Manufacturing & Production

Eli Lilly and Company

Process 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.

Lilly is a fortune 500 company in operation for 150 years creating high-quality medicines for our patients. The new facility on the Kenosha County campus will be one of Lilly’s most technically advanced manufacturing sites. The facility will include high-speed manufacturing, robotics, advanced data collection and analytics that will result in safety improvements, increased productivity, and variability reduction for Device Assembly/Packaging lines. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.

**Responsibilities:**

As the **Process Engineer,**  you will be supporting and managing the Packaging crucial to Lilly's supply chain. This role will be part of the LKC Site Engineering organization responsible for the delivery of the lines and support of continuous operations by providing subject matter expertise in process control, improvements, project management, and technical leadership to the process team. This position will require the development of expertise in production processes, commissioning, qualification, and validation requirements and equipment specific code and/or control system technologies. Individuals who have passion to integrate, qualify, and start up complex Device Assembly/Packaging systems while serving as the technical bridge between OEM equipment, manufacturing control systems, MES, warehouse systems, and site operations are encouraged to apply.

**Key Objectives/Deliverables:**

- Partner with Corporate Automation, Global Device Assembly/Packaging & Robotics, Automation Integrators, and Global Facilities Delivery to design, install, and qualify the new LKC Packaging lines.
- Take overall responsibility for the safe design and safe operation of the equipment within the area.
- Lead or participate in qualification activities (including commissioning activities of new equipment or areas).
- Assist in the integration of these lines into the site data collection and SCADA layer.
- Lead activities through the full project lifecycle including design review, FAT, installation, SAT, qualification, and startup support.
- Assist for integration between Device Assembly/Packaging equipment and enterprise manufacturing systems including MES, warehouse management systems, scheduling systems, and site automation platforms.
- Review OEM electrical, controls, and safety designs to ensure compliance with Lilly standards and applicable industry standards (e.g., machine safety, electrical safety, and control panel requirements).
- Assist automation verification and qualification activities, including IV/OV testing, system integration testing, and startup troubleshooting.
- Support implementation and lifecycle management of Lilly manufacturing platforms such as Global Packaging Platform (GPP), GRIP, GPM, Global Scheduler, and MES integrations.
- Support manufacturing system interfaces including PLCs, HMI/SCADA systems, databases, servers, virtual environments, networks, and middleware platforms.
- Partner with Quality, Operations, Engineering, IT, OEMs, and global platform teams to resolve complex automation and integration challenges during project execution and commercial operations.
- Assist manufacturing system startup readiness activities including PSSR execution, safety verification, automation cutovers, and qualification support.
- Communicate effectively with cross functional team members in roles such as quality, logistics, and crafts personnel.
- Obtain technical expertise of equipment and processes in area of responsibility.
- Clear understanding of equipment flow chart, process flow document, critical process parameters, and equipment controls.
- Establish control charts & monitor/trend operating parameters to verify and optimize equipment performance.
- Lead troubleshooting efforts to resolve more difficult equipment and operational problems.
- Utilize formal problem-solving techniques, such as root cause analysis and causal factor charting, to resolve equipment deviations.
- Provide oversight and assist maintenance personnel and engineering techs that support the equipment.
- Evaluate all activities for impact on qualified state of equipment and utilize appropriate tools/processes as necessary (change control, hold, etc.).
- Responsible for system/component classification and maintenance strategy for equipment.
- Implement corrections, corrective actions, and countermeasures arising from CAPA’s.
- Participate in Periodic Reviews for equipment.
- Act as user representative for capital projects or local projects.
- Understand equipment reliability issues and performance KPIs.
- Identify and drive improvement opportunities (procedural changes, upgrades, projects, etc.) associated with equipment within the area.
- Plan and coordinate equipment planned downtime windows for equipment improvements and preventative maintenance.
- Compare equipment performance data with other manufacturing sites within the network to determine areas of opportunity.
- Establish & monitor/trend control systems as tool for verifying and optimizing equipment performance.
- Lead troubleshooting efforts to resolve more difficult equipment and operational problems.
- Utilize formal problem-solving techniques, including Root Cause Analysis, to resolve equipment issues.
- Provide oversight to Maintenance Tech/Engineering Tech(s) that support the area.
- Responsible for system/component classification and maintenance strategy for equipment.
- Drive continuous improvement initiatives by identifying root causes, implementing robust automation solutions, and improving reliability, quality, and operational performance.
- Mentor engineers and provide technical leadership across multiple manufacturing areas and project teams.
- Owner/SME of equipment, Device Assembly/Packaging processes, and maintenance programs associated with Lilly Global Quality Standards (GQS) and Engineering Best Practices/Functional Standards (EBP/EFS).
- Technically lead and delegate activities to a cross-functional technical team supporting the Device Assembly/Packaging lines on medium-large scale projects.
- Proficient and capable of understanding OSHA/regulatory (CFR) requirements and ensuring compliance.

**Requirements (Education, Experience, Training):**

- Bachelor’s degree in STEM
- 7+ years of experience as a process engineer in highly automated environment

**Preferred attributes but not required:**

- Technical leadership.
- Strong automation background.
- Strong learning mindset with curiosity, adaptability, and technical aptitude to rapidly acquire new skills and technologies.
- Proven experience delivering engineering projects in both greenfield and brownfield environments, including facility startup, commissioning, expansion, and retrofit initiatives.
- Ability to lead first-time processes and navigating a cross-functional team through ambiguity.
- Pharmaceutical cGMP experience and compliance OSHA and CFR knowledge.
- Project management skills.
- Adequate interpersonal and communications skills to be able to work effectively in a team-based environment.
- Strong knowledge of Studio 5000 and FactoryTalk View SE.
- Understanding of automated vision systems, and robotics.
- Ability to apply statistical thinking concepts to the analysis of manufacturing problems.
- Experience in utilizing root cause analysis techniques for the systematic solving of problems.

**Additional Information:**

- Schedule - 8-hour days - Monday through Friday, rotational on-call support will be required.
- Travel - Domestic and International travel may be required during startup phase (25-50%). Domestic and International travel may be required after Operation Readiness (5-10%).

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

Wisconsin

Process Automation Engineer – Packaging

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 is a fortune 500 company in operation for 150 years creating high-quality medicines for our patients. The new facility on the Kenosha County campus will be one of Lilly’s most technically advanced manufacturing sites. The facility will include high-speed manufacturing, robotics, advanced data collection and analytics that will result in safety improvements, increased productivity, and variability reduction for Packaging lines. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.

**Responsibilities:**

As the **Process Automation Engineer – Packaging,**  you will be supporting and managing the Packaging crucial to Lilly's supply chain. This role will be part of the LKC Site Engineering organization responsible for the delivery of the lines and support of continuous operations by providing subject matter expertise in process control, improvements, project management, and technical leadership to the process team. This position will require the development of expertise in production processes, commissioning, qualification, and validation requirements and equipment specific code and/or control system technologies. Individuals who have passion to architect, integrate, qualify, and start up complex packaging systems while serving as the technical bridge between OEM equipment, manufacturing control systems, MES, warehouse systems, and site operations are encouraged to apply.

**Key Objectives/Deliverables:**

- Partner with Corporate Automation, Global Packaging & Robotics, Automation Integrators, and Global Facilities Delivery to design, install, and qualify the new LKC packaging lines.
- Assist in the integration of these lines into the site data collection and SCADA layer.
- Lead automation activities through the full project lifecycle including design review, FAT, installation, SAT, qualification, and startup support.
- Serve as the technical owner for integration between packaging equipment and enterprise manufacturing systems including MES, warehouse management systems, scheduling systems, and site automation platforms.
- Review OEM electrical, controls, and safety designs to ensure compliance with Lilly standards and applicable industry standards (e.g., machine safety, electrical safety, and control panel requirements).
- Develop and execute automation verification and qualification activities, including IV/OV testing, system integration testing, and startup troubleshooting.
- Support implementation and lifecycle management of Lilly manufacturing platforms such as Global Packaging Platform (GPP), GRIP, GPM, Global Scheduler, and MES integrations.
- Design, troubleshoot, and support manufacturing system interfaces including PLCs, HMI/SCADA systems, databases, servers, virtual environments, networks, and middleware platforms.
- Partner with Quality, Operations, Engineering, IT, OEMs, and global platform teams to resolve complex automation and integration challenges during project execution and commercial operations.
- Lead manufacturing system startup readiness activities including PSSR execution, safety verification, automation cutovers, and qualification support.
- Drive continuous improvement initiatives by identifying root causes, implementing robust automation solutions, and improving reliability, quality, and operational performance.
- Mentor engineers and provide technical leadership across multiple manufacturing areas and project teams.
- Owner/SME of equipment, Packaging processes, and maintenance programs associated with Lilly Global Quality Standards (GQS) and Engineering Best Practices/Functional Standards (EBP/EFS).
- Technically lead and delegate activities to a cross-functional technical team supporting the packaging lines on medium-large scale projects.
- Proficient and capable of understanding OSHA/regulatory (CFR) requirements and ensuring compliance.
- Clear understanding of equipment flow chart, process flow document, critical quality attributes, and equipment controls.
- Establish control charts & monitor/trend operating parameters to verify and optimize equipment performance/KPIs.
- Provide tertiary support in troubleshooting efforts to resolve more difficult equipment and operational problems.
- Utilize formal problem-solving techniques, such as root cause analysis and causal factor charting, to resolve equipment deviations.
- Responsible for system/component classification and maintenance strategy for equipment.
- Identify and gain alignment on corrective actions and countermeasures arising from CAPA’s.
- Accountable for Periodic Reviews for equipment.
- Identify and drive improvement opportunities (procedural changes, upgrades, projects, etc.) associated with equipment within the area.

**Requirements (Education, Experience, Training):**

- Bachelor’s degree in STEM
- 7+ years of experience as a process engineer with automation expertise

**Preferred attributes but not required:**

- Technical leadership.
- Strong learning mindset with curiosity, adaptability, and technical aptitude to rapidly acquire new skills and technologies.
- Proven experience delivering engineering projects in both greenfield and brownfield environments, including facility startup, commissioning, expansion, and retrofit initiatives.
- Ability to lead first-time processes and navigating a cross-functional team through ambiguity.
- Pharmaceutical cGMP experience and compliance OSHA and CFR knowledge.
- Project management skills.
- Adequate interpersonal and communications skills to be able to work effectively in a team-based environment.
- Strong knowledge of Studio 5000 and FactoryTalk View SE.
- Understanding of automated vision systems, and robotics.
- Ability to apply statistical thinking concepts to the analysis of manufacturing problems.
- Experience in utilizing root cause analysis techniques for the systematic solving of problems.

**Additional Information:**

- Schedule - 8-hour days - Monday through Friday, rotational on-call support will be required.
- Travel - Domestic and International travel may be required during build-up phase (25-50%). Domestic and International travel may be required after Operation Readiness (5-10%).

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

Associate Director – Parenteral Engineering, Operations Expansion

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.

Eli Lilly and Company is seeking an Associate Director – Parenteral Engineering, Operations Expansion to lead the engineering and technical aspects of parenteral manufacturing expansion projects. This role will drive the design, implementation, and optimization of new and upgraded parenteral facilities, ensuring compliance with cGMP regulations and Lilly’s quality standards.

Job Responsibilities:

- Lead and manage the engineering design, development, and execution of parenteral manufacturing expansion projects, from conceptual design through commissioning and qualification.
- Oversee the selection, procurement, installation, and validation of new parenteral manufacturing equipment and systems, including aseptic filling lines, lyophilizers, isolators, and associated utilities.
- Collaborate with cross-functional teams including Manufacturing, Quality, Regulatory, and Project Management to define project scope, technical requirements, and deliverable timelines.
- Develop and implement engineering strategies to optimize manufacturing processes, improve efficiency, reduce costs, and enhance product quality for parenteral products.
- Ensure all engineering activities comply with internal Lilly standards, industry best practices, and applicable regulatory requirements (e.g., FDA, EMA).
- Manage external engineering firms, vendors, and contractors, ensuring adherence to project specifications, budget, and schedule.
- Conduct technical risk assessments and develop mitigation strategies for complex engineering challenges in a sterile manufacturing environment.
- Provide technical expertise and mentorship to junior engineers and project team members.
- Prepare and present project updates, technical reports, and proposals to senior leadership.
- Drive continuous improvement initiatives in parenteral engineering and operations.

Basic Requirements:

- Bachelor's degree in chemical engineering, Mechanical Engineering, Biomedical Engineering, or a related scientific discipline. Master's degree preferred.
- Minimum of 10 years of experience in pharmaceutical manufacturing, with at least 5 years specifically in parenteral drug product manufacturing and aseptic processing.
- Demonstrated experience leading large-scale capital projects for manufacturing expansions or new facility builds within the pharmaceutical industry.
- Strong understanding of cGMP regulations, FDA/EMA guidelines, and industry standards related to aseptic manufacturing, sterile product fill/finish, and facility design.
- Expertise in the design, qualification, and operation of parenteral manufacturing equipment (e.g., vial filling lines, pre-filled syringe lines, lyophilizers, isolators, cleanrooms, WFI/pure steam systems).
- Proven ability to manage complex projects, budgets, and schedules in a fast-paced environment.
- Excellent leadership, communication, and interpersonal skills, with the ability to effectively collaborate with diverse teams and stakeholders.
- Strong analytical and problem-solving abilities.
- Experience with process optimization and lean manufacturing principles in a pharmaceutical context.
- Ability to travel domestically and internationally as required for project needs.

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 Director – Technical Services/Manufacturing Science (TS/MS)

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 unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 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.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

**Role Description:**

The Senior Director of Technical Services/Manufacturing Science (TS/MS) for Small Molecule or Peptides provides strategic and operational leadership for the Lebanon LP1 site. This role ensures safe, timely, and compliant startup, process validation, and inspection readiness for new and existing products. The position drives technical excellence, fosters innovation, and develops future technical leaders to support global manufacturing objectives.

**Responsibilities:**

- Key participant in developing the strategic direction for the site on both the medium and the long term.
- Lead all aspects of TS/MS for small molecule or peptide operations, including new product introduction and optimization.
- Develop and execute strategic and operational plans for TSMS aligned with site and corporate goals.
- Ensure validated state of all processes and compliance with cGMP and regulatory requirements.
- Build strong technical partnerships with Synthetic Molecule Design and Development (SMDD), Global TSMS, and other global functions.
- Oversee preparation and timely completion of technical documentation and reports.
- Provide leadership in technical problem-solving, risk management, and continuous improvement initiatives.
- Coach and mentor team members, ensuring resource allocation and capability development.
- Represent TS/MS in cross-functional governance and strategic decision-making forums.

**Basic Requirements:**

Education Level: PhD degree in Chemistry or related field

Experience: 15+ years in pharmaceutical development and manufacturing with leadership in TS/MS or similar department. Large scale manufacturing experience preferred.

**Additional Skills/Preferences:**

- Proven ability to lead large technical organizations and manage complex projects.
- Expertise in process validation, technology transfer, and regulatory compliance.
- Strong strategic thinking and business acumen.
- Excellent communication and stakeholder engagement skills.
- Ability to manage changing priorities within tight timelines.

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

$168,000 - $246,400

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

Automation Engineering, Sr. Engineer – Pharmaceutical Manufacturing - 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.

The 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 Senior Principal 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 202 8 ), 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. 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 and DeltaV application software reviews, attend equipment and software FATs • 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 and SCADA software design, coding/ configuration and testing (sequence logic, graphics, batch software etc.) • Perform automation engineering activities including design, tuning and troubleshooting of control loops • Implement and support electronic systems (such as plant historians, applications and software integration) 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 and experience in Automation Engineering, preferably in Small Molecule API, Biologics and/or Cell Therapy manufacturing. • 2 + years working experience in Biopharma engineering, operations, or manufacturing. • 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, PLC and MES systems ( DeltaV , Rockwell, Syncade , etc ). • Experience in facilitating and driving decision-making at an organizational level.

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

Scientist/Engineer – Technical Operations - 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.

**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.

The Lilly Medicine Foundry Manufacturing Scientist/Engineer – Technical Operations supports and potentially executes on shift operations activities to ensure effective and consistent execution on the operation floor. This role provides on floor operation execution working directly with operators, supports batch readiness and release, and works cross-functionally to provide technical and operational oversight to routine operations. The Scientist/Engineer – Technical Operations becomes an expert in their assigned area, Small Molecule, Hybrid, or Biologics, and serves as a key integrator with Process Engineering, Process Translation and Execution (PTE), and Product Research and Development (PRD) in introducing new processes into the plant. The Scientist/Engineer – Technical Operations represents operations leading detailed planning of process changeover, and the new product introduction process.

In the pre-startup phase, the Scientist/Engineer – Technical Operations will contribute heavily to Operational Readiness activities for the new facility supporting technical processes, tech transfer, operational readiness, delivery of trainings, procedures, and workflows. Initially, the Scientist/Engineer – Technical Operations will be responsible for supporting equipment qualification and site acceptance tests (SAT) while developing standard operating procedures and operator training plans.

Upon completion of the project phase, the Scientist/Engineer – Technical Operations will provide technical oversight and ownership for the operations team providing on the floor training and process support, and leading incident investigations. This role plays a key technical role working collaboratively with the Process Translation and Execution (PTE), Processing Engineering (PE) and Product Research and Development (PRD) to prepare for effective delivery of our products. This role provides key technical input and participates in pre-startup activities such as Process Hazard Reviews (PHRs), development batch instructions, and support on the floor operations. The Scientist/Engineer could participate in performing routine manufacturing activities and may be on shift as needed in future operations. The Scientist/Engineer – Technical Operations ensures a safety-first, quality-always approach while managing a production process that encompasses diverse unit operations and manufacturing skills. This role may require domestic and international travel to collaborate, train, and learn from sites that currently produce APIs.

Key Responsibilities:

- Provide on the floor shift support for the operations staff for technical, training, and process support and at times execute production activities.
- Leverage problem solving skills to evaluate process & protocols, deviations real-time and provide assessments to cross functional process teams.
- Apply independent judgement and discretion to execute equipment commissioning and qualification testing under the guidance of the C&Q
- Conduct and appropriately document production via adherence to digital manufacturing batch records and affiliated SOPs.
- Adhere to all applicable procedures, cGLP, cGMPs, company policies, and any other quality or regulatory requirements.
- Ensure improvement opportunities from Operators are appropriately documented and assessed
- Work with area maintenance to schedule work orders for corrective maintenance.
- Lead Safety and Quality Investigations and author investigation reports.
- Cross-functional collaboration to enable Foundry technology transfers.
- Serve as a key resource for operational improvement projects and other initiatives.
- Partner with functional groups to prepare for process campaigns creating project plans for changeover execution, including optimized approaches for cleandown, piping, maintenance, and equipment setup execution. Coordinate and oversee project execution to meet desired timelines.
- Work cross-functionally with PE, PTE, PRD, HSE, and Quality Assurance to ensure processes are transferred and executed successfully in the Foundry.
- Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards and represent operations in Process Hazard Review (PHR) meetings and other HSE-related venues.
- Promote continuous improvement of area changeover workflows to make changeovers easier or more efficient.
- Collaborate in a fast paced team environment

Basic Requirements:

- Bachelor’s or Associate's Degree in science, engineering, or technical field or HS Diploma/GED with 5+ years of directly applicable manufacturing experience pharmaceutical operations (Small Molecule, Biologics, or Mixed Modalities) including on the operations, incident investigations (safety and quality), authoring procedures/instructions, and process hazard reviews.
- 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 Pharmaceutical Product Research and Development
- Experience providing technical and/or coordination support toward cleaning, changeover, and/or maintenance activities in a GMP production environment
- Formal project management training considered a plus
- Demonstrated leadership and influencing experience
- Previous experience in facility or area start-up environments.
- A solid understanding of FDA guidelines and cGMP requirements.
- Strong organizational skills with the ability to handle and prioritize multiple requests.
- Knowledge of lean manufacturing principles.
- Flexibility to troubleshoot and triage challenges effectively.
- The ability to understand technical nomenclature and language, as well as work with mathematical formulas.
- Ability to effectively communicate (electronically, written and verbal).

**Other Information:**

- Initial location at Lilly Technology Center, Indianapolis, or Parkwood West, Carmel, Indiana
- Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
- Travel Percentage: 5%
- Position requires on-site presence on a M-F schedule, with flexibility to support operations activities in a 24/7 hour manufacturing environment during nights and weekends as needed.

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

Pharmaceutical Manufacturing Operator

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.

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.

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply.

This is an exciting opportunity to help start up a state-of-the-art facility and build a manufacturing supply chain from ground-up.

The Manufacturing Operator will be responsible for performing routine manufacturing activities across GMP manufacturing areas, including: Cell Culture, Downstream Purification, and Fill & Finish at the Lebanon Advanced Therapies, LP2 site.

Initially, the Operator will be responsible for supporting execution of equipment qualification, developing site operations procedures and setting up production areas. During this initial project delivery/startup phase of the project, roles will be fluid and dynamic. Once the plant is operational, the Manufacturing Operator will be responsible for execution of production activities on their shift under the leadership of the shift supervisor.

**As a Manufacturing Operator, your responsibilities will include:**

- Work in a cleanroom environment to produce advanced therapies in a safe and quality manner.
- Coordinate production activities with Quality Control, Quality Assurance, and Plant Maintenance to facilitate on-time release of advanced therapies.
- Participate in equipment commissioning and qualification testing and process validation activities in collaboration with other departments.
- Safely work with BSL-2 materials, following site biologics safety program.
- Conduct and appropriately document production of advanced Therapies via strict adherence to digital manufacturing batch records and affiliated SOPs.
- Utilize and monitor manufacturing equipment to ensure performance and safety standards are met.
- Collaborate with maintenance technicians, equipment manufacturers, and quality assurance to ensure that all production equipment is in good working order and is validated for use.
- Provide verbal and written reports to supervisors and other teams in a clear and concise manner.
- Maintain accurate and complete electronic records and logbooks as per cGLP and/or cGMP, as appropriate.
- Adhere to all applicable procedures, cGLP, cGMPs, company policies, and any other quality or regulatory requirements.
- Compliance with cleanroom gowning requirements required for completing specific work in drug substance and drug product.

- Work well in a fast-paced team environment.

**Minimum Requirements:**

- High School diploma or equivalent
- Direct manufacturing experience with automatic, manual, and semi-automated equipment, following operational procedures.
- 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:**

- 3+ years pharmaceutical cleanroom experience or equivalent comparable manufacturing experience
- Drug Substance experience; hands-on expertise working with bioreactors, sums, TFFs, purification, and similar processes
- Technical problem-solving skills.
- Good communications skills (both oral and written).
- Requires learning and understanding Good Manufacturing Practices and strict adherence to GMP regulations.
- Will be expected to adhere to all safety and environmental guidelines and to promote safety and environmental compliance in all areas.
- Good organization skills.
- Ability to work with and learn new digital systems
- Ability to demonstrate attention to detail

**Other Information:**

- During the start-up phase of the project, the shift will be primarily day shift. As the site nears normal operation, shift work will be required. Anticipated to be 2-2-3 12 hour shift.
- Ability to maintain focus on a complex task for 4-6 hours at a time.
- Adaptable to work in a fast-paced and evolving environment.
- Maintain clear, consistent, and constant verbal communication with one or more team members during performance of duties.
- Some overtime required.

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

$17.30 - $34.38

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

Visual Inspection Scientist - Advanced Therapies Manufacturing

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 opened a cutting edge manufacturing facility dedicated to genetic medicines at Lebanon, Indiana. This facility is Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It includes next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply.

**Position Description:**

Visual Inspection Scientist – Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support to achieve the reliable and compliant manufacture of gene therapy drug product to predetermined global quality standards via a detailed set of manufacturing instructions and procedures. In this role, the successful candidate provides day-to-day technical support to the visual inspection program, supporting inspection qualification, defect classification, and process monitoring while working cross-functionally with Operations, Quality Assurance, and Engineering. This person interacts daily with a wide variety of stakeholders internally and externally.

The mission of TS/MS is to provide scientific leadership and technical support for manufacturing to make medicine today and tomorrow.

**Key Objectives/Deliverables**

- Understand the scientific and quality principles that govern the visual inspection of drug products, including how the product, equipment, aseptic processes, and container closure systems influence inspection outcomes and defect presentation.
- Provide day-to-day technical support to the visual inspection process so that inspection is performed reliably, consistently, and in compliance with applicable procedures and quality standards.
- Support the qualification and ongoing performance of inspection personnel and equipment, including inspector qualification, defect classification, and review of inspection results, escalating complex questions to Quality or senior TS/MS as needed.
- Support the maintenance of visual inspection tools and materials, such as test kits, practice kits, and defect libraries, in partnership with Quality Assurance.
- Help monitor visual inspection performance and quality metrics, identify trends, and support timely and appropriate responses to process variability.
- Prepare, review, and provide technical support for visual-inspection-related studies and documentation, such as procedures, work instructions, deviation investigations, change controls, and monitoring reports.
- Participate in continuous improvement, deviation investigations, and cross-functional projects related to visual inspection, and continue to develop visual inspection knowledge and technical capability over time.
- Train, coach, and mentor operators, statistical sorters, and inspectors on inspection technique and defect classification, and support the visual inspection practice, job shadowing, and training program.
- While primarily focused on visual inspection, provide technical support to other areas of the TS/MS and manufacturing organization and perform other related duties as assigned, based on site priorities and business needs.

**Basic Requirements:**

- Bachelor's degree in scientific disciplines of Biochemistry, Chemistry, Microbiology, Pharmacy, Engineering or related scientific field.
- 3+ years of experience in manufacturing, preferably within pharmaceutical manufacturing environment.
- Must pass a vision exam and be free of color blindness
- Must be able to perform tasks requiring near‑vision clarity equivalent to 20/20 at close range, with or without corrective lenses
- 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:**

- Clear understanding of current Good Manufacturing Practices (cGMPs).
- Computer skills
- Teamwork and interpersonal skills
- Preferred experience in visual inspection of pharmaceutical products, including familiarity with defect classification, inspection qualification, or statistical sort.
- Ability to influence and communicate to diverse groups on, technical or business issues within the site and function.
- Ability to train, coach, and mentor operators, statistical sorters, and inspectors on visual inspection technique and defect classification.
- Experience in statistics and stackable tolerance analysis.
- Builds relationships with internal and external customers and partners.
- Proficiency in delivering complex tasks and/or tasks that are cross-functional.
- Ability to manage multiple tasks and priorities.
- Demonstrated Project Management skills and ability to coordinate complex projects.
- Strong analytical, quantitative problem solving and decision-making skills.
- Strategic thinking and ability to balance short term needs with long term business evolution.

**Additional Information:**

- Responsible for maintaining a safe work environment at all times.
- Occasional off-shift availability may be needed to respond to operational issues; this is expected to be limited and, where possible, arranged in advance.
- Minimal travel required.

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

$67,500 - $173,800

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

Principal Associate QA - Labeling and Packaging

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:**

The Labeling and Packaging Quality Assurance Associate provides quality oversight for labeling, packaging, ultra-low temperature storage, and distribution operations at the LP2 Advanced Therapies site. This position supports the start-up of labeling and packaging capability for new drug products, provides real-time quality support on the manufacturing floor during operations, and supports validation of labeling and packaging for multiple new ultra-low temperature products. The role partners with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and external partners to ensure labeling and packaging operations meet cGMP requirements and regulatory commitments. This position also provides white-glove, end-user support for post-distribution activities to ensure patient needs are met.

**Responsibilities:**

- Lead quality assurance support for the start-up of labeling and packaging operations for new drug products, including process mapping, procedure and batch record development, artwork and label proof approval, and first GMP execution.

- Provide on-the-floor quality oversight during labeling and packaging operations, including line clearance, label reconciliation, in-process checks, batch record review, and real-time resolution of floor questions.

- Support validation of labeling and packaging for multiple new ultra-low temperature drug products, including protocol development, execution, and reporting for equipment qualification, and PPQ activities.

- Provide quality support for storage and distribution of drug product, including ultra-low temperature and cryogenic storage, cold-chain excursion review, shipping lane and container qualification, and release-to-ship processes. Provide white-glove, end-user support for post-distribution activities to ensure patient needs are met.

- Initiate and investigate deviations, change controls, and CAPAs associated with labeling, packaging, storage, and distribution, and maintain inspection readiness of the area as a subject matter expert.

**Basic Qualifications:**

- Bachelor’s degree in a scientific, engineering, or other technical discipline.
- 2+ years of experience in GMP pharmaceutical, biologics, or medical device operations, including experience in quality assurance, manufacturing, packaging, or validation.
- 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:**

- Previous experience in pharmaceutical labeling and packaging operations, including line clearance, label reconciliation, and serialization.
- Previous experience with cell therapy, gene therapy, vaccine, or other products requiring ultra-low temperature or cryogenic handling and cold-chain distribution.
- Prior work with new product introduction, technology transfer, or start-up of a new manufacturing capability.
- Proven ability to author and execute validation protocols (IQ/OQ/PQ, EMPQ, PPQ) and temperature mapping studies.
- Proficient in electronic quality and manufacturing systems, including Veeva Vault, Kneat, MES/electronic batch records, and LIMS.
- Proven ability to make risk-based quality decisions in real time and to escalate issues clearly under schedule pressure.

**Additional Information:**

- Travel Percentage (%): **Up to 15%**
- Shift Information: Day shift, with off-shift and weekend support required during packaging campaigns, validation runs, and start-up activities. The position is on-site and requires regular presence on the manufacturing floor and in cold-chain warehouse areas.

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

Lead Operator, Hybrid Operations - Lilly Medicine Foundry

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.

**Job Position Overview:**

The Lilly Medicine Foundry Manufacturing Lead Operator actively supports start-up activities to bring manufacturing equipment into service. The Lead Operator becomes an expert in their assigned area and educates the team on the proper operation of the facility. This role requires domestic and international travel to collaborate, train, and learn from sites that currently produce APIs.

Upon completion of the project phase, the Lead Operator provides on-the-floor, tactical leadership for production of API molecules. The Lead Operator ensures a safety-first, quality-always approach while managing a production process that encompasses diverse unit operations and manufacturing skills.

**Responsibilities:**

This role ensures the supply of our medicines by supporting the team, following instructions, assisting with troubleshooting, collaborating cross-functionally, and upholding our safety-first, quality-always mindset. Lead Operators will support daily activities to meet production plans by:

- Responsible to help enforce adherence to compliance requirements (safety, quality, and environmental) and appropriately escalating any adverse events.
- Operating processes and equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions to meet production schedule.
- Provide on-the-floor leadership to make tactical day-to-day decisions and ensure proper prioritization of operations resources throughout the shift.
- Ensure completion of daily monitoring, testing, and cleaning duties to ensure equipment and systems are in good operating condition and maintained per local and corporate regulatory requirements.
- Serve as a cultural leader for site safety culture, promoting compliant operations and positive safety behaviors. Lead by example and promote accountability at all levels.
- Provide technical leadership for troubleshooting and reaction to process upsets, integrating operator input and escalating as appropriate.
- Follow all applicable procedures for safety event reporting and documentation. This includes following appropriate spill response procedures, escalation of issues, and initiating Emergency Response procedures as needed.
- Ensure adequate communication at shift passovers and participate in daily shift huddles/meetings to understand and set expectations for daily operational goals.
- Ensure all area personnel follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.
- Partner with area management and supervision to understand Foundry strategy and future production needs. Represent and support this strategy in conversations with shift members.
- Actively participating in assigned building and area operations such as safety audits, procedure coordination, housekeeping, and continuous improvement projects.
- Using specified company-supplied personal protective equipment (PPE) (e.g., hair and beard coverings, lab coats or gowns, safety shoes, safety glasses, hard hats, etc.) as required.

**Basic Requirements:**

- HS Diploma/GED
- 3+ years of directly applicable manufacturing experience, GMP and/or chemical processing strongly preferred.
- 2 years of direct leadership/supervisory experience required.
- API experienced required.
- 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:**

- Previous experience in facility or area start-up environments.
- Previous experience in a pharmaceutical or chemical manufacturing operation involving PSM-regulated or hazardous chemicals.
- A solid understanding of FDA guidelines and cGMP requirements.
- Strong organizational skills with the ability to handle and prioritize multiple requests.
- Knowledge of lean manufacturing principles.
- Flexibility to troubleshoot and triage challenges effectively.
- The ability to understand technical nomenclature and language, as well as work with mathematical formulas.
- Ability to effectively communicate (electronically, written and verbal).
- Basic computer skills (desktop software) are required.

**Additional Information:**

- Position Location: US: Lebanon IN Lilly Medicine Foundry Operations initial location in Indianapolis, IN during pre-startup phase
- Travel Percentage: 5%
- Must be able to work a 12-hour rotating shift
- May be required to provide support outside of normal working hours including nights, 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 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

$25.96 - $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

Associate Director - Joint Process Team Lead

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:**

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply.

This is an exciting opportunity to help start up a state-of-the-art facility and build a manufacturing supply chain from ground-up. The LP2-EM Joint Process Team Leader is focused on relationship building internally and externally, leading the cross functional team and project prioritization and management for assigned relationships within Lebanon 2 External Manufacturing (LP2-ExM).

**Key Objectives:**

- Lead cross-functional Joint Process Team (JPT), between Lilly and contract manufacturer (CM), to develop and implement strategically aligned Quality and Supply Plans as well as the Technical Agenda for the CM.
- Successfully facilitate and champion quality, technical, and regulatory compliance to ensure continuous supply to the marketplace.
- Manage production, batch release and shipment schedules to ensure appropriate resources to meet objectives.
- Resolve supply chain issues and provide internal notification to management or joint Lilly/CM Steering Team as necessary.
- Accountable for the metrics that align with Global Contract Manufacturing Standards (GCMS) to monitor performance at the CMs, and to review these at API external manufacturing lead team meetings.
- Serve as liaison to communicate status and issues to various management levels in operations, quality, marketing, and manufacturing networks.
- Author Manufacturing Responsibilities Document (MRD) defining each party’s roles and responsibilities aligned with the contract and Quality Agreement.
- Ensure that the MRD and contracts are being adhered to by Lilly and the CM.
- Make regular visits to CM to increase awareness of operations and maintain a strong working relationship.
- Manage conflict and problem resolution.
- Facilitate Lilly/CM Steering Team meeting agendas with issues from the JPT meetings requiring Steering Team action. Present and document the decisions in Steering Team minutes.
- Meet regularly with customers (Lilly plant sites or Lilly affiliates) to ensure supply goals are met, review performance metrics and improve customer service.
- Evaluate and manage efficiencies with product supply chains. Work with Tech Service/QC/Engineering/QA Representatives and 6 Sigma on continuous improvement projects.
- Accountable for on time delivery of commitments to supply plan, quality plan, and technical agenda.
- Deliver all product / projects to comply with GQS, GCMS, and applicable internal SOP’s.
- Other tasks may include assisting Tech Service and QA personnel to ensure timely completion of APR, AR, MR as necessary.

**Basic Requirements:**

- Bachelor’s degree or equivalent in Chemical Engineering, Mechanical Engineering, Chemistry/Biochemistry or related science.
- 5+ years of experience in pharmaceutical manufacturing, technical support, quality assurance, and/or quality engineering.

**Additional Preferences:**

- Ability to represent Eli Lilly and Company in a positive, professional, and ethical manner to both internal (Affiliate) and third-party contract manufacturers.
- Strong leadership and interpersonal skills, ability to build effective relationships, influence and achieve results through people.
- Self-motivated with ability to react quickly to changing requirements and processes.
- Demonstrated experience aligning with, delivery of or assuring cGMP compliance of a production operation.
- Proficiency in Word/Excel/PowerPoint and knowledge of Lilly-based systems (i.e., Trackwise, SAP, Veeva Vault)
- Project management skills including the ability to lead teams to produce quality deliverables within established time frames.
- Proficiency in Microsoft Project.
- Experience with contracts and relationships with third party suppliers.
- Establish technical, quality, and business networks.
- Travel will be required ( 20%)

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

$117,000 - $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

Drug Substance Manufacturing Scientist - Advanced Therapies Manufacturing

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 opened a cutting edge manufacturing facility dedicated to genetic medicines at Lebanon, Indiana. This facility is Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It includes next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply.

**Position Description:**

Drug Substance Manufacturing Scientist - Advanced Therapies Manufacturing role provides technical support for the reliable and compliant manufacture of gene therapy drug substance at external contract manufacturing organizations (CMOs) and, when needed, at LP2, in accordance with global quality standards. This role focuses specifically on drug substance operations — upstream cell culture and bioreactor processes, and downstream purification via chromatography, tangential flow filtration (TFF), and viral filtration.

The role requires daily interaction with external partners, internal process teams, and site management, and will lead technology transfer, process validation, process stewardship, and process monitoring activities. A strong understanding of manufacturing principles is required to ensure consistent standards are applied across internal and external manufacturing sites. The role requires cGMP knowledge, familiarity with applicable global regulatory manufacturing guidance, and the ability to work cross-functionally to deliver technical objectives.

**Key Objectives/Deliverables**

- Maintain in-depth knowledge of the drug substance process and the control strategy for gene therapy products, including cell culture, bioreactor operation, chromatography, TFF, and viral filtration.
- Provide technical oversight for drug substance manufacturing activities, including technology transfer, process validation, and frontline troubleshooting.
- Lead resolution of technical issues related to control strategy and manufacturing performance.
- Build and maintain working relationships with CMO partners and internal technical organizations.
- Ensure processes are properly characterized, documented, and justified, including alignment of Proven Acceptable Ranges (PAR) and Normal Operating Ranges (NOR) with demonstrated process capability.
- Monitor processes to confirm they remain compliant, capable, in control, and in a validated or qualified state. Identify early signals of process weakness and proactively resolve or escalate.
- Initiate deviation records and drive root cause investigations, ensuring on-time closure with appropriate CAPAs and effectiveness checks.
- Provide technical input to regulatory submissions; author and review annual reports to regulatory agencies.
- Prepare, review, and approve technical documents, including change controls, validation protocols and summary reports, batch records, process description documents, and annual reports.
- Maintain a safe working environment through compliance with safety standards and active participation in safety initiatives.

**Basic Requirements:**

- B.S. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or related quantitative field
- 3+ years of demonstrated experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS (MSAT), or Engineering functions
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide sponsorship 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 visa categories.

**Additional Preferences:**

- Experience with AAV or viral vector gene therapy drug substance manufacturing
- Hands-on or technical oversight experience with chromatography, TFF, or viral filtration purification processes
- Knowledge of applicable regulatory requirements for gene therapy manufacturing
- Experience with data trending and analytics to support process capability assessments (e.g., PAR/NOR alignment)
- Demonstrated project management skills with the ability to coordinate complex, cross-functional initiatives
- Strong communication skills, with the ability to influence diverse technical and business audiences

**Additional Information:**

- Off-hours support may be needed, by request.
- Required to respond, off shift, to operational issues.
- Minimal travel required.

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

$67,500 - $173,800

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

Mixed Modality (Peptide Upstream) Scientist - Process Translation and Execution

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 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, Lebanon, Indiana. 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 Process Translation and Execution (PTE) team translates API/DS process knowledge into clinical supply readiness, oversees technology transfer, implements phase-appropriate control strategies, and ensures right-first-time clinical manufacturing for a variety of modalities, including synthetic molecules, biologics, peptides, oligonucleotide, and bioconjugates (ADC, ARC, etc.) Through cross-functional collaboration, PTE influences process design, revolutionizes clinical manufacturing, builds capabilities in emerging technologies and aligns with corporate and Lilly Research Labs (LRL) goals, drives scientific excellence and innovation to accelerate manufacturing advancements and propels the site toward long-term business success.

In the Foundry Construction and Project Delivery/Startup Phase (2025 to 2028), roles will be ﬂuid and dynamic as we build a new organization, design and implement the necessary systems and business processes required to enable operational readiness, support the project delivery, and build the site culture. Success will require significant collaboration, creativity, and resilience as the Lilly Medicine Foundry transitions from design to startup and ultimately to steady-state operations and continuous improvement. This period presents a unique opportunity for learning, growth, and making a lasting impact.

We are seeking passionate and agile chemists to join the PTE team and help bring the Lilly Medicine Foundry’s vision to life.

**Responsibilities**

In this role, the Mixed Modality (Peptide Upstream) Scientist will be responsible with synthetically evaluating and facilitating the transfer of peptide upstream manufacturing processes, under appropriate supervisory guidance, from development laboratories to pilot plant operations (including kilo-scale and isolator production environments). This enables the successful transition to early-phase cGMP manufacturing of grams to kilogram quantities of API required for clinical trial supply.

- Perform synthetic peptide chemistry and assess synthetic routes from early phase process research and development labs
- Familiarity with performing peptide upstream procedures, such as SPPS and Cleavage & Precipitation.
- Evaluate the safety of the incoming procedures in collaboration with the safety group and process engineering.
- Ordering and staging chemicals.
- Obtain reference materials and participate in setting up analytical methods.
- Reprocess and analyze analytical data to make fact-based decisions.
- Efficient with summarizing and presenting chemistry and challenges.
- Perform familiarization executions to ensure plant readiness of process steps including SPPS and Cleavage & Precipitation at the Lilly Medicine Foundry.
- Perform use-tests of key raw materials and document Definitive Lab Trials of processes to confirm plant readiness.
- Maintain a well-organized and detailed lab notebook with accurate descriptions of the chemistry, observations, and organized analytical data to enable the preparation of technical packages/technical transfers and accurate replication in receiving labs.
- [Documentation:](<https://www.google.com/search?sca_esv=07cdbffa48f41bdb&cs=0&sxsrf=AE3TifPMvTaonOh9bWGLSZVCcp5Ku-ESCA%3A1761067824732&q=Documentation&sa=X&ved=2ahUKEwig2-Dw6LWQAxUoE0QIHS7LMXYQxccNegQIPBAD&mstk=AUtExfAvUVYFxKXw3PacmOn7gh4tr0v5R8Ec1sft--3jq1e2vqpabpJQYeAdD7_0LQg4Z_GqkAiJELV3A45HTgw7X82iYYgxSjQ9NTR6GsdZupp9g9dIPjSj0vyIA4lmVyueaOsDGGprrqJLfFE5z_m8WkPP6JVJaOoUjHX8V5MZW-IITWE&csui=3>)Author, review technical documents, including tech transfer plan, standard operating procedures (SOPs), batch records, campaign summary reports, and deviation reports.
- Process improvement: Apply scientific knowledge to identify areas for improvement and implement new technologies or procedures.
- Contribute to process troubleshooting and investigations by supporting process deviations, quality events, and non-conformances. Collaborate with teams to perform root cause analysis (RCA) and develop effective corrective and preventive actions (CAPAs)

**Basic Requirements:**

- B.S. or M.S. in chemistry, chemical engineering, or related field.
- 3+ years of experience in peptide chemistry and/or manufacturing environments involving synthetic peptide API or drug substance. Solid phase peptide synthesis is preferred.
- 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:**

- Working knowledge of peptide chemistry and mechanisms and application to reaction improvement and optimization.
- Experience with synthetic chemistry techniques used for developing and scaling-up chemical reactions. Experience using process chemistry concepts is a plus.
- Proficiency with the synthesis of peptide crude via solid phase peptide synthesis and cleavage & deprotection.
- Comfortable working with larger sized glass equipment.
- Highly motivated, able to learn rapidly, and demonstrates strong attention to detail.
- Has experience creating batch records and conducting scale-up experiments according to those records.
- Ability to prioritize multiple activities and manage ambiguity.
- Experience with a variety of analytical techniques: HPLC/UPLC, LC-MS, GC, NMR, etc.
- Process quantification and acquiring mass balance for products and by-products.
- Demonstrated ability to drive projects and accept change.
- Communication skills: Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams
- Familiarity with peptide downstream purification, TFF, lyophilization and understanding of precipitation and safe handling of solids/dry end processing.
- Problem-solving skills: Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.
- Ability to work cross-functionally across disciplines and levels with engineers, analytical chemists, chemical technicians, safety and quality representatives.

**Other Information:**

- Initial location at Lilly Technology Center, Indianapolis and/or Carmel, IN
- Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
- Limited domestic and international travel (\< 5%) may be required for this role
- Role requires ability to work in manufacturing and laboratory environments

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

Senior Scientist – Manufacturing Science

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 Description:**

The Senior Scientist – Manufacturing Science provides the technical support required to achieve the reliable and compliant manufacture of the API External Manufacturing (API EM) portfolio which includes raw materials, intermediates, enzymes and bulk drug substances. The Senior Scientist – Manufacturing Science executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity. In addition, the Senior Scientist – Manufacturing Science should be capable and technically independent in setting up and executing a variety of experiments at the laboratory scale and conduct research on manufactured product for process improvements and troubleshooting in the TS/MS laboratory.

**Key Objectives/Deliverables:**

- Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
- Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
- Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.
- Develop and monitor established metrics in real-time to assess process variability and capability.
- Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
- Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
- Provide support internal and joint process teams and to the global and local PLOT teams.
- Ability to independently set up and execute various chemical reactions.
- Ensure that experiments are well designed with clear objectives
- Ability to analyze data and ensure appropriate documentation
- Utilize save laboratory practice and adhere to CHP requirements
- Write technical reports and documents

**Basic Requirements:**

- Bachelors degree in scientific disciplines of Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, Analytical Chemistry.
- 3+ years of relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development.
- *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:**

- Demonstrated basic knowledge in small molecule API Manufacturing.
- Familiarity with cGMP manufacturing environment and terminology.
- Excellent analytical, interpersonal, written and oral communication skills.
- Ability to work independently as well as part of a team.
- Ability to prioritize activities.
- Good judgment and flexibility.

**Other Information:**

- Complete learning plan for API EM TS/MS Scientist.
- No certifications required.
- Tasks require entering manufacturing areas which require wearing appropriate PPE.
- Domestic and international Travel (variable, can approach 20%)

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

Advisor Engineer, Drug Product and Spray Drying Process Development - SMDD

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.

**Position Brand Description:**

The Synthetic Molecule Design and Development (SMDD) department within Lilly Research Labs is involved in key activities for the advancement of small molecules, peptides, and oligonucleotides from early discovery phases to commercialization. Our scientists and engineers develop innovative technical and business solutions across a portfolio of projects using their deep technical expertise to accelerate testing of clinical hypothesis and overall drug development. Through recognizing the value of a hardworking, diverse, and inclusive workforce, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients. Our team is seeking a highly motivated candidate to work on drug product process development, with a focus on amorphous solid dispersion manufacturing technologies such as spray drying and related particle engineering platforms, spanning Phase 2/3 clinical trials through registration and commercialization.

**Responsibilities:**

Candidates must possess a strong background in chemical engineering fundamentals, including heat and mass transfer, particle formation, and process scale-up, and be able to integrate this understanding with analytical and manufacturing considerations to advance drug product manufacturing processes. Specific responsibilities for this role include:

- Apply engineering fundamentals to design, scale up, and optimize amorphous solid dispersion (ASD) manufacturing processes, such as spray drying, hot melt extrusion, and/or coprecipitation, for producing drug product intermediates from lab and pilot scale through commercial manufacturing scale.
- Drive process development activities for drug product intermediates advancing toward commercialization, translating process and analytical understanding into a robust, scalable control strategy that supports commercial manufacturing readiness and regulatory filing.
- Support technology transfer and scale-up of manufacturing processes to internal and external sites.
- Collaborate and communicate project specific challenges and opportunities with key partners, including external contract manufacturing organizations, to plan and manage short- and long-term development activities aligned with the global CMC strategy.
- Engage and influence internal and external scientific communities to solve technical challenges, identify and implement novel drug product manufacturing technologies, and inform process and control strategy decisions.
- Author and review high-quality technical reports, peer reviewed publications, and regulatory documentation to support new technologies and regulatory submissions.

**Basic Requirements:**

- Ph.D. in Chemical Engineering, Pharmaceutical Sciences, or closely related STEM degree with 0-5 years of demonstrated experience in pharmaceutical process development, or
- M.S. in Chemical Engineering, Chemical Engineering, Pharmaceutical Sciences, or closely related STEM degree with 7+ years of demonstrated experience in pharmaceutical process development, or
- B.S. in Chemical Engineering, Chemical Engineering, Pharmaceutical Sciences, or closely related STEM degree with 10+ years of demonstrated experience in pharmaceutical process development.

**Additional Skills/Preferences:**

- Experience with process development and scale-up of particle engineering and/or amorphous solids manufacturing technologies (e.g., spray drying process, hot melt extrusion, co-precipitation, etc.).
- Experience in technical considerations for equipment design and integration, process monitoring, integration of process analytical technology (PAT) systems, and scientific approaches to control strategy. Involvement with process modelling and simulation programs for improved process and formulation understanding.
- Experience with technology transfer to external manufacturing partners and cross-site process comparability.
- Experience supervising or guiding the work of other engineers or scientists.
- Excellent oral communication and documentation skills.
- Demonstrate ability to effectively collaborate with multidisciplinary teams.
- Demonstrate leadership behaviors with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainty

**Additional Information:**

- Possible exposure to chemicals, allergens, and loud noises.
- Travel: 0 to 10%
- Position Local: Onsite Monday through Friday, 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

$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

Process Control & Automation Engineer (BMS/HVAC)

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 is currently constructing an advanced manufacturing facility for production of Active Pharmaceutical Ingredient (API) molecules located in Lebanon, Indiana, USA. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations.

The **Process Control and Automation Engineer (PCAE-BMS/HVAC)**  is the professional, responsible for the development, implementation, improvement, verification, and qualification of Building Management and HVAC Control Automation solutions for the Lebanon API Manufacturing site (LP1). These responsibilities include all activities necessary to support the automation solutions deployed to production, as well as area-engineering initiatives including commissioning, qualification, process improvements, solution enhancements and troubleshooting.

**Responsibilities:**

The **Process Control and Automation Engineer (PCAE-BMS/HVAC)** will be responsible for the management and implementation of applications (HW/SW) upgrades and updates. These upgrades/updates include creation and modifications of control strategies and data collections models as well as supporting the validation and qualification or verifications of those deliverables.

- PCAE-BMS/HVAC will be responsible for keeping up to date the documentation package for the applications.
- Working safely following all HSE standards.
- Perform activities in accordance with GMPs and applicable procedures.
- Stay tightly aligned and actively involved with the process team, as a participating member.
- Understand process team issues, priorities, and objectives.
- Respond to and implement process team decisions.
- Develop system requirements and designs.
- Manage and develop code in a GMP compliant manner.
- Deliver projects on time.
- Execute changes and resolve issues that ensure to keep systems up-to-date, reliable and complaint.
- Appropriately prioritize activities to maximize the overall impact on the business
- Understand and follow GMP concepts and compliance to influence development of procedures
- Provide input for continuous improvement effort (improve equipment reliability, etc.)
- Other tasks assigned by the supervisor.

**Basic Requirements:**

- Bachelor's degree in engineering or computer sciences, or related fields.
- 5+ years of automation engineering experience.
- 3+ years of experience as a BMS/HVAC Controls automation engineer (JCI, Honeywell, Siemens, Andover).
- 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:**

- Computer System Validation Experience.
- Computers Systems & Software Platforms administrations.
- Adequate interpersonal and communication skills to be able to work effectively in a team-based environment.
- Willing to learn about other areas outside of automation.
- Require the development of expertise in production processes, equipment specific code and control system technologies (Software/Hardware and field instrumentation).
- Certifications: Automation and Information Technology Certifications will be considered as a Plus (PAE, PCAE, CAN, CNE, VMP, etc).
- Licenses: Professional Engineering License will be considered as a Plus.
- Rockwell Software/Hardware Suite: Control Studio 5000, Logix, Factory Talk SE/ME/Asset Center, Historian Aveva Pi Software Suites: Pi Historian, PI Vision, Event Frameworks Logmate Working experience in IT platform support including: Server administration and Health Monitoring LAN/Network support and Troubleshooting Virtual HW Setup and administration.

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

Labeling and Packaging Scientist - Advanced Therapies Manufacturing

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 opened a cutting edge manufacturing facility dedicated to genetic medicines at Lebanon, Indiana. This facility is Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It includes next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.

**Position Description:**

Labeling and Packaging Scientist – Technical Services/Manufacturing Scientist (TS/MS) role will initially support the delivery of the gene therapy drug product labeling and packaging operations, specifically regarding technical transfer and process validation internally and externally. Upon the start of commercial production, this role’s objectives include maintaining the validated state of applicable processes, establishing and monitoring metrics/methods to ensure a state of capability and control, harmonization of control strategies across process teams, evaluate process improvement, and serving as an escalation point for day-to-day operations issues. The principal role is a position that develops and implements a technical agenda and is responsible for providing technical leadership for the labeling and packaging processes at the LP2 site.

**Key Objectives/Deliverables:**

- Understand the scientific principles required for labeling and packaging of drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
- Provide technical oversight for labeling and packaging materials.
- Provide labeling and packaging technical support to operations with respect to materials, equipment, and processes.
- Lead technical evaluations and specific problem resolution, including troubleshooting and root cause analysis.
- Lead risk assessments of labeling and packaging operations and material suppliers.
- Provide technical support for all start-up activities (e.g., tech transfer, process validation).
- Provide technical support for non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability.
- Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, etc.
- Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps.
- Support and/or own the technical agenda for the product or validation process.
- Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
- Serve as technical interface external to the LP2 site.
- Provide audit support, as needed.
- Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
- Collaborate with and influence partners across global packaging sites and teams along a specific product supply chain.
- Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.

**Basic Requirements:**

- B.S. engineering, packaging science, or related field
- 3+ years experience in a manufacturing organization focusing on labeling and packaging
- 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:**

- Pharmaceutical labeling and packaging manufacturing experience
- Root cause investigation experience
- Proven ability to work independently or as part of a team to resolve an issue.
- Strong attention to detail.
- Proficiency with computer systems including Microsoft Office products, Veeva Vault, electronic batch records, and SAP.
- Knowledge and understanding of manufacturing processes
- Strong interpersonal and teamwork skills
- Strong self-management and organizational skills

**Additional Information:**

- Off-hours support may be needed, by request.
- Required to respond, off shift, to operational issues.
- Minimal travel required.

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

$67,500 - $173,800

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, Process Engineer - Parenteral Drug Product Development

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.

**Position Summary:**

The Lilly Bioproduct Research and Development (BR&D) organization focuses on the development and commercialization of parenteral drug products of various modalities spanning from small molecules, peptides, oligopeptides, bioconjugates, proteins, vaccines to monoclonal antibodies, etc. The organization is also committed to the development of genetic medicines which includes active investments in AAV, LVV, mRNA, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in building new technology capability to support complex drug product commercialization in different drug product presentations such as co-formulation, high concentration, and long-acting presentations, etc. in different devices as the combination products.

We are seeking a highly motivated process engineer leader with extensive industry experience and knowledge in parenteral drug product process development from compounding to fill/finish to advance Lilly portfolio from clinical to commercialization. This position is located at Lilly’s tech center, next to Lilly’s headquarter in Indianapolis. This position seeks a candidate with extensive industry experience in process development. This candidate would drive cross-functional collaboration with Lilly internal and external key stakeholders to advance portfolio assets. If you are interested in developing novel medicine to serve millions and millions of patients, you should consider joining our diverse and high-performing team.

**Responsibilities:**

- Lead talented scientists to design and execute complex process studies to define clinical and commercial manufacturing process for various parenteral drug products. Mentor scientists to improve their scientific understanding in study design capabilities.
- Lead the efforts to design the process development and characterization of various new modalities, especially novel drug product presentations for late-stage process development, including assessing and mitigating process risks during scale-up via a deep understanding of in-process and final product critical quality attributes and critical process parameters.
- Drive collaboration with Lilly’s internal and external key stakeholders to address complex tech transfer challenges across sites, including both internal and external manufacturing organizations, and work closely with stakeholders to ensure the integration of novel excipients and technologies into CMC development timeline and appropriate pathway for regulatory submission.
- Drive collaboration with clinical manufacturing team to support clinical manufacturing at internal and/or external CMOs. Author and review tech transfer related documents and review batch records to ensure accuracy of the manufacturing steps and process parameters. Provide onsite technical oversight of clinical manufacturing to address any technical hurdles during manufacturing.
- Ensure consistency in technical deliverables and documentation across transfers.
- Cross-Functional Collaboration: Represent BRD organization on project teams. Partner with cross-functional stakeholders including but not limited to project management, analytical development, quality, device delivery, supply chain, internal/external manufacturing, tech/manufacturing service to define drug product and CMC timeline along with key deliverables to meet the requirements for regulatory submission.
- External Engagement: Establish and leverage strategic relationships with academic and industry partners to adopt new process technologies to accelerate product development.
- Innovation: Initiate and drive innovation to tackle complex new modalities process performance and product quality for various new modalities as well as new technologies. Actively involve and contribute to BRD and cross-functional innovation to support PRD strategy decision. Present scientific findings and present to internal and external stakeholders and leverage the innovations to advance Lilly portfolio.

**Basic Requirements:**

- Ph.D. in Chemical Engineering, Biomedical Engineering, or Pharmaceutical Sciences are highly preferred with a minimum of 7 years of industry experience directly in parenteral drug product process development from bulk drug product compounding to fill/finish.
- Extensive experience and knowledge with process development of parenteral drug products such as peptides, ADCs, fusion proteins, mAbs and vaccines manufacturing process is required.
- Large scale process development experience from clinical to commercialization is required.
- Hands-on experience in designing and optimizing manufacturing processes including large scale compounding, filtration and fill/finish is required.
- Strong knowledge and experience with regulatory submissions (INDs, NDAs and/or BLAs of parenteral drug products is required.
- Strong understanding of cGMP requirements, ICH and regulatory guidelines is a must.

**Additional Information:**

**Physical Demands/Travel:**

The physical demands of this job are consistent with a lab environment.

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

**Work Environment:**

This position’s work environment is in a laboratory environment.

*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

$151,500 - $239,800

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

Process Safety Lead

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.

The Engineering Technology Center (ETC) is a group of skilled engineering practitioners who possess deep technical expertise. The primary role of this position is to provide process safety related technical support to manufacturing. The ETC partners with manufacturing and other engineers across the company to deliver capital projects, address operational issues, and provides solutions to key business problems across the company.

**Responsibilities:**

This role is the Process Safety Management technical resource in the ETC.

- Become a key engineering/technical resource for the GIPSM processes across Lilly such as Mechanical Integrity, Process hazards, Pressure safety, and others.
- Be a corporate technical resource on pressure relief hazards.
  - Provide internal capability to calculate or evaluate pressure relief system sizing.
  - Recommend external resources for evaluation and sizing of emergency pressure relief systems.
  - Review third party evaluations of pressure relief system design.
- Be a corporate technical resource on Mechanical Integrity
  - Provide technical expertise to ensure alignment with recognized engineering practices and Lilly global engineering standards
  - Understand critical safety system components and design to support LOPA evaluations
  - Provide inspection expertise with respect to technology and program setup
  - Support standardization of MI elements within maintenance package development
  - Support standardization of Asset Integrity & Repair with respect to Operational Readiness Reviews
- Become engineering resource on key GPSIM processes such as Process hazards reviews, process hazard evaluations, LOPA, event investigation, etc.
- Partner with GHSE on technical solutions for safety related trends and ownership of key GHSE standards and expectations
- Partner with LRL colleagues on ensuring process safety related aspects are considered when developing new processes, products.

**Adaptability**

- Flexibility in adapting and adjusting to changes in working practices and willingness to take on different roles as required by the needs of the Engineering Tech Center
- Ability to work with diverse perspectives and to identify and resolve issues with minimal direction.

**Basic Qualifications:**

- Bachelor's in Engineering (e.g. Chemical Engineering)
- Minimum 8 years' experience in pharmaceutical and/or specialty chemical laboratory and/or manufacturing environments
- *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:**

- Professional engineering license.
- Experience as a mechanical or process engineering in two or more of the following areas: small molecule bulk, large molecule bulk, dry products, parenteral products, delivery devices, utilities, facilities management, Lilly Research.
- Demonstrated knowledge of US and non-US codes and standards applicable to emergency pressure relief.
- Must have demonstrated good written and verbal communications skills. Demonstrated ability to work within and lead diverse, multi-functional teams (i.e. Engineering, Manufacturing Operations leadership, TS/MS, etc.).
- Demonstrated project management, interpersonal and communication skills.
- Ability to identify and resolve issues with minimal direction.
- Demonstrated familiarity with understanding and application of common engineering specifications/standards to identify and resolve issues with minimal direction.
- Must be able to work in an environment where limited or conflicting direction is given.
- Qualified to perform emergency relief calculations.
- Knowledgeable of first principles.

**Additional Information:**

- ETC supports all business areas across the globe. Business travel both inside and outside the U.S. may be required.

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

$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

Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform

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.

This role provides strategic, tactical, and operational regulatory CMC leadership across advanced therapeutic modalities and manufacturing technologies to accelerate development of the synthetic peptides and oligonucleotide portfolio, supporting clinical trial applications, market registrations, and post-approval submissions. This is accomplished through a strong working knowledge of global regulations, guidelines, and regulatory precedent, coupled with deep technical expertise in CMC development and manufacturing processes specific to synthetic peptides and oligonucleotides.

**Key Responsibilities**

- Deep technical knowledge of synthetic peptide and oligonucleotide CMC drug development and manufacturing sciences across modalities and platforms, including drug substance, drug product, and analytical sciences (e.g., solid-phase synthesis, purification, conjugation, characterization, and control strategies).
- Knowledge of global CMC regulatory requirements and guidelines for synthetic peptides and oligonucleotides to support clinical development, global product registrations, and lifecycle management of approved products.
- Development and implementation of innovative regulatory strategies and platform-based approaches, incorporating evolving external expectations (e.g., emerging guidance, novel modality considerations, and regulatory precedent).
- Provide regulatory guidance enabling CMC development teams to make well-informed decisions on development strategies and lifecycle planning.
- Lead preparation, critical review, and approval of CMC documentation for global regulatory submissions and responses, including clinical trial applications, marketing applications, variations/supplements, and responses to health authority queries.
- Take a proactive leadership role in the critical review of molecule-specific CMC development and lifecycle strategies, including considerations unique to peptides and oligonucleotides (e.g., impurity profiles, sequence-related variants, delivery systems, and stability).
- Provide high-quality, timely, and clear regulatory advice to support project teams in advancing complex modalities.
- Make decisions on CMC regulatory strategies impacting global submissions, ensuring alignment across geographies, teams, and platform approaches.

**Basic Qualifications/Requirements**

- B.S. degree in a science, engineering, or related STEM field (advanced degree preferred), such as Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biochemistry, Molecular Biology, or similar.
- 10+ years of Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic peptides, oligonucleotides, or related complex modalities. Candidates with broader experience in advanced modalities are encouraged to apply.

**Additional Skills/Preferences**

- Experience authoring CMC submission content for peptides and/or oligonucleotides, including participation in clinical trial and marketing authorization applications and responses to regulatory questions.
- Knowledge of major global regulatory procedures, regulations, and evolving expectations for complex modalities, including platform technologies.
- Relevant experience in peptide and/or oligonucleotide drug substance and/or drug product development, manufacturing, and commercialization.
- Demonstrated understanding of key development considerations for peptides and oligonucleotides (e.g., synthesis scalability, impurity control, analytical characterization, stability, and delivery systems such as conjugates or lipid-based formulations).
- Extensive regulatory experience managing complex submission strategies or equivalent combination of technical and regulatory expertise.
- Experience planning for and participating in Health Authority interactions.
- Demonstrated ability to assess and manage risk in a highly regulated and evolving modality space.
- Strong written, verbal, and presentation communication skills.
- Demonstrated leadership, with strong influencing and negotiation skills.
- High attention to detail and commitment to quality.
- Strong collaboration skills with ability to work effectively across diverse, cross-functional teams.

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.

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