work orders, preventive maintenance activities, and asset data.
- Support operational readiness activities for new or modified equipment, systems, and facilities.
- Identify opportunities to improve equipment availability, maintainability, and overall asset performance.
- Apply Good Engineering Practices (GEP), reliability best practices, and maintenance best practices to engineering activities.
- Collaborate with Engineering, Facilities, Maintenance, Manufacturing, Quality, Validation, and other cross-functional stakeholders.
- Develop reports, presentations, and recommendations to communicate reliability performance and improvement initiatives.

**QUALIFICATIONS AND REQUIREMENTS**

*Education*

- Bachelor's degree in Chemical, Mechanical, Electrical, or another related Engineering discipline.

*Experience*

- Minimum of 1 year of relevant engineering experience.
- Experience within oral solid dose, biotechnology, pharmaceutical, R&D, or another highly regulated manufacturing environment preferred.
- Experience in Reliability Engineering, Facilities Engineering, Process Engineering, Plant Engineering, Maintenance Engineering, or a related discipline.
- Experience developing, implementing, or improving preventive maintenance programs and asset maintenance strategies.
- Experience with or knowledge of Computerized Maintenance Management Systems (CMMS).
- Experience analyzing maintenance and reliability data and developing metrics, KPIs, dashboards, or reports to support engineering decisions.

*Knowledge, Skills, and Abilities*

- Working knowledge of reliability engineering methodologies, including Root Cause Analysis (RCA), failure mode assessment, equipment criticality, and preventive maintenance optimization
- Knowledge of mechanical and electrical systems, equipment operation, common failure modes, and equipment life-extension strategies.
- Familiarity with spare parts assessments, equipment criticality reviews, and mitigation strategies designed to reduce unplanned downtime.
- Understanding of GMP requirements, Good Engineering Practices, and engineering expectations within regulated life sciences environments.
- Strong written and verbal communication skills with demonstrated ability to collaborate effectively with cross-functional teams and stakeholders.

*Preferred Experience*

- Experience supporting GMP manufacturing facilities, utilities, process equipment, or production systems.
- Experience with reliability-centered maintenance (RCM), FMEA/FMECA, predictive maintenance, or condition-based maintenance strategies.
- Experience supporting equipment commissioning, qualification, operational readiness, or maintenance program development for new or modified assets.
- Familiarity with CMMS platforms such as Maximo, Blue Mountain, SAP, or similar systems.
- Demonstrated ability to use reliability and maintenance data to identify performance gaps, reduce recurring failures, and improve asset availability.

**ESSENTIAL FUNCTIONS:**

*Physical Demands*:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

*Work Environment*:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

**TOTAL REWARDS PROGRAM:**

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

**LEGAL STATEMENT:**

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Massachusetts

**COMPANY DESCRIPTION:**

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video [**here**](<https://www.youtube.com/watch?v=2rUMvtncuw8>).

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit [www.Synergbiopharma.com](<https://www.synergbiopharma.com/>)

**POSITION OVERVIEW:**

We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MS\\&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.

**WORK LOCATION:**

Travel to client sites may be required up to 100% based on project phase and client needs.

**KEY RESPONSIBILITIES:**

(This list is not exhaustive and may be adjusted as needed.)

- Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.
- Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
- Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
- Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\\&IDs, and GMP requirements.
- Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
- Partner with Operations and MS\\&T to troubleshoot and resolve technical issues.
- Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
- Support continuous improvement and process optimization initiatives.
- Partner with QA, Validation, and MS\\&T to maintain validated state of aseptic manufacturing processes.
- Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
- Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
- Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.
- Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
- Develop and execute commissioning and qualification protocols.
- Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
- Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines
- Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.
- Participate in project planning, scheduling, risk assessments, and milestone tracking.
- Provide effective communication to stakeholders at all levels.

**QUALIFICATIONS AND REQUIREMENTS:**

*Education*

- Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.

*Experience*

- Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
- Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
- Experience supporting commercial manufacturing operations in a regulated environment.
- Experience with commissioning, qualification, and engineering documentation.

*Knowledge, Skills, and Abilities*

- Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment.
- Strong documentation and technical writing skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Strong communication, analytical, and problem-solving skills.
- Ability to work independently and collaboratively.

**ESSENTIAL FUNCTIONS:**

*Physical Demands*:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

*Work Environment*:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

**TOTAL REWARDS PROGRAM:**

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

**LEGAL STATEMENT:**

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Sr. Validation Engineer

**COMPANY DESCRIPTION:**

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video [**here**](<https://www.youtube.com/watch?v=2rUMvtncuw8>).

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit [www.Synergbiopharma.com](<https://www.synergbiopharma.com/>)

**POSITION OVERVIEW**

We are seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP‑regulated environments. This role is responsible for developing, executing, and managing validation lifecycle documentation while ensuring compliance with regulatory expectations and internal quality standards. The Sr. Validation Engineer will serve as a subject matter expert, support complex technical projects, and provide guidance to junior team members.

**KEY RESPONSIBILITIES**

(This list is not exhaustive and may be supplemented or adjusted as needed.)

- Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets.
- Oversee validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports.
- Write, review, and revise qualification and verification documents, including SOPs, validation master plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures.
- Prepare comprehensive summary reports for validation, verification, commissioning, and requalification activities.
- Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.
- Lead P&ID walkdowns to verify installation, configuration, and system readiness.
- Perform and oversee thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes.
- Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.
- Lead periodic reviews and requalification activities for temperature‑controlled systems and other validated assets.
- Provide technical mentorship and guidance to junior validation staff.
- Collaborate cross‑functionally to ensure validation activities align with project timelines and operational needs.

**QUALIFICATIONS AND REQUIREMENTS**

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

*Education*

- Bachelor’s degree in a life science, engineering, or related technical field.

*Technical Experience*

- 7–11 years of experience in the biotech, pharmaceutical, or medical device industry.
- Strong knowledge of FDA cGMP requirements, FMEA, and risk‑based validation principles.
- Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and process validation.
- Extensive experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation.
- Demonstrated experience writing and reviewing IQ, OQ, PQ, and CSV reports.
- Experience supporting audits, regulatory inspections, and remediation activities.

*Knowledge, Skills, and Abilities*

- Strong verbal and written communication skills, with the ability to explain complex technical concepts to diverse audiences.
- Highly organized with strong documentation and analytical skills.
- Ability to lead validation workstreams, manage multiple priorities, and work independently.
- Strong problem‑solving skills and experience supporting investigations and root‑cause analysis.
- Ability to mentor junior engineers and contribute to team development.

**ESSENTIAL FUNCTIONS:**

*Physical Demands*:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

*Work Environment*:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

**TOTAL REWARDS PROGRAM:**

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

**LEGAL STATEMENT:**

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

North Carolina

Validation Engineer

**COMPANY DESCRIPTION:**

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video [**here**](<https://www.youtube.com/watch?v=2rUMvtncuw8>).

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit [www.Synergbiopharma.com](<https://www.synergbiopharma.com/>)

**POSITION OVERVIEW:**

Syner-G is seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program.

**KEY RESPONSIBILITIES:**

(This list is not exhaustive and may be supplemented and changed as necessary.)

- Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification.
- Support validation activities for client projects, including generation, execution, review, and closure of validation life cycle documents
- Write, review, and revise Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
- Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
- Write procedures, investigations, protocols, reports, change controls, etc., to support the execution and closeout of validation work.
- Perform execution support activities including P&ID walkdowns, drawing reviews, and ETOP verification.
- Perform thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
- Support the resolution of regulatory observations or manufacturing site issues.
- Execute periodic reviews and requalification for temperature chambers.

**QUALIFICATIONS AND REQUIREMENTS**:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

*Education:*

- Bachelor’s degree in a related life science field.

*Technical Experience:*

- 3-10 years of experience within the biotech, pharmaceutical, or medical device industry.
- Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required.
- Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation.
- Hands-on equipment start-up and troubleshooting experience is highly desired.
- Report writing experience for IQ, OQ, PQ.

*Knowledge, Skills, and Abilities:*

- Strong verbal and written communication skills and the ability to discuss technical topics with stakeholders and non-technical people is strongly desired.

**ESSENTIAL FUNCTIONS:**

*Physical Demands*:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

*Work Environment*:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

**TOTAL REWARDS PROGRAM:**

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

**LEGAL STATEMENT:**

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Eli Lilly and Company

Principal SRE Engineer

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**About the technology organization**

Technology at Lilly builds and operates mission-critical digital products and platforms that support the discovery, development, and delivery of medicines that make life better for people around the world. Our teams operate in highly regulated, high-availability environments, where operational excellence, reliability, and quality are non-negotiable.

Within Technology at Lilly, the Digital Core organization applies a product, platform, and reliability-first mindset, ensuring that operational capabilities scale sustainably across the enterprise.

**About the Team**

Technology at Lilly builds and maintains capabilities using pioneering technologies like the most prominent tech companies. What differentiates Lilly IT is that we redefine what's possible through tech to advance our purpose, creating medicines that make life better for people around the world, including data-driven drug discovery, connected clinical trials, resilient enterprise platforms, and intelligent digital operations. We hire the best technology professionals from a variety of backgrounds, so they can bring an assortment of knowledge, skills, and diverse thinking to deliver creative solutions in every area of our business.

The Digital Core team leads Lilly's transformation into the Digital and AI era. They inspire digitally empowered teams to new ways of working and accelerate innovation and agility. This team powers and advances the entire company by building and maintaining world-class technology capabilities and platforms.

The Reliability Engineering team is the engineering-first function that owns the stability, observability, and operational quality of a multi-application production estate. It operates in close partnership with the engineering team that builds the agentic automation platform, and is in active transition from human-executed operations to engineering-led, agent-assisted reliability.

**Role summary**

You build the self-healing automation, author the runbooks, and turn root-cause analysis into durable engineering fixes that let the production estate heal itself instead of paging a human. You work within the standards the Senior Principal SRE Engineer sets — SLOs, error budgets, observability — and you're the one who encodes them into working automation and documented procedure.

This is a hands-on individual-contributor role focused on execution and codification rather than cross-estate reliability strategy. You decide, in partnership with the Senior Principal SRE Engineer, which recurring patterns warrant a self-healing investment versus a documented manual runbook, and you build whichever is right.

You are an individual contributor. You do not manage people. You partner daily with the Senior Principal SRE Engineer, the agentic automation engineering team, and Operations on validating outcomes. Success is measured by self-healing coverage, runbooks authored and adopted, reduced recurrence of known failure modes, and the safety record of every automation you sign off.

**What you'll be doing**

**1) Self-healing automation & resilience patterns**

- Design and build self-healing automation — circuit breakers, graceful degradation, automated remediation — for the failure modes that recur most across the estate.

- Run resilience or chaos testing to validate that self-healing patterns behave correctly before they're trusted in production.

- Continuously expand self-healing coverage as new failure modes are identified and proven safe to automate.

- Partner with the Senior Principal SRE Engineer on which failure modes justify self-healing investment versus a documented manual runbook.

**2) Runbook authorship & validation**

- Author and validate the remediation runbooks for the production estate: safe execution order, rollback steps, and exception handling for every documented fix.

- Keep the runbook library current as systems, dependencies, and failure modes evolve, retiring runbooks that no longer apply.

- Define and apply the graduation criteria that let a runbook move from human-executed to agent-assisted to autonomous.

**3) RCA to durable fix**

- Lead or contribute to root-cause analysis for significant incidents, and drive the blameless postmortem process to a durable engineering fix — not just a narrative.

- Convert recurring incident patterns into codified runbooks and, where appropriate, self-healing automation.

- Track fix effectiveness against recurrence, and escalate to the Senior Principal SRE Engineer when a fix needs broader engineering investment.

- Participate in high-severity incident response, including acting as incident commander for escalations within your area.

**4) Partnership with agentic automation & operations**

- Partner with the Agentic Automation Engineering team on which fixes are safe to hand off as agent-assisted remediations, and on the confidence thresholds and human-in-the-loop boundaries that keep them safe.

- Sign off on agent graduation criteria (accuracy over volume, zero P1/P2 caused) before an automation moves to a higher autonomy tier.

- Partner with Operations on outcome validation, feeding what's learned back into the runbook library and self-healing patterns.

**5) Incident response & regulated-environment practice**

- Ensure runbooks and self-healing automation meet Lilly's change-control, audit, and validated-environment standards.

- Document procedures so that audit evidence falls out of normal operation, not a special exercise.

- Mentor other reliability and automation engineers on runbook quality and self-healing design.

- Contribute proven patterns back to the broader reliability practice, in partnership with the Senior Principal SRE Engineer and Senior Architect.

**How you will succeed**:

At the principal engineering level for reliability, success is defined by the durability and safety of what you build:

- Be recognized as the engineer who turns incidents into durable fixes, not repeat pages.

- Demonstrate measurable growth in self-healing coverage and runbook adoption, with falling recurrence of known failure modes.

- Maintain a clean safety record: automations you sign off don't cause P1/P2 incidents.

- Build runbooks and automation that make good practice the default, not a personal habit.

**Your Basic Qualifications:**

- Bachelor's degree in Computer Science, Information Technology, or a related technical engineering discipline, including Software Engineering, Computer Engineering, Information Systems, Cybersecurity, Information Science, Network Engineering, Systems Engineering, Computer Information Systems (CIS), Management Information Systems (MIS), Cloud Computing, Data Science
- 5+ years of progressive engineering experience, with meaningful time as a Site Reliability Engineer, Production Engineer, or equivalent, including hands-on ownership of self-healing automation or runbook-driven remediation for a multi-application production estate.
- Production reliability experience in a regulated or audited environment (GxP, SOX, HIPAA, PCI, or equivalent), including familiarity with change-control discipline, audit evidence, and validated-system constraints.
- Hands-on experience authoring and validating runbooks: safe execution order, rollback steps, and exception handling for real remediation procedures.

- Demonstrated hands-on experience designing, implementing, and operating enterprise-scale SRE platforms, including observability solutions (Splunk, Datadog, New Relic, or Grafana/Prometheus), infrastructure-as-code with Terraform, CI/CD pipeline hardening, Kubernetes-based container platforms, and production workloads hosted on AWS, Azure, or GCP.

- Experience designing self-healing patterns (circuit breakers, graceful degradation, automated remediation) and validating them before they're trusted in production.
- **Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT,J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.**

**What You Should Bring:**

- Hands-on experience designing self-healing automation and running chaos engineering or resilience-testing programs (AWS Fault Injection Service, Gremlin, LitmusChaos, or equivalent) tied to measurable reliability gains.

- Deep AWS fluency across reliability-relevant services (EKS, ECS, Lambda, CloudWatch, X-Ray, Systems Manager, Route 53), and familiarity with AWS Well-Architected Reliability Pillar.

- Experience with AIOps or agent-assisted operations, including designing the guardrails, confidence thresholds, and human-in-the-loop boundaries that make automated remediation safe in production.

- Experience defining or signing off on autonomy/graduation criteria for automation moving toward self-sufficiency.

- Prior experience building or scaling a runbook library across multiple applications or teams.

- Experience operating in pharma, healthcare, financial services, or other regulated industries.
- Track record of contributing meaningfully to root-cause analysis and blameless postmortems, converting findings into durable engineering fixes measured by reduced recurrence rather than narrative quality.

**Leadership expectations:**

- Treats every RCA as unfinished until it produces a durable fix, not just a narrative.

- Combines engineering rigor with operational pragmatism in deciding what gets automated and what stays manual.

- Leads through what they build and how they write, not through org-chart authority.

- Comfortable telling a team that a fix isn't ready for autonomy yet, and showing them what's missing.

- Treats runbook quality and knowledge-sharing as a first-class outcome, not an afterthought.

**Additional information**

Availability to work flexible work hours is/may be required. This team supports continuous operations and may require non-standard work hours, including some work on weekends and holidays.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$66,000 - $158,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Indiana

Sr. Director - Strategic Alliances (SMDD)

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

At Lilly, we serve an extraordinary purpose. For nearly 150 years we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

In Product Research and Development (PRD), we transform molecules into medicines. Our portfolio of medicines is growing and is one of the most diverse and promising pipelines in the industry. PRD has aggressive goals to transition novel therapies from ideas into medicines that provide fundamental health outcomes using novel technologies, innovative business relationships, and world class systems. The Senior Director, Strategic Alliances position seeks a collaborative, inclusive, energetic leader who will define and lead activities with external synthetic CMC collaborations. This role will require significant CMC knowledge, creativity, resilience, and business acumen. The position will work cross-functionally within PRD and across our external network to ensure appropriate capabilities, adequate capacity, and agility that adapt to an ever-evolving global landscape.

This position will provide leadership with strategic external partners to advance Lilly’s Synthetic Molecule Design and Development (SMDD) need for drug substance and drug product development, characterization, and supply of material for toxicology and clinical trials. The Senior Director role will be critical to enable SMDD’s strategic goals related to speed, value, and world class execution on a multifaceted portfolio in a dynamic world landscape. The position will accomplish this through a collaborative approach across external partners to enable novel business constructs, solid operational execution, and robust governance processes. The role will be a member of strategic governance with CDMOs. The relationships with these partners will be instrumental to ensure reliable, high-quality supply of information and material for small molecule, peptide, and oligonucleotide assets.

Responsibilities include:

- *Implement and maintain strategic partnerships*: Lilly’s mission to bring novel therapeutics to patients begins in SMDD. This role will be instrumental to foster collaboration at external partners for the rapid design and development of drug substance and drug product for pre-clinical/clinical phase assets. These relationships are crucial to afford product (supply chain) along with process knowledge needed for global submissions. This role will liaise with Discovery and Manufacturing organizations to enable seamless transition of assets throughout their lifecycle.

- *Ensure Alignment*: Work closely with cross-functional leaders across Lilly CMC, Quality, Procurement, and Safety to translate PRD/SMDD strategic requirements into actionable results with external collaboration partners to ensure delivery of Lilly’s growing portfolio.

- *Drive implementation of novel technology*: Integrate with leadership and technical staff at CDMOs to successfully transfer novel SMDD technology for GMP production. Enable collaborative business relationships to achieve speed and flawless execution to transform molecules into medicines.
- *Champion Operational Excellence:*  Monitor capacity, quality, and performance in alignment with business contracts and perform trend analysis. Develop and drive governance of external operations with CDMOs. Manage and facilitate efficient and effective business processes across supply chain, R&D, compliance, and contractual obligations. Identify and champion best practices.
- *Relationship Management:* Serve as an advocate for partnerships and their objectives. Mitigate business risk, legal uncertainties, and human relationship risks. Work to reduce inefficiencies out of operations and monitor resources devoted to the alliances. Engage in frequent communication to seek 360⁰ feedback from external partners and internal stakeholders on alliance performance/issues. Coach Lilly team members on development of relationship with partners.
- *Laboratory Informatics:* Partner with Tech@Lilly on lab design and data/knowledge capture while assuring alignment with SMDD strategic goals and compliance requirements. Leverage technical laboratory experience and knowledge to advance SMDD practices into state-of-the-art capabilities. Ensure alignment between CDMOs and SMDD.
- Oversee activities related to business operations, including cross-functional issue management, audit support, contract adherence, and ensure alignment with alliance goals. Milestone tracking and awareness.
- Partner with internal Lilly stakeholders to address issues/gaps and ensure alliances are meeting intended goals. Help identify and resolve conflicts. Drive “Voice of the Alliance/Customer” to diagnose relationship health.
- Bridge cultural gaps between Lilly and partner. Coach Lilly team members on development of relationship with partners and vice versa.

**Basic Requirements:**

- Minimum B.S. (Chemistry / Engineering / Biosciences).
- Minimum 15 years’ CMC experience in pharma with minimum of 5 years’ experience of enabling novel CMC technologies/supply chain via contract manufacturing organizations.

**Additional Skills/Preferences:**

- Demonstrated ability to think strategically and solve problems
- Excellent communication and project management skills, ability to lead and influence others with or without authority
- Curious, high capacity of absorbing information and demonstrated learning agility
- Ability to operate effectively in ambiguity
- Demonstrated ability in operational excellence
- Candidate must be able to work cross-functionally, cross-culturally, and with individuals at all levels of the organization
- Strong business acumen

**Additional Information:**

- Travel: Up to 25%
- Location: Indianapolis and onsite

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$151,500 - $222,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Informatics Engineer - Lilly Medicine Foundry

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development in **Lebanon, IN**. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

**What You’ll Be Doing:**

As an Informatics Engineer, you will partner with the Process Translation and Analytical Laboratories functional areas and site, group, and global IT teams to implement and support digital laboratory solutions that enable the Foundry’s operational objectives. Your scope includes key lab systems such as Laboratory Information Management Systems (LIMS), Laboratory Execution Systems (LES), Electronic Lab Notebooks (ELN), Chromatography Data Systems (CDS), and Environmental Monitoring (EM) platforms.

You will be driving and supporting system design, configuration, validation, and release - serving as an IT domain expert (SME) for analytical laboratory IT systems at the Foundry.

**How You’ll Succeed:**

**System Implementation & Configuration**

- Lead system design and configuration sessions with analytical lab SMEs for LIMS, LES, ELN, and CDS platforms, translating business and scientific processes into validated technical solutions.
- Develop and implement Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in compliance with 21 CFR Part 11 and EU Annex 11.
- Lead data integrity requirements across lab systems and ensure audit readiness for regulatory inspections.
- Coordinate instrument integration and data flows between lab equipment and LIMS/LES platforms.
- Support site deployment and upgrade of analytical laboratory IT systems throughout the facility’s startup and operational phases.

**Validation & Compliance**

- Produce and maintain Computer System Validation (CSV) documentation, standard operating procedures (SOPs), and validation plans in alignment with applicable regulatory frameworks.
- Ensure systems remain in a validated state and lead their lifecycle through releases, recapitalization, and retirement.
- Build and maintain awareness of regulatory, legal, and quality requirements impacting the quality control laboratory, ensuring solution requirements comply.

**Collaboration & Readiness**

- Collaborate with site and global IT system teams to ensure operational readiness of laboratory systems supporting the Foundry’s release objectives.
- Act as a key IT SME for analytical laboratory IT systems, organizing and educating peers on system use and best practices.
- Support audits and provide oversight for management reviews, laboratory metrics, equipment records, and laboratory documentation.

**Your Basic Qualifications:**

- Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related technical field.
- 1+ year of experience in information technology, engineering, computer system validation, quality control support, or a related area.
- Experience with LIMS: LabVantage, LabWare
- Experience with ELN: Benchling, Signals Notebook, or equivalent.

- **_Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1._**

**Additional Skills / Preferences:**

- Strong working knowledge of analytical laboratory IT systems including:
- Experience with Computer System Validation (CSV) methodology.
- CDS: Empower, or equivalent
- LES/MES: L7, MODA, or equivalent
- Solid knowledge of CSV process and electronic records/electronic signatures (ERES) requirements.
- Experience working in a GMP-regulated environment (pharmaceutical, biotech, or equivalent).
- Demonstrated ability to prepare and implement IQ/OQ/PQ protocols and associated documentation.
- Experience with API/middleware integration and instrument connectivity between lab equipment and informatics platforms.
- Understanding of data integrity frameworks applicable to GMP lab environments.
- Familiarity with Agile or iterative delivery methodologies in a regulated setting.
- Demonstrated learning agility and curiosity; ability to analyze, anticipate, and resolve complex issues through sound problem-solving.
- Ability to accurately translate business and scientific processes into IT requirements and solutions.
- Effective communicator across diverse forums and audiences, including technical peers, QA, and business customers.
- Certification in relevant IT areas (e.g., ITIL, cloud, AI) is a plus.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$64,500 - $158,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

AbbVie

Director, Portfolio Program Management (Device)

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

The Director, Portfolio Program Management (PPM) will lead complex, high-impact programs within Aesthetics Medicine and serve as a key partner to the Asset Strategy Leader (ASL), asset strategy planner, and deliverable team project managers and co-chairs. In this role, you will help shape asset strategy, align execution plans, and drive delivery across the portfolio. This includes supporting the development and launch of novel medical device products, new clinical indications, and the global expansion of existing products.

As the operational leader of the asset and asset team, you will bring strong leadership, advanced project management expertise, and a strategic enterprise mindset to ensure effective execution and decision making. This role offers the opportunity to influence outcomes across a dynamic, cross-functional environment while contributing to meaningful innovation in medical devices.

Responsibilities

- Partner with the Asset Strategy Leader, asset strategy planner, and deliverable team project managers and co-chairs to define asset strategy and execution plans
- Lead the operational execution of the asset portfolio across products, indications, and projects.
- Drive collaboration and alignment across the asset and deliverable teams through leadership of the asset Project Management Team (PMT).
- Develop, monitor, and manage cross-functional project plans to ensure alignment with asset strategy and team objectives
- Guide teams through key decision points, governance reviews, and stage-gate approvals
- Proactively identify, assess, and resolve project risks and issues
- Support timely execution of portfolio milestones, timelines, and budget expectations
- Facilitate effective cross-functional team meetings, including agendas, action items, and decision tracking
- Communicate portfolio status, risks, and key decisions to leadership and stakeholders
- Contribute to departmental initiatives, documentation, and reporting
- Mentor junior team members and help strengthen team capability
- May provide oversight or support for Aesthetics Therapeutic Area Strategy Council (TASC) meetings

Qualifications

- Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related discipline
- 8–12 years of experience in medical device R&D and/or pharmaceutical R&D
- At least 5 years of direct project management experience in drug/device or product development projects
- Strong knowledge of global device development, product registration, and launch processes
- Demonstrated ability to manage complex, cross-functional projects
- Strong communication, stakeholder management, and meeting facilitation skills
- Proficiency with enterprise-level project and portfolio management tools
- Ability to work independently with minimal oversight
- Strong analytical skills, sound judgment, and attention to detail

Preferred

- PMP certification
- Experience mentoring or coaching team members
- Familiarity with governance boards and portfolio-level decision making

What Success Looks Like

- Clear alignment between asset strategy and execution plans
- Strong cross-functional collaboration and team engagement
- Proactive issue identification and effective risk mitigation
- Timely, well-informed decisions supported by clear analysis
- High visibility and trusted partnership with leadership

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Director, Computational Sciences

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

**Organization Description**

The Molecular Profiling and Drug Delivery (MPDD) function within the Synthetic Molecule CMC organization is accountable for a broad range of deliverables across multiple stages of drug discovery and development. From virtual screening, lead generation, and lead optimization through candidate selection, MPDD scientists use state-of-the-art automation and computational tools, supported by expertise in biopharmaceutics, drug delivery, and solid-state chemistry, to collaboratively design and advance candidates with a higher probability of success into development and to inform clinical drug-delivery strategy. From candidate selection through clinical proof of concept and product launch, MPDD scientists work on cross-functional teams to identify the commercial solid form of the active pharmaceutical ingredient (API) and establish structure–property–performance correlations that help deliver robust commercial processes and align control strategies across drug substance and drug product.

Computational chemists within AbbVie’s MPDD organization partner across Development Sciences and Discovery Sciences in three key focus areas: molecular design and profiling, chemical transitions, and materials design across synthetic modalities. Their work supports the design and advancement of compounds, materials, and formulations with optimal developability properties from lead optimization through commercial development, aligned with the broader goal of advancing first-in-class and best-in-class clinical candidates. The team develops hierarchical modeling approaches that integrate physics-based atomistic methods, including molecular dynamics and quantum mechanics, with machine learning, artificial intelligence, and hybrid physics-informed AI/ML models across hardware platforms for precision in predictions. In close collaboration with medicinal chemists, data scientists, materials scientists, formulation scientists, engineers, and molecular modelers, the team embeds these tools into screening funnels across medicinal chemistry design cycles and preclinical and clinical drug-substance and drug-product development, while maintaining a strong partnership ecosystem to source and leverage external innovation.

**Job Description**

AbbVie’s MPDD organization is seeking a visionary leader with a successful track record of innovation and deliverables in a drug discovery setting to head a global computational chemistry team of 10-12 talented scientists and matrixed leadership of broader modeling community across the larger Synthetic Molecules CMC (SM CMC) and Development Sciences Organizations. This leader will report to the Global Head of Molecular Profiling and Drug Delivery organization and be a member of the SM CMC Extended Leadership Team. In partnership with other key leaders in Discovery Research, Development Sciences and Information Research, they will be responsible for cocreating a forward-looking strategy that realizes the promise of Computational Sciences and AI enabled drug discovery and development to deliver on a portfolio of new and improved therapies for patients in alignment with AbbVie’s broader R&D priorities and AI strategy across synthetic modalities. The ideal candidate will bring a strong record of project impact, capability development, and external partnership building across the mid- to late-stage discovery process, with expertise in quantum mechanics, atomistic molecular simulations, including molecular dynamics, and AI/machine learning. Prior experience mentoring early/mid-career scientists in matrixed and/or direct reporting relationships, with demonstrated ability to lead and influence through cross-functional boundaries.

**Responsibilities**

**Strategic Direction:**

- Interfaces closely with Development Sciences and Discovery leaders to align strategies and research activities on pipeline programs.
- Partners across functions including Discovery Research, Development Sciences and Information Research to develop and implement strategies, methods and operating models to drive Computational Sciences and AI enabled drug discovery.
- Autonomously manages multiple projects and team leaders, making decisions that impact long term company strategy.
- Identifies, creates, and manages or oversees an eco-system of external research collaborations across academia and tech.
- Makes highly critical but educated decisions based on review of all important information and data.

**Scientific Leadership:**

- Manages project intake, capacity planning for small molecule portfolio of projects and aligns scope, timelines and decision points for support of med chem optimization.
- Leads innovation in methodologies, integration across platforms, and emerging technology trends to facilitate development and deployment of cutting-edge stage-appropriate full-stack solutions across mid-late discovery and early clinical development.
- Guides the identification, development, pilot, implementation, and eventual democratization of stage-appropriate computational models that leverage advanced computational techniques to enable the design and optimization of drug candidates across synthetic modalities
- In collaboration with Information Research ensures robust model/data management and democratization that drives fuller utilization of the tools, their continued development, and refinement.

**People Impact:**

- Able to develop and execute innovative, informed, and effective solutions to inter/intra group/project conflicts, resource allocation issues, and scientific setbacks.
- Create a stimulating and innovative work environment that attracts, retains, develops and motivates top talent.
- Ensure that employees are developed to their full potential and assist them in identifying appropriate development opportunities within the organization.

Qualifications

- Bachelor’s degree or equivalent education in chemistry, computational chemistry, pharmaceutical sciences, chemical engineering, computer science, or a related scientific field, with typically 18+ years of related work experience inclusive of managerial experience leading scientific research teams; Master’s degree or equivalent education, with typically 16+ years of related work experience inclusive of managerial experience leading scientific research teams; or a PhD in chemistry, computational chemistry, pharmaceutical sciences, chemical engineering, computer science, or a related field, with typically 12+ years of related work experience inclusive of managerial experience leading scientific research teams.
- Strong track record of people, technical, and research project management with significant impact.
- Strong track record of high-impact scientific achievement including a robust publication record.
- Strong track record of cross functional collaboration.
- Knowledge and experience in state-of-the-art computational methodologies, technology platforms and emerging trends, and associated workflows to accelerate discovery and development of therapies with precision in predictions in a fast paced and creative environment.
- Strong written and oral communication skills with executive presence.
- Strong leadership skills with ability to navigate multiple stakeholders while engaging and motivating staff.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Illinois

Director - Dissolution Science & Biopharmaceutics

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the preclinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, antibody-drug conjugates (ADCs) and other emerging therapeutic modalities. SMDD fosters a culturally diverse, high-performing workforce with deep technical expertise across these platforms.

This is a technical leadership role that combines laboratory and modeling work with strategic influence across the product development lifecycle. You will have access to Lilly's world-class dissolution, biopharmaceutics modeling (PBBM), and analytical capabilities at the Lilly Technology Center in Indianapolis.

SMDD is seeking a Director / Senior Director / Executive Director to lead the dissolution science and biopharmaceutics function for small molecule drug products, from early-phase development through commercialization. In this role, you will lead the product performance strategy on multidisciplinary project teams — developing and justifying dissolution methods, building biopharmaceutics risk assessments and biowaiver strategies, authoring CMC and biopharmaceutics regulatory content for global submissions and responses to health authority questions. In addition, you will drive the innovation agenda and contribute to Lilly’s external scientific presence in this area. The role includes management of a small team of 1–5 scientists and direct responsibility for multiple projects as well as technical oversight across a broader portfolio. You will work in close partnership with formulation, analytical, engineering, ADME, clinical pharmacology, and regulatory colleagues across Lilly Research Labs.

**Responsibilities**

**Core Technical Scope**

- Develop, validate, and justify phase-appropriate dissolution methods that link in vitro drug product performance to in vivo behavior, spanning immediate-release and modified-release oral solid dosage forms. Apply conventional and biorelevant/predictive dissolution as well as novel approaches to assess oral performance of drug molecules and formulations in humans.
- Build and execute biopharmaceutics strategies using in vitro, in vivo, and in silico tools — including physiologically based biopharmaceutics modeling (PBBM) — to assess oral absorption, predict bridging risk, and establish clinically relevant specifications.
- Author and defend dissolution and biopharmaceutics content in IND/CTAs, NDA/MAAs, and responses to health authority questions across global markets, including biowaiver justifications and IVIVC/IVIVR dossiers.

**Strategic and Cross-Functional Leadership**

- Partner with formulation scientists, analytical chemists, engineers, clinical pharmacologists, and regulatory colleagues to define product performance control strategies — including specifications, dissolution method lifecycle management, and post-approval change strategies.
- Support the design of new dosage forms and drug delivery technologies by applying pharmaceutical sciences knowledge spanning formulation, biopharmaceutics, pharmacokinetics, and patient-centered drug product design.
- Plan and lead short-term and long-term dissolution and biopharmaceutics development activities across assigned programs and broader portfolio. Develop technical agendas and timelines, recommend resource allocation, communicate progress, and propose changes in direction when warranted.

**People Leadership and External Engagement**

- Directly lead a small team (1–5 scientists), providing technical mentorship, career development, and performance coaching.
- Influence and engage the external scientific community through publications, conference presentations, and collaborations that advance Lilly’s dissolution science and biopharmaceutics capabilities.
- Evaluate and integrate emerging science from adjacent disciplines (e.g., formulation science, PAT, modeling and simulation) into dissolution and biopharmaceutics practice.

**Basic Qualifications**

- Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, Physical Chemistry, Chemical Engineering, or related discipline with 8+ years of pharmaceutical industry experience in drug product development and commercialization. (Will also consider M.S. with 12+ years or B.S. with 15+ years of directly relevant experience.)
- Technical leadership experience in dissolution science, biopharmaceutics, and product performance for small molecule drug products, with demonstrated ownership of deliverables from early development through regulatory submission, including hands-on experience with biorelevant dissolution testing, discriminating method development, and dissolution method lifecycle management across clinical and commercial phases.
- Track record of authoring CMC and biopharmaceutics regulatory sections (dissolution-related content in CTD Modules 3.2.P.2, 3.2.P.5, 2.7.1) and responding to health authority questions on product performance topics.
- Demonstrated experience applying PBBM to biowaivers, bridging risk assessments, clinically relevant dissolution method justification, or specification setting.
- Demonstrated knowledge of applicable CMC regulatory requirements (FDA, EMA, and other major health authorities) and emerging regulatory trends in dissolution and biopharmaceutics.

**Additional Skills/Preferences**

- Strong publication record and external scientific engagement in dissolution science, biopharmaceutics, or related fields.
- Proficiency with one or more biopharmaceutics modeling platforms (e.g., GastroPlus, Simcyp, DDDPlus, STELLA) and experience establishing IVIVC/IVIVR or bioequivalence safe spaces.
- Knowledge of formulation development and physical pharmacy of small molecules, including poorly soluble compounds and enabling formulation technologies (e.g., amorphous solid dispersions, spray-dried intermediates).
- Demonstrated ability to influence cross-functional alignment and negotiate technical decisions across formulation, analytical, engineering, ADME, clinical pharmacology, and regulatory functions.
- Experience mentoring and developing technical talent at the scientist and senior scientist level.

**Additional Information**

- Travel: 0 to 10%
- Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$148,500 - $257,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Scientific Lead - Global Sample Management

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Position Summary**

At Lilly, the molecules that become medicines start as ideas — and behind every breakthrough is a team that ensured the right compound reached the right assay at the right time. The work of Global Sample Management is foundational to drug discovery, and the people who do it well make science move faster.

The Scientific Lead is responsible for operational leadership of Eli Lilly's Indianapolis sample management site within the Global Sample Management (GSM) organization. This role leads a blended team of full-time employees and contractors across a wide remit of sample activities in service of large-scale, high throughput sample production and data stewardship, ensuring consistent, high-quality delivery to discovery teams across modalities. As GSM accelerates its adoption of intelligent automation and agentic workflows, the Scientific Lead will be at the center of that transformation — sustaining operational excellence today while actively shaping what sample management looks like tomorrow.

This lab-based role serves as the primary point of escalation for site-level issues, a liaison between the bench and leadership, and a driver of process, capacity planning, and staff development. The ideal candidate brings strong scientific and operational credibility, people leadership experience, and a genuine appetite for building the next generation of high-throughput sample management capability. The level of appointment will be determined by the experience and qualifications of the selected candidate.

**Responsibilities**

- Oversee daily operations across all sample management functions, including compound registration, plate preparation, neat/weigh operations, liquid handling, and sample delivery to internal and external stakeholders.
- Serve as the primary operational point of contact for Indianapolis-based discovery scientists, triaging requests, managing priorities, and ensuring turnaround commitments are met.
- Own site throughput, queue status, and processing time metrics, escalating capacity constraints and service disruptions to leadership with clear data and recommended actions.
- Maintain readiness across instrumentation and automation platforms, coordinating maintenance, troubleshooting, and vendor engagement as needed.
- Provide direct day-to-day leadership for the site team, including scheduling, task assignment, performance feedback, onboarding, and development planning to build capability across core GSM competencies.
- Foster a culture of safety, accountability, and continuous improvement.
- Partner with leadership on workforce planning, capacity forecasting, and succession considerations for key roles.
- Ensure data integrity, quality, and compliance across LIMS and related systems by maintaining accurate material records, supporting compliance expectations, and strengthening traceability through standardized workflows.
- Drive process improvement by identifying bottlenecks, inefficiencies, and risk points, and implementing workflow, automation, or robotics enhancements in collaboration with global sample management and cross-functional partners.
- Document and maintain standard operating procedures (SOPs) for critical LCC processes and ensure the team is trained to current standards.
- Engage with medicinal chemistry, biology, and computational teams to understand evolving sample management needs and proactively align GSM capabilities.
- Collaborate across the sample management network to share best practices, enable sample transfers, support network-level capacity balancing, and represent Indianapolis operations in project discussions with clarity and confidence.
- Contribute to strategy and execution of the expansion of operations into new modalities.

**Basic Requirements**

- PhD in chemical, biological, or engineering sciences, or a STEM field AND 2+ years of hands-on laboratory experience in compound management, sample management, or a closely related discipline;
- or BS/MS in chemical, biological, or engineering sciences, or a STEM field AND 5+ years of hands-on laboratory experience in compound management, sample management, or a closely related discipline.

**Additional Skills and Preferences**

- Proficiency with LIMS or comparable sample tracking and inventory management systems.
- Hands-on experience with laboratory automation and instrumentation relevant to sample management (e.g., liquid handlers, acoustic dispensers, automated storage systems).
- Demonstrated experience leading or supervising a laboratory team, with direct accountability for people, priorities, and performance outcomes.
- Strong organizational skills with the ability to manage multiple priorities simultaneously in a high-throughput environment.
- Deep knowledge of high-throughput screening workflows and plate-based assay preparation at scale.
- Demonstrated aptitude for agility in sustaining throughput commitments during staffing gaps, demand spikes, and system transitions.
- Exceptional communication skills—written and verbal—with the ability to translate operational data into clear summaries for scientific and leadership audiences.
- Demonstrated ability to work across multidisciplinary teams and build effective working relationships at all levels of the organization.
- Experience generating assay-ready plates for high-throughput screening across geographies.
- Experience with automation platforms common to compound management (Beckman Echo, Tecan, High Res Biosystems, Hamilton, Azenta) and associated control software (Cellario, Fluent Control or equivalent).
- Experience supporting or managing CRO logistics for sample shipment and external compound delivery.
- Exposure to multi-modality sample types (small molecules, peptides, biologics, oligonucleotides, or ADCs) and associated handling and tracking requirements.
- Working knowledge of programming, data tools, or modern AI tools (Python, Excel, Claude, for example) used in a laboratory operations context.
- Exposure to high-throughput screening or biochemical assay operations, with an understanding of how sample quality and format impact assay outcomes.
- Prior experience in a regulated or GxP-adjacent environment with awareness of data integrity and compliance expectations.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$126,000 - $204,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Post-Doctoral Associate, Visual Inspection

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**TECHNICAL SERVICES & MANUFACTURING SCIENCE**

**Post-Doctoral Associate, Visual Inspection: Full Time (Fixed Duration)**

**Company Overview**

Lilly, a leading innovation-driven corporation is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better – through medicines and information – for some of the world's most urgent medical needs. Founded over 145 years ago, the company has sustained a culture that values excellence, integrity and respect for people. This has resulted in Lilly frequently being ranked as one of the best companies in the world at which to work. Lilly knows its business has prospered because of its employees – people with a talent for innovation and a passion for making a difference by finding treatments for the most stubborn diseases; people whose talent is matched by their generosity, and people with strong values and a determination to prevail, regardless of the challenges. Join our team – and make a difference in improving health for people all over the world!

Post-Doctoral Associates at Lilly are responsible for:

- Ensuring reliability of our manufacturing and quality systems
- Searching for and implementing continuous improvements
- Driving technical and scientific projects
- Maintaining our processes in a state of compliance with US and global regulations
- Designing and developing inspection strategies and control systems for parenteral drug products

The position is a Post-Doctoral Associate position within the Visual Inspection (VI) group of the Technical Services/Manufacturing Science (TS/MS) organization. The position will provide technical and scientific support within a dynamic manufacturing environment for the development of automated and manual inspection strategies used to detect particulate and container defects in parenteral drug products. The successful candidate will be responsible for designing and executing experiments to advance inspection science, probability of detection (PoD) modeling, and particle characterization, as needed.

Associates actively contribute to the TS/MS organization and have extensive opportunities for involvement in cross-functional teams. This position allows for development of a comprehensive understanding of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions.

**Key Objectives/Deliverables:**

- Understanding the scientific principles required for visual inspection of parenteral drug products, including the interaction of defect type, container, and inspection method.
- Understand the formation, classification, and risk profile of particulate and container defects (vials, syringes, cartridges).
- Develop appropriate laboratory-scale models and defect libraries to support inspection qualification studies.
- Design, conduct, and analyze statistically-designed experiments (e.g., probability of detection studies, Knapp reject zone methodology) to deepen inspection process understanding and optimize detection performance.
- Evaluate AI-based strategies for optimization of defect detection performance.
- Understand scale-up requirements and, as needed, partner with manufacturing sites and CMOs to conduct appropriate technology transfer work.
- Provide technical support for automated and manual inspection qualification activities.
- Strong technical writing and documentation of all technical work.
- Mentor lab associates to enhance their technical capabilities.
- Participate in technology transfer as needed.
- Ability to work well independently and collaboratively.

**Basic Requirements:**

- Ph.D. in scientific disciplines of Engineering, Chemistry, Materials Science, Physics or related fields.
- Demonstrated experience and proficiency in the areas of particle characterization, materials analysis, or optical/imaging systems.
- Requires a record of publication in peer reviewed journals and presentations / posters at scientific conferences.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Information**

- This Post-Doctoral Associate position is not permanent. It is for a fixed duration of two years with potential to extend to 3 years and for maximum of up to 4 years. You will have opportunities to apply for full-time positions after your duration is complete.
- Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

LOCATION:

- Indianapolis, IN

**ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER**

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$58,000 - $123,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Industrial Electrician- Medium Voltage, Instrumentation & Utilities

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Organization Overview:**

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

**Position Brand Description:**

The Industrial Electrician has the responsibility of servicing, troubleshooting, and maintaining equipment within the Lilly Technology Center manufacturing site that includes instrumentation, electrical, high purity water, compressed air, steam, chilled water, glycol, city water, and sewers. Responsible for ensuring safe, reliable, and efficient operations across all utility locations, while collaborating with and supporting multiple maintenance crafts to meet operational and maintenance objectives.

**Key Objectives/Deliverables:**

- Perform preventative and corrective maintenance on medium voltage electrical equipment (13.8KV main switch gear, circuit breakers, relays, motor starters, ground fault interrupts).
- Perform preventative maintenance on complex electrical equipment (motor control centers, variable-speed drives, programmable logic controllers, etc.).
- Troubleshoot and diagnose electrical equipment problems and make appropriate repairs to minimize downtime.
- Perform modifications and new installations of electrical equipment (e.g., conduit, conductors, lighting, branch circuits, etc.).
- Diagnose complex electrical problems to effect repairs and restore equipment/systems to operating condition.
- Perform preventative/corrective maintenance and calibration, modifications and new installations on process instrumentation (temperature, pressure, flow, pH, conductivity, TOC, control valves, etc.)
- Demonstrate the ability to read P&ID drawings.
- Consistently comply with safety rules and closely follow approved procedures to ensure cGMP compliance.
- Document all work by following Good Documentation Practices.

**Basic Requirements:**

- Experience maintaining equipment in an industrial utilities environment. Familiarity with any of the following is an advantage: high purity water, compressed air, steam, chilled water, glycol.
- Candidates must hold a valid driver’s license.
- Willingness to respond to call-ins and work scheduled overtime is necessary.
- Ability to lift up to 40 pounds is required.
- Must be able to tolerate exposure to varying temperatures while performing duties outdoors in all weather conditions.
- A minimum of three years of relevant work experience is mandatory.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Skills/Preferences:**

- Associate's degree, Technical Certificate in an electrical discipline, or equivalent industrial electrical experience; military electrical training accepted. Experience with medium-voltage electrical systems (4.16kV preferred).
- Experience performing and troubleshooting electrical maintenance equipment in a manufacturing, industrial, or production environment.
- Ability to read, interpret, and work from electrical schematics, prints, and technical documentation.
- Knowledge of safe maintenance practices, work procedures, and documentation requirements.
- Proficiency using CMMS software (e.g., Maximo) for work order management and maintenance tracking. Microsoft Applications Knowledge (Word, Excel, Outlook, PowerPoint).
- Strong communication skills and ability to work effectively in a team environment.
- Experience collaborating with multiple skilled trades and supporting cross-functional maintenance activities.

**Education Requirements:**

- High school diploma or equivalent

**Additional Information:**

- This position is scheduled for 8 hours per day, Monday through Friday.
- Temporary shift changes may occur.
- Hazardous operations within Utilities include exposure to acid, steam, caustic substances, high pressure, and high temperatures.
- Personal protective equipment is required at all times.
- Work involves awkward positions, cramped quarters, ladders, and scaffolding.
- Employment requires working during summer and year-end company breaks.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$21.27 - $41.25

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$21.27 - $41.25

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Advisor - Program Manager - GFD

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Global Facilities Delivery (GFD) Organization delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of design, construction, and qualification contractors. Many of the assets delivered focus on medical innovation and delivering innovative solutions to patients. Some of the assets delivered will expand the supply of existing medicines or strengthen the supply chain.

**Key Objectives/Deliverables:**

- Project Management: Lead teams to deliver large programs of at least $400M USD or more in capital assets and/or business-critical in nature. These teams will consist of both Lilly and Non-Lilly professionals, working to safely achieve project objectives from front-end planning (conceptual design) in a Brownfield or Greenfield site through operational qualification (cradle to grave). Project objectives are defined as delivering asset capability or capacity with safety, cost, schedule, and quality assurance.
- Interface/Communication: Ability to lead from a regional distance from corporate headquarters while developing and maintaining effective communication with GFD leadership, the project team, governance teams, business partners, and other stakeholders. Facilitate issue resolution, anticipate scope changes, and implement project work safely with quality, speed, and value.
- Compliance: Lead with a disciplined, structured approach to project management based on compliance with Company Policies and Procedures.
- Safety/Environment: Develop and maintain safety and environmental execution plans for projects. Ensure compliance with safety and environmental policies, procedures, and work rules for project personnel, contractors, and subcontractors from conceptual design through operational verification.

**Minimum Requirements:**

- Bachelor of Science in Engineering or a related technical field (e.g., project management, construction management).
- Minimum of 10+ years of previous experience in capital project delivery in industrial or manufacturing facilities.
- Willingness to relocate and/or travel to locations outside of home state/country.

**Additional Preferences:**

- Project Size: Previous experience leading projects or multiple projects of \>$100MM in size.
- Previous experience managing greenfield projects.
- Pharmaceutical manufacturing experience.
- Capital Project Management experience in pharmaceutical manufacturing facilities such as: Bulk API, sterile products, secondary packaging, devices, and to a lesser extent, lab projects.
- Experience in the following areas: GMP manufacturing, LEAN, automation, construction, construction quality, project controls, the engineering disciplines, safety, and scheduling.
- The capacity to achieve results and influence through people.
- Demonstrated ability to work from long distances with little supervision, exhibiting good judgment in decision-making without the need for managerial approval, while keeping management informed and engaged on critical issues.
- Effective communication skills, both written and verbal.
- Ability to influence personnel and organizations without having direct administrative responsibility for them.
- Competency in a foreign language(s).
- Professional Engineer (PE) or equivalent technical certification.
- Project Management Professional (PMP) certification.
- Experience in working and/or living outside the U.S.
- Demonstrated willingness to embrace the concept of continuous improvement and be an agent for change.

**Additional Information:**

- Travel is required and will vary by project.
- Full relocation to one of the posting locations listed on this requisition is required for the duration of the project. Throughout the hiring process, you may share preferences and further detail about your mobility with the hiring team.
- This is an onsite role; onsite presence is required (this is NOT a remote role).
- Multiple job levels can be hired on this posting, and business title will vary based on job title (i.e. Advisor – Program Manager – GFD or Sr. Advisor – Program Manager – GFD).

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$129,000 - $209,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Sr. Program Director

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Global Facilities Delivery (GFD) Organization, part of Corporate Engineering and Continuous Improvement delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of design, construction, and qualification contractors. Many of the assets delivered focus on medical innovation and delivering innovative

solutions to patients. Some of the assets delivered will expand the supply of existing medicines or strengthen the supply chain.

**Key Objectives/Deliverables:**

**Project Management:**

Lead and manage teams to deliver large programs of at least $1BN USD or more in capital assets and/or highly business-critical in nature. These teams will consist of both Lilly and Non-Lilly professionals to safely achieve project objectives from front-end planning (conceptual design) in a Brownfield or Greenfield site through operational qualification (cradle to grave). Project objectives are defined as delivering asset capability or capacity with safety, cost, schedule, and quality assurance.

**Interface/Communication:**

Ability to lead from a regional distance from corporate headquarters and while developing and maintaining effective communication with GFD leadership, the project team, governance teams, business partners, and other stakeholders. Facilitate issue resolution, anticipate scope changes, and implement safely with quality, speed, and value.

**Compliance:**

Lead with a disciplined, structured approach to project management based on compliance with Company Policies and Procedures.

**Safety/Environment:**

Develop and maintain safety and environmental execution plans for projects. Ensure compliance with safety and environmental policies, procedures, and work rules for project personnel, contractors, and subcontractors from conceptual design through operational verification.

**Minimum Requirements:**

- Bachelor of Science – Engineering field or related to project management or equivalent experience.
- Minimum 15+ Years of previous experience in capital project delivery in industrial or manufacturing facilities.
- Previous experience managing greenfield projects.
- Willingness to relocate and/or travel to locations outside of home state/country.

**Additional Preferences:**

- Previous experience on projects or multiple projects of $1Bn.
- Pharma manufacturing experience.
- Capital Project Management Experience in Pharma manufacturing facilities, such as: Bulk API, sterile products, secondary packaging, Devices and to a lesser extent lab projects.
- Experience in the following areas: GMP manufacturing, LEAN, Automation, construction, construction quality, project controls, the engineering disciplines, safety, scheduling.
- The capacity to achieve results and influence through people is critical.
- Demonstrated ability to work from long distances with little supervision.
- Must exhibit a good sense of judgment in decision making, without the need for management approval while at the same time keeping management informed and engaged on critical issues.
- Effective communication skills both written and verbal.
- Ability to influence personnel and organizations without having direct administrative responsibility for them.
- Competency in a foreign language(s).
- Professional Engineer (PE) or equivalent technical certification.
- Project Management Professional (PMP) certification.
- Experience in working and/or living outside the U.S.
- Demonstrated willingness to embrace the concept of continuous improvement and be an agent for change.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$159,000 - $233,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Director / Senior Director – Cheminformatics and Applied AI

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Lilly Small Molecule Discovery is an organization purpose-built to create molecules that make life better for people. We focus on using cutting edge science to unlock new approaches that can treat people suffering from diseases with poor treatment options. We continually challenge ourselves to deliver molecules that can provide breakthrough efficacy with the highest possible safety margins. We are dedicated to optimizing our mindset, technology, and processes for faster, more nimble execution. Our success is built on a culture that empowers innovative problem solving through open collaboration and individual accountability.

Position Summary

Lilly’s Early Molecule Discovery (EMD) mission is to identify hits and deliver optimized Leads that advance though Advanced Molecule Design (AMD) into quality drug candidates and, ultimately, breakthrough medicines.

The primary measure of success in this band is portfolio-level impact — resolving the hardest scientific questions through hypothesis- and data-driven approaches, delivering the insights that change the trajectory of multiple programs, and building the scientific capabilities that raise the ceiling on what the function can achieve.

The Director/Senior Director of Cheminformatics and Applied AI are recognized scientific authorities whose impact extends well beyond individual projects to define platform capabilities, shape discovery strategy, and advance the state of the art within Lilly and across the field. These are not primarily execution roles — they are roles of scientific vision, organizational leadership, and enterprise influence.

Key Responsibilities

Portfolio Impact: Scientific leadership through direct technical credibility

- Serve as a recognized expert in cheminformatics and applied AI/ML, who consistently delivers high-impact scientific contributions and strategies that resolve critical project challenges to advances programs through major milestones.
- Develop and apply cheminformatics, statistical, and AI/ML methods that improve hit identification and hit-to-lead across screening technologies, e.g., DNA-encoded library (DEL), high-throughput screening (HTS), virtual screening (VS), fragment-, and affinity-based approaches, and across modalities, e.g., small molecule, macrocyclic peptide, and molecular glues.
- Drive the analytical and machine learning methodology development and applications for the DEL platform: enrichment analysis and denoising of selection data, models trained on DEL output, and their extension to VS of ultra-large synthesizable chemical space.
- Identify hard scientific problems limiting program progress and take personal ownership of driving solutions through rigorous and creative scientific thinking.
- Stay current with external scientific advances, emerging methodologies, techniques, and enabling technologies and rapidly evaluate, adapt, and deploy those most relevant for advancing program objectives.

Enabling: Scientific Influence and Strategic Partnerships

- Partner with Computational Chemistry and Cheminformatics leadership to define platform-level strategy, resource investments, and organizational priorities for Cheminformatics and Applied AI.
- Encourage close collaborations and initiatives with computational chemistry, medicinal chemists, Ligand-ID, Biophysics and Chemical Biology cross pillar colleagues and other cross function partners such as ADME, that culminate in the generation of well poised analysis, robust models and testable hypotheses.
- Serve as a scientific advisor to senior leadership across discovery, therapeutic areas, and technical functions; provide expert guidance across multiple programs; influence portfolio-level decisions through authoritative scientific judgment.
- Identify and contribute to external innovation opportunities that enhance our ability to deliver quality differentiated hits and leads.
- Build and leverage external scientific networks e.g. academic collaborators, CROs, technology vendors, professional societies, to access groundbreaking scientific expertise and capabilities.
- Cultivate cross function collaborations with Discovery & Technology Platforms and Tech@Lilly colleagues to help guide the delivery of transformative digital solutions.
- Foster an environment that supports open scientific debate and bold, evidence-based decisions; champion integration of complementary fields to improve translational impact across the discovery continuum.

Supporting: Team Development and Culture

- Serve as a role model for scientific excellence at all levels of the organization; establish clear expectations for rigor, independence, innovation, and measurable impact.
- Actively mentor and develop diverse scientific talent across sites and functions; develop team members' ability to deliver higher-impact science and reinforces curiosity; invest in building the next generation of scientific leaders.
- Challenge the status quo; Lead complex (cross-functional) initiatives that leverage diverse perspectives, to drive improvement, and accelerate adoption of new scientific approaches.
- Champion a ONE TEAM, SAME TEAM mindset; exemplify Lilly leadership behaviors and model ground-breaking transparency in surfacing issues that detract from our mission to accelerate the delivery of our portfolio.

Safety & Compliance: Model Safety Leadership Through Personal Practice

- Demonstrate an unwavering commitment to safety-first practice: complete required safety training and raise concerns immediately.
- Follow all site safety, environmental, and regulatory compliance requirements; actively reinforce a non-negotiable safety-first team culture and drive solution of concerns at the appropriate organizational level.

Basic Requirements

- PhD in Cheminformatics, Computational Chemistry, Chemical Engineering or related field with a minimum of 4+ years of drug discovery experience within a pharmaceutical/biotech setting; or BS/MS with 8+ years of equivalent experience.

Additional Preferences

- Proven ability to provide scientific leadership that shapes organizational capabilities, scientific culture, and strategic direction at the project, platform, and/or portfolio level.
- Demonstrated drug-hunter experience with a track record of successfully developing, applying, and championing (new) cheminformatics and applied AI/ML technologies to advance discovery programs through major milestones, such as hit ID, hit-to-lead progress.
- Broad understanding of modern data science applied to drug discovery, including predictive modeling, generative design, molecular representations, and model validation and uncertainty.
- Proficiency in Python and SQL, cheminformatics toolkits (RDKit, OpenEye), and machine learning libraries (PyTorch, scikit-learn). Fluency with AI coding and research assistants such as Claude Code.
- Proven ability to inspire and collaborate with scientists across teams and functions to achieve aspirational goals with demonstrated translation to drug discovery outcomes.
- Exceptional track record of scientific innovation evidenced by publications, patents, invited presentations, or other indicators of field-level recognition and external scientific impact.
- Outstanding written and verbal communication skills, with demonstrated experience presenting to and influencing senior scientific and business leadership.
- Data dependent decision maker; agile and ready to change research priorities as necessary for success.
- Demonstrated interest in building inclusive teams and commitment to mentoring early career computational chemists.
- Domain expertise in target classes and modalities aligned with Lilly’s strategic interests.
- Project or program leader experience.
- Excellent understanding of the phases of drug discovery from target assessment through to candidate selection and the fundamental concepts of drug design, medicinal chemistry and ADME.

Physical Demands / Travel

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

There will be some travel associated with this role.

Work Environment

This is an onsite office position within Lilly Research Laboratories.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$193,500 - $308,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Senior Engineering Advisor (SDD)

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Job Position Overview:**

Support the development of key solutions or process improvements for Lilly manufacturing processes or industry defined subjects. Engineering Consultants are expected to bring key expertise and knowledge to the table and lead development processes through research, process engineering laboratory experimental efforts, and direct interactions with manufacturing sites, development and functional areas.

This role provides technical leadership (including oversight of the community, technology development, knowledge sharing, mentoring and coaching of others, etc.), provides technical –guidance and support to sites and external manufacturing organizations, supports major capital projects, and networks with the external community at large.

**Key Objectives/Deliverables:**

- Provides engineering technical leadership globally in spray dried technology for amorphous solid dispersions, including solvent system selection, and process parameter definition.
- Collaborates cross-functionally in manufacturing and development to direct discipline activities, new technology development, assessments, and deployment. Stay abreast of current industry trends in spray drying, hot melt extrusion alternatives, and emerging amorphous stabilization approaches.
- Collaborates with sites globally, assisting with technical evaluations, technology assessment and specific problem resolution including troubleshooting, root cause analysis, and productivity improvements.
- Develops informal and formal networks with manufacturing and development peers to identify opportunities to apply engineering principles to improve Lilly operations.
- Develops experimental programs, protocols and models to address technical problems. Includes development and application of vessel and other scale-down models.
- Supervises laboratory experiments and partner with lab team to assure that experiments are carried out safely and with high quality and speed.
- Prepares technical reports and other supporting documentation for knowledge sharing.
- Leverage external resources to stay current in specific area of technology expertise and when necessary to complement internal resources.

**Basic Qualifications:**

- BS Engineering or Science
- 8+ yrs manufacturing experience in a GMP regulated environment (preferably pharmaceutical manufacturing)

**Additional Skills/ Preferences:**

- Demonstrated technical abilities and abilities in engineering as applied to the manufacturing platforms utilized in pharmaceutical manufacturing oral solid dose.

- Advanced degree in engineering (MS or PhD).
- Expertise in particle characterization and analysis
- Experience with process modeling tools

**Additional Information:**

- Position Location: **Indianapolis**
- Travel Percentage (%): **up to 20%**
- Shift Information: Days

**NOTE:**  This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$129,000 - $209,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Associate Director – Biologics Process Engineering, Lilly Medicine Foundry

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Associate Director, Biologics Process Engineering provides leadership and direction to the process engineering team to ensure that engineering deliverables are sufficiently resourced and qualified to support biologics drug substance manufacturing and the broader business agenda. This role is responsible for the productivity and development of process engineers with the purpose of ensuring that reliable and compliant equipment and systems are used in the manufacture of biologic products, including monoclonal antibodies, bioconjugates, and other large molecule modalities.

The Biologics Process Engineering Team Leader leads the process engineering organization and influences across functional teams to support the process engineering agenda, business plan priorities, and compliance plan objectives.

In the project delivery and startup phase of the Lilly Medicine Foundry (startup expected 2025 to 2027), leadership roles will be fluid and dynamic as we endeavor to support project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity, and resilience as the site evolves from a design concept to a GMP clinical trial site.

**Key Responsibilities**

- Responsible for establishing a technically advanced biologics process engineering group. This is achieved through recruitment, supervision, coaching, succession planning, and establishing actionable development plans, inclusive of completing performance reviews and development planning.

- Provide process engineering work coordination and guidance to key functional groups and partners supporting biologics manufacturing operations, including upstream (cell culture/fermentation) and downstream (purification, filtration, formulation) unit operations.

- In coordination with the engineering function, set and reinforce standards for engineering work product and utilization of first principles. Partner within Engineering and across functional teams to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.

- Ensure appropriate process engineering support for biologics operations including facility fit assessments, process troubleshooting, scale-up/scale-down support, and continuous process improvements for biologic drug substance manufacturing.

- Oversee engineering-related technical issues, improvement initiatives, and technology upgrades specific to biologics unit operations (e.g., bioreactors, chromatography systems, TFF/UF-DF, sterile filtration, single-use systems). Review and approve engineering-related deviations and change controls.

- Ensure GMP compliance of facilities, processes, and documentation, maintaining the organization in a state of inspection readiness. Ensure all process engineering activities and documentation are performed in alignment with current data integrity requirements.

- Ensure technical review and approval for documents as appropriate, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing records, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, and biologics-specific documents such as process characterization reports and comparability assessments.

- Identify, track, and report key indicators of functional performance.

- Partner appropriately in site planning processes (capital and resource), representing the interests of the team with a view to the overall site picture and future biologics portfolio.

- Serves as System Owner for designated computer, automation, and bioprocess control systems (e.g., bioreactor SCADA, process chromatography systems).

- Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits, including BLA/IND-relevant inspections.

- Network globally to share best practices, control strategies, and process rationale to ensure harmonization and alignment between Lilly biologics manufacturing sites.

**Startup Phase Responsibilities (2025–2027)**

During the startup phase of the Lilly Medicine Foundry, leadership will be expected to be collaborative, inclusive, and support the broader team to:

- Build the biologics process engineering organization with the necessary capability, capacity, and culture to operate this facility to the highest standards of operational excellence.

- Develop and implement the systems and processes needed to run the site, leveraging existing Lilly biologics knowledge and practices where applicable, while also incorporating external experiences and learnings from the broader biopharmaceutical industry.

- Ensure regulatory compliance and operational excellence by supporting lean principles in their respective area.

- Support the project team as they deliver the facility to the site team by providing feedback and input on biologics-specific design requirements.

**Basic Requirements**

- Bachelor's degree in Engineering, Biochemical Engineering, Chemical Engineering, or a related science field.

- 5+ years of experience in a process engineering role supporting biologics drug substance manufacturing or development activities, preferably in a GMP manufacturing environment.

- Demonstrated experience with upstream and/or downstream biologics unit operations (bioreactors, chromatography, filtration, formulation).

**Additional Preferences**

- Experience leading a team of process engineers highly preferred

- Thorough understanding of bioprocess development and operations, regulatory requirements (FDA, ICH), cGMP, HSE regulations, and data integrity requirements as they apply to biologics manufacturing.

- Experience with single-use technology systems and associated engineering considerations.

- Familiarity with biologics regulatory submissions (IND, BLA, CTD modules) and process characterization/validation requirements.

- Capable of collaborating effectively within a team, making autonomous decisions, and influencing a diverse range of groups.

- Skilled at fostering teamwork within the department and showcasing essential interpersonal skills.

- Proficient in devising creative solutions to plant, divisional, and corporate issues, while leveraging insights from various functional areas.

- Experience with cell culture media/feed strategies, viral clearance requirements, and biologics-specific contamination control strategies is a plus.

**Other Information**

- Initial location at Parkwood West, Indianapolis.

- Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.

- Position is standard business hours with flexibility to support activities during startup, shutdowns, and weekends as required.

- Travel is possible but expected to be minimal.

- Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$123,000 - $180,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Senior Principal Engineer - Automation Engineering – Process, Lab & Enterprise Systems

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Organization and Position Overview**

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

**Responsibilities**

The Senior Principal Engineer - Automation Engineering will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. Process Automation is core to delivering a right first time facility start up and continued support of ongoing manufacturing operations into the future.

The Engineer is also responsible for the productivity and mentorship of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing at Foundry. Additionally, the Engineer as a key technical expert with partners to influence and implement within the process control organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives.

In the project delivery phase and startup phase of the project (startup expected 2025 to 2029), automation engineering roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.

The team's core focus it is split into the Foundry DeltaV- and Rockwell-controlled process PLC equipment serving the Lab and Admin building and the site's Laboratory analytical systems. The team provides administration and configuration support for the process PLC equipment serving the Lab/Admin building, the team manages the integration from analytical systems into them and handles recipe setup and maintenance.

**Key Objectives/Deliverables:**

- Technical Leadership
- Mentor process control team, including design, controls philosophy, implementation and commissioning
- Process control work implementation and coordination
- Develop and implement the Automation Engineering Project Plan.

**Operational Excellence**

- Technically lead and oversee the work of Site Area leads and System Integrator including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications.
- Lead/Participate in design reviews, attend equipment and software FATs
- Own the site-wide administration strategy for Laboratory and Analytical equipment, including user access, data management and integration to PI and other repositories/DCS, and backup/restore; supervise third-party execution of analytical system implementation and set configuration standards
- Partner with tech@Lilly on Empower, LIMS (LabVantage), MES and ELN integration touchpoints and provide design input
- Lead and mentor the Analytical Systems Support Engineers and Associate Engineer supporting this function
- Lead a team of automation engineers supporting commissioning
- Provide periodic status updates to Project Management
- Devising functional requirements and process control strategies for control systems in collaboration with Process Engineering
- DCS software design, coding/configuration and testing (sequence logic, graphics, batch software etc.)
- Automation Engineering including design, tuning and troubleshooting of control loops
- Implementing and supporting electronic systems (such as plant historians) used to capture process automation related production data
- Maintain the validated state of the site control systems in line with Lilly quality standards including the development and execution of validation strategies and associated documentation
- Automation support for capital projects including new product introductions
- Promoting the use of automation to improve productivity, operational efficiency and compliance
- Developing a 'network' of corporate contacts and leveraging corporate expertise when needed

**Organizational Capability**

- In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products.
- Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines.
- Possess a keen technical curiosity and has demonstrated strong problem-solving skills and a desire for continuous improvement
- Demonstrated ability to influence peers and business partners
- Good written and verbal communication skills for both technical and non-technical audiences
- Knowledge of GMP, regulatory requirements, computer system validation

**Basic Requirements:**

- Minimum B.S. in Engineering or Science and experience in Automation Engineering, preferably in major Pharmaceutical manufacturing handling Laboratory and Analytical systems and equipment, and Systems Integration and a minimum of 8+ years working experience in Biopharma engineering, operations, or manufacturing.
- Experience in commissioning, qualifying and supporting analytical and automation-controlled lab equipment such as cell counters, UHPLC/chromatography systems, mass spectrometers, single-use bioreactors, RX-10 lab reactor control systems, and Rockwell PLC-controlled autoclaves/parts washers.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Preferences:**

- Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS and Site Historian systems (DeltaV, Rockwell, Syncade, LabVantage, OSI PI).
- Experience in facilitating and driving decision-making at an organizational level.

**Other Information:**

- Current location Parkwood West-Indianapolis, IN.
- Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

\#WeAreLilly

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$66,000 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly