Quality

Eli Lilly and Company

Principal - QA API External Manufacturing Peptides

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.

Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world.

Job Summary:

This role provides essential Quality Assurance oversight for API External Manufacturing operations, ensuring compliance with cGMP and regulatory requirements for all products manufactured by third-party partners.

**Job Responsibilities:**

- Lead and manage quality aspects of external API manufacturing sites, including but not limited to batch record review, disposition, deviation management, and change control.
- Conduct and/or participate in quality audits of external manufacturing sites to assess compliance with cGMP, regulatory expectations, and Eli Lilly's quality standards.
- Review and approve quality-related documents, such as manufacturing master batch records, validation protocols and reports, stability data, and analytical methods.
- Collaborate cross-functionally with internal teams (e.g., Supply Chain, Regulatory Affairs, Technical Services) and external manufacturing partners to resolve quality issues and drive continuous improvement.
- Provide expert QA guidance and support during new product introductions and technology transfers to external manufacturers.
- Develop, implement, and maintain quality agreements with external manufacturing organizations.
- Investigate and troubleshoot complex quality incidents, deviations, and out-of-specification results, determining root causes and implementing effective corrective and preventive actions (CAPAs).
- Represent Eli Lilly's quality interests during regulatory inspections at external manufacturing sites.
- Mentor and provide technical guidance to junior QA associates.

**Basic Requirements:**

- Bachelor's degree in Chemistry, Biochemistry, Pharmacy, Chemical Engineering or related scientific discipline.
- Minimum 5 years experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry, with a strong focus on API manufacturing and external supply.
- Experience in cGMP regulations (FDA, EMA, HPRA, etc.) and global pharmacopeial requirements.
- Experience in auditing external manufacturing sites.
- Experience in quality management systems (e.g., Veeva).
- Willingness to travel domestically and internationally to external manufacturing sites as 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 Preferences:**

- Strong understanding of API manufacturing processes, analytical techniques, and quality control principles.
- Demonstrated ability to make sound quality decisions and effectively communicate complex technical and quality information to diverse audiences.
- Excellent problem-solving, analytical, and critical thinking skills.
- Ability to work independently and as part of a team in a fast-paced, dynamic environment.

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

$65,250 - $169,400

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

Advisor, Physicochemical Properties and Compound Quality

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 Overview:**

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

Advanced Molecule Design (AMD) is dedicated to optimizing molecules into strong drug candidates that become breakthrough medicines for patients. AMD brings together core functional areas — medicinal chemistry, synthetic chemistry, analytical chemistry, computational chemistry, and molecular pharmacology — to accelerate the identification and advancement of high-quality small molecule candidates across a breadth of modalities and therapeutic areas.

Discovery Chemistry Technologies (DCT), a key function within AMD, provides critical scientific expertise and technology solutions that support molecule optimization and scale-up efforts. Within DCT, the Discovery Analytical Chemistry team integrates deep expertise in analytical characterization, separation science, method development, and molecular property assessment to drive compound progression and inform critical portfolio decisions. The team generates high-quality data — spanning structural confirmation, purity determination, stability evaluation, and physicochemical profiling — that enables discovery teams to make rapid, confident decisions across the design-make-test-analyze cycle. Team members are expected to embrace collaboration, adopt a forward-thinking and growth-oriented mindset, and take individual responsibility for their scientific contributions and professional development.

Join our Lilly Small Molecule Discovery team to drive the characterization and optimization of novel drug candidates that could become tomorrow's breakthrough therapies. We're seeking a highly motivated Analytical Chemist with deep expertise in physicochemical property analysis, Liquid Chromatography-Mass Spectrometry (LC-MS), and Supercritical Fluid Chromatography-Mass Spectrometry (SFC-MS) to serve as an embedded analytical expert within our discovery programs.

In this role, you will work directly with medicinal chemists to provide critical analytical insights that guide synthetic strategy and compound progression decisions. Your expertise in ADME/DMPK property profiling, solubility assessment, stability analysis, and structural characterization using LC-MS, SFC-MS, LC-MS/MS, and high-resolution mass spectrometry will be essential to identifying and advancing the most promising lead candidates.

The compounds you characterize and optimize today may become the breakthrough therapies patients need tomorrow. Your analytical insights will directly influence which molecules advance from discovery into clinical development.

You will also lead the integration of purity and stability analyses with our global sample management organization to maintain our world class compound collection

**Key Responsibilities:**

- **Physicochemical Property Characterization:**
  Design and execute experiments to measure key physicochemical properties (e.g., solubility, pKa, logD/P, stability, Polar Surface Area) of new chemical entities (NCEs) and drug candidates in the early stages of discovery. These are either measured directly or via surrogate chromatographic methodology, such as SFC-MS or LC-MS. Holistic assessment of these properties in conjunction with other characterization data will guide decisions on SAR, bioavailability, future formulation, and drug delivery.
- **LC-MS Method Development & Application Assessing Critical Quality Attributes:**
  Develop and optimize LC-MS methods for purity, identity, and stability analysis for a variety of pharmaceutical compounds, impurities, and potential drug candidates. Ensure method sensitivity, reproducibility, robustness, and speed of analytical methods to support the discovery timelines.
- **Data Analysis & Reporting:**
  Process and interpret complex chromatographic and spectrometric data to generate contextualized and actionable results. Present results and conclusions to cross-functional project teams and key stakeholders to enable rapid and reliable decision making.
- **Documentation & Compliance:**
  Maintain accurate and detailed laboratory notebooks and reports in accordance with internal company standards. Ensure proper documentation of experimental protocols, results, and any deviations or issues.
- **Innovation & Continuous Learning:**
  Stay current with advancements in analytical chemistry, LC-MS techniques, and drug discovery trends. Continuously identify opportunities to enhance laboratory efficiency, improve analytical techniques, and contribute to the scientific knowledge base. Demonstrate scientific rigor to develop new and novel experiments and techniques to enable and speed up the discovery pipeline.
- **Cross-Functional:**

Effectively partner with chemists, pharmaceutical formulation scientists, ADME/DMPK scientists, computational scientists, and data scientists.

**Qualifications:**

- **Minimum:**
  - PhD in Analytical Chemistry, Pharmaceutical Sciences, or a closely related discipline with 5+ or Masters with 10+ years of post-education hands-on experience with LC-MS, SFC-MS, LC-MS/MS, and physicochemical techniques in a small molecule pharmaceutical discovery environment.
- **Preferred**
  - In-depth proven track record determining physicochemical properties and driving cross-functional impact on drug design and development.
  - Experience working closely with ADME/DMPK and providing contextualized results taken from analytical data in early drug discovery.
  - Well versed in analytical data/results management.
  - Extensive hand-on experience with nominal mass and high resolution LC-MS and SFC-MS instrumentation, including method development, optimization, and troubleshooting (Agilent, Waters, Shimadzu.)
  - Expert in the broad range physicochemical properties and their relationship to critical success factors for medicinal chemistry projects
  - Deep understanding of chromatography and mass spectrometry theory and proven track record for creatively applying these to the laboratory environment
  - Well versed in ADME/DMPK testing strategies and the role of physicochemical properties in early-stage drug discovery.
  - Proficiency with data analysis software such as MassLynx, ChemStation, Mestrelabs or similar.
  - Demonstrated ability to apply data/information/results workflow enablers such as KNIME and state of the art AI tools.
  - Strong analytical and problem-solving abilities.
  - Excellent communication skills to effectively present data to both scientific and non-scientific stakeholders.
  - Ability to work independently while collaborating effectively with multidisciplinary teams.
  - High attention to detail and organizational skills to manage multiple projects simultaneously.
  - High learning ability and adaptability.
  - Ability to challenge status quo and to influence across organizations.

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

$126,000 - $204,600

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

\#WeAreLilly

Principal/Sr. Associate-QA-API External 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.

The API EM Quality Assurance Consultant provides support to all quality activities at Contract Manufacturing organizations (CMs). The QA Consultant’s position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments.

**Key Objectives/Deliverables:**

- Serve as a liaison between CMs and Lilly.
- Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
- Escalate quality issues at CMs to Lilly QA management.
- Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
- Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
- Provide quality oversight of Lilly/APIEM Quality Plans
- Coordinate and perform QA responsibilities of API shipments from suppliers and CMs.
- Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections.
- Participate on the Technical Review Board
- Evaluate and disposition API batches, if required.
- Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
- Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
- Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
- Ensure all processes are in an appropriate state of control.
- Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
- Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations.
- Participate in APR activities.
- Participate in projects to improve productivity.
- Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.

**Basic Requirements:**

- Bachelors degree in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
- At least 2 years previous GMP manufacturing experience in API or Pharma experience in finished product manufacturing, QA, Technical Services or Engineering.
- *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 quality support for Quality Control activities
- Thorough technical understanding of quality systems and regulatory requirements.
- Knowledge of pharmaceutical manufacturing operations.
- Demonstrated coaching and mentoring skills.
- Experience in root cause analysis.
- Demonstrated application of statistical skills.
- Demonstrated strong written and verbal communications skills.
- Strong attention to detail.
- Proficiency with computer system applications.
- Excellent interpersonal skills and networking skills.
- Ability to organize and prioritize multiple tasks.
- Ability to influence diverse groups and manage relationships.

**Other Information:**

- Must complete required training for API EM Quality Assurance.
- No certifications required.
- Must be able to support 24-hour/day operations.
- Continental and Intercontinental travel may occur (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

Process Instrument Technician - Maintenance - IAPI

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 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.

This position provides Process Instrumentation maintenance support within Indy Pharmaceutical Manufacturing.

This position will focus on equipment uptime, calibration and reliability. The applicant will work closely with Production, Engineering, Quality Control, Labs and various other groups to troubleshoot, maintain and perform Corrective and Preventative maintenance on Process Instrumentation and provide project support on production and utility related equipment.

**Key Objectives/Deliverables:**

- Demonstrate a good process aptitude and application of skills in a variety of real-world process experiences. (e.g., transmitters ranging from pressure, temperature, flow, PH, and level.)
- Install/set-up/replace Instrument/electrical equipment (e.g., switches, transmitters, controllers, VFDs, various types of process instrumentation).
- Diagnose basic electrical problems, to effect repairs and restore equipment/systems to operating condition (e.g., 3-wire motor control, 12/24V control circuits, 120V circuitry, etc).
- Effectively troubleshoot electrical equipment from 24 VDC to 480 VAC to restore equipment/systems to operating condition.
- Operate basic electrical/pneumatic test equipment and meters (e.g., fluke, signal generators, oscilloscopes, Amtek, MKS).
- Provide Process instrumentation support for equipment qualification.
- Provide accurate, complete, and legible Work Order documentation on both paper copy (when required) and in CMMS work order system (Maximo, SAP, etc).

**Basic Qualification:**

- High school diploma/GED
- Associate degree or Technical Trade Certificate in Electrical/Automation/Instrumentation, or equivalent experience
- Minimum 3 Years of Maintenance instrumentation experience
- Completion of Post Offer Exam or Work Simulation, as applicable
- 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:**

- Experience within a regulated industry; FDA regulated industries preferred
- Ability to perform quality work without close supervision
- Proficiency in CMMS (e.g., Maximo), Microsoft Word, and Microsoft Excel.
- Experience in providing a high-level of customer service
- Ability to follow written procedures while performing maintenance activities
- Ability to work in team environment.
- Track record of maintaining a neat and orderly work area (good housekeeping)
- Experience performing maintenance in a Manufacturing environment
- Demonstrated knowledge of troubleshooting process related equipment failures
- Good documentation practices and communication skills (both written and verbal)
- Demonstrated record of maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

**Additional Information:**

- Requires open shift availability (Days, Nights, Weekends) to meet business needs. This position will be 12 hour night 3 on/3 off.
- Must be willing to work overtime during peak periods (e.g. Maintenance Shutdowns, Changeovers, etc.). Schedule could change due to business needs for additional coverage during Shutdowns, training and peak vacation times.
- Individual must be able to comply with all building gowning and SOP requirements and be expected to perform in various areas within manufacturing

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

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

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

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

$21.63 - $42.31

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

\#WeAreLilly

Sr. Principal - QC Technical Resource (PAT & Automation)

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 API molecules located in Houston, TX. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

This role serves as a technical leader within the QC laboratory, driving advancement of analytical methods, systems, and overall testing capability while guiding complex scientific decisions. The position leads the site's Process Analytics Technology (PAT) and QC laboratory automation strategy, partnering closely with Manufacturing, Automation/Engineering, and Digital teams to integrate in-line, on-line, and at-line analyzers and automated lab systems into a greenfield facility build-out. It partners cross-functionally to solve challenging technical issues, influence broader quality and manufacturing strategies, and serves as a QC subject matter expert for site and global initiatives.

This position is a recognized expert who makes key technical decisions impacting multiple teams, leads the resolution of highly complex challenges, and influences technical strategy across functions. The role delivers innovations with cross-functional impact, leads significant initiatives, mentors outside their own discipline, and serves as an effective supporter of culture change.

**Responsibilities**:

- Provide technical leadership for the QC laboratory by guiding the development and improvement of testing methods, quality systems, and analytical capabilities while serving as a technical authority in complex decision-making forums.
- Serve as site lead for Process Analytics Technology (PAT), driving the selection, qualification, and lifecycle management of in-line, on-line, and at-line analyzers, and defining the site's PAT roadmap in alignment with the overall QC and manufacturing control strategy.
- Lead QC laboratory automation initiatives, including LIMS/LES integration, automated sample handling and robotics, and data historian connectivity, to improve throughput, right-first-time performance, and data integrity across the QC organization.
- Lead the resolution of complex technical challenges by applying advanced scientific knowledge across multiple disciplines and designing novel solutions that enhance accuracy and efficiency across QC operations.
- Collaborate and influence across Manufacturing, Quality Assurance, Technical Services, Regulatory, Product Development, Automation/Engineering, and Digital, as applicable, to integrate QC considerations into broader business decisions and serve as a subject matter expert during regulatory inspections and audits.
- Execute all Quality Control activities in a timely manner, in compliance with applicable SOPs, methods/protocols, good documentation practices, data integrity standards (ALCOA+), cGMPs, EHS requirements, chemical hygiene, and biosafety guidelines, maintaining an ongoing state of inspection readiness and providing support during audits and inspections as requested.
- Identify and escalate atypical results and potential deviations, participate in root cause investigations and corrective/preventive actions, contribute to cross-functional teams and continuous improvement initiatives, and maintain training competencies to ensure only qualified work is performed.

**Basic Qualifications:**

- Minimum Bachelor’s degree in a science or engineering discipline.
- 5+ years of laboratory experience in pharmaceutical or regulated GMP manufacturing industry.
- 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:**

- Extensive experience providing advanced technical oversight in a GMP-regulated QC laboratory, including comprehensive data review, troubleshooting methods, and scientific decision-making for complex analytical or microbiological issues.
- Experience with Process Analytical Technology (PAT) instrumentation and platforms (e.g., NIR, Raman, or other in-line/on-line/at-line analyzers), including selection, qualification, and integration with manufacturing control systems.
- Experience with QC laboratory automation and informatics systems (e.g., LIMS/LES, automated sample handling, robotics, or data historians), including implementation or lifecycle support.
- Proven track record of leading or significantly contributing to analytical method transfers, validations, and lifecycle management activities, with the ability to author technical protocols, reports, and regulatory submissions.
- Demonstrated ability to serve as a subject matter expert during regulatory inspections and audits, including the ability to clearly articulate scientific rationale, defend analytical strategies, and respond to complex technical questions.
- Experience influencing cross-functional decisions (Manufacturing, QA, Regulatory, Product Development) through technical credibility and data-driven recommendations, with a track record of driving QC-initiated improvements at the site or global level.
- Prior experience mentoring QC scientists and technicians on advanced analytical concepts, emerging technologies, and structured problem-solving approaches, contributing to overall team capability development.
- Proficient in good documentation practices (GDP) and data integrity principles (ALCOA+).
- Proven ability to communicate and collaborate effectively with 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

$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

Texas

Night Shift Technician - Utilities Maintenance

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

**Organization Overview**

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.

**Responsibilities**

The Utilities Maintenance Technician will join the Utilities, Facilities, and Project Engineering team to provide maintenance expertise at the Lilly Kenosha County (LKC) campus to service, repair, and maintain HVAC (GMP and Non-GMP) and Utilities systems, both GMP (PW, WFI, Clean Steam, Process Compressed Air, etc.) and non-GMP (Plant Steam, Chilled Water, Water, Waste Neutralization, Sewer, etc.) and the ancillary systems associated within their facilities.

The Utilities Maintenance Technician is expected to understand the needs and requirements of the customer (Operations) and must be able to work effectively with customers, handle customer questions with tact and understanding while displaying good customer service.

- This role is expected to improve equipment uptime, line efficiency, and increase overall equipment effectiveness in a production environment by condition monitoring, troubleshooting, and assisting in engineering changes.
- Must possess a good mechanical aptitude to troubleshoot and repair equipment while following departmental rules and regulations.
- Must be willing to work with safety as a primary focus and abide by applicable safety procedures and practices.
- Troubleshoot the root causes of machine problems (e.g., excessive vibration or temperature, bearing failures, abnormal noises, and poor performance).
- Perform repairs and overhaul equipment (e.g., gear boxes, pumps, blowers, fans, and drives) to include disassembly, setting tolerances, aligning, resetting timing (e.g., air compressors, vacuum pumps).
- Setup equipment to design specifications (e.g., timing, leveling, alignment).
- Operate precision alignment equipment (e.g., Rotalign, lasers, etc.)
- Must have the ability to diagnose the root cause of a problem and implement the proper corrective actions to minimize downtime quickly and accurately.
- Must accurately document the actions taken to repair the equipment in the CMMS program.
- Willing to assist in areas outside of their primary responsibility and learn other skills, as required.

**Basic Requirements**

- High School Diploma / GED.
- Minimum 2 years of Automation experience.
- *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**

- Must be able to speak, read, and write English at a sufficient level to communicate technical and business information effectively.
- Must be able to effectively use business software programs, such as Maximo, Microsoft Outlook, Microsoft Office Suite, and other required software programs.
- Must be able to effectively work in a team environment.
- Physical considerations include the ability to work with or around equipment, climb ladders and stairs and use PPE (Personal Protective Equipment). May be exposed to harsh weather conditions as part of the job.
- Good, all-around hands-on experience with repair of equipment.
- Use basic troubleshooting equipment such as multi-meters, calipers, etc.

**Additional Information**

- The Utilities Maintenance Technician will work in and around potentially dangerous and hazardous equipment, powders, liquids, and gases. Safety is paramount for this position.
- This position will be a night shift schedule, with a 3, 2, 2 schedule.

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

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

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

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

$21.27 - $41.25

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

\#WeAreLilly

Wisconsin

Sr. Director - Quality Control Laboratories

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 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 Huntsvilles Alabama. 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 Lilly Site 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.

The Sr. Director – QC Laboratories will provide administrative leadership for the quality laboratories and ensure appropriate capabilities and business processes are developed at the site. The role will define and lead the organization that will support the quality control and analytical laboratories in support of the site and Lilly’s growing pipeline. Within quality control, a state-of-the-art facility will utilize the latest in automation to further the analytical capabilities. These capabilities include everything from on-line in process testing through stability and ongoing process monitoring. The analytical capabilities team will consist of high-level scientist focused on the implementation/transfer of new modalities, proposal, and implementation analytical process improvements, along with the establishment of a center of excellence for molecule characterization. This position involves working cross functionally within the site and across the network to develop the strategic functional capabilities needed to support the mission of the site.

The individual in this role must have expertise in analytical operations and quality systems and a demonstrated ability to develop and lead large teams, lead leaders within an organization, and influence across the networks and with global organizations.

**Responsibilities:**

**Business Support**

- Build a high-quality organization in support of Quality Laboratory Operations
- Maintain GMP Compliance in all Laboratory Operations
- Deliver the lab of the future vision for LP1 including integrated digital, paperless processes.
- Participate on the local area lead teams and Quality Lead Team.
- Works closely with Global Quality Laboratories and Global QC Operations to ensure consistent and standardized approaches to laboratory organizational design, business processes, and systems.
- Exhibit critical business decision bringing about successful results.
- Communicate to and strive for integration with support groups inside and outside the plant.
- Coordinate laboratory related business planning and budget management.
- Ensure safe work environment that complies with regulations.
- Serve as a conduit for corporate communications as needed.

**Compliance Oversight**

- Quality and compliance consistency across laboratories.
- Coordinate and manage all regulatory and internal inspections.

**Personnel Development**

- Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports.
- Recruit new talent and develop site capabilities to deliver a high functioning QCL organization.
- Ensure administrative and technical capability within the organization.

**Basic Requirements:**

- Bachelor’s degree in chemistry, microbiology, engineering, or related discipline
- Minimum of 10 years supporting complex analytical testing (chromatography, bioassay, and analytical characterization)
- 2+ years working in a GMP/cGMP environment
- 5+ years leadership experience
- Expertise in quality and compliance requirements for analytical laboratories
- Experience with regulatory submissions

**Additional Skills/Preferences:**

- Proficiency with computer systems including Microsoft Office products
- Demonstrated technical writing ability
- Demonstrated strong oral and written communication
- Demonstrated interpersonal skills with ability to lead leaders and influence cross-functionally and externally
- Demonstrated ability to maintain a safe work environment

**Additional Information:**

- Ability to travel (approximately 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

$156,000 - $228,800

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

Alabama

Sr. Director - API Manufacturing Quality Assurance

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 API molecules. This facility 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.

**Position Overview**

The Sr. Director – QA serves as the Site Quality Leader for the Lilly API site, overseeing manufacturing, utilities, laboratories, and warehousing. This role ensures the strength and continuous improvement of all quality and compliance systems, activities, and personnel. Additionally, the Sr. Director – QA is responsible for maintaining utilities and ensuring that raw materials and drug substances are produced and released in accordance with cGMP standards and marketing authorization requirements.

**Key Responsibilities**

- Serve as Site Quality Leader on the Lilly Site Lead Team.
- Ensure site-wide compliance with cGMPs, procedures, standards, and regulatory commitments.
- Lead the API Quality Team and manage its agenda.
- Support quality forums (e.g., Deviation and Change Control Boards).
- Develop and monitor a site Quality Plan and metrics.
- Coordinate and manage regulatory inspections.
- Review and approve manufacturing and quality system documents.
- Ensure adequate QA staffing and provide coaching and development.
- Use HR tools for performance management, staffing, and succession planning.
- Contribute to QA business planning and site-wide strategic planning.

**Basic Requirements**

- Bachelor's degree (STEM degree preferred)
- 10+ years of pharmaceutical manufacturing quality experience
- 5+ years of supervision/leadership experience

**Additional Preferences**

- Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs
- Proficient in statistical analysis and computer applications
- Strong interpersonal, communication, and networking skills
- Ability to influence diverse teams and manage multiple priorities
- Demonstrated problem-solving and analytical thinking

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

$156,000 - $228,800

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

Sr Director - Engineering (Automation, Maintenance, Process)

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

**Position Overview**

The Senior Director is responsible for leading the site’s process-facing engineering functions—including process engineering, automation, and maintenance—to ensure the team has the capacity, capability, and leadership to support site startup and long-term manufacturing goals. This role provides both administrative and technical leadership for engineering operations.

As a member of the Lilly Site Lead Team, the Senior Director contributes to shaping the site’s strategic direction, building organizational capability, and managing cross-functional issues. The team works collectively to achieve long-term business objectives, adapt to evolving corporate and external environments, and develop the site for future success.

During the project delivery and startup phases, the Site Lead Team will operate dynamically to support project execution, build the organization, implement GMP systems and processes, and establish site culture. This will require strong collaboration, creativity, and resilience.

**Responsibilities**

**Pre-Startup & Startup Phase**

- **Organizational Development**: Collaborate with the Site Lead Team to build a capable, inclusive, and resilient organization focused on safety, quality, and operational excellence.
- **Functional Strategy**: Define priorities and roadmap for process engineering, automation, and maintenance. Develop systems and processes by leveraging internal expertise and external best practices.
- **Safety Leadership**: Actively contribute to the site HSE Lead Team to ensure safety is embedded throughout project delivery and startup.
- **Project Support**: Act as end user for process equipment—providing input on design, commissioning, and startup plans to align with both project and long-term site goals.
- **Team Structure**: Design and evolve the engineering organization to ensure the right resources and leadership are in place for GMP manufacturing.
- **System Readiness**: Ensure qualified and safe states for equipment, processes, utilities, and facilities are established and maintained.
- **Corporate Alignment**: Build strong technical relationships with corporate teams and champion strategic initiatives at the site level.

**Post-Startup Phase**

- **Ongoing Strategy Execution**: Continue refining and executing the engineering roadmap, aligning functional goals with site priorities.
- **Compliance & Standards**: Ensure adherence to corporate policies and standards across environmental, safety, and quality domains.
- **External Benchmarking**: Maintain an outward focus to identify and apply best practices from across the industry and internal network.
- **Asset Management**: Partner with Facilities Engineering to manage site investments—planning, prioritizing, and executing capital projects aligned with site objectives.
- **Operational Integrity**: Ensure equipment remains in a qualified and safe state, and that maintenance is performed and documented to the highest standards.
- **Governance & Controls**: Establish and maintain robust control systems to manage compliance and escalate issues appropriately.
- **Leadership Development**: Cultivate future technical and managerial leaders for the site and potential global roles.

**Basic Requirements**

- Bachelor's degree in an engineering discipline.
- 10+ years of experience in a leadership role managing teams within the pharmaceutical industry.

**Additional Preferences**

- Experience in API manufacturing, including implementation of a Process Safety Management program.
- Strong understanding of cGMPs and their application to manufacturing operations.
- Proven ability to build effective relationships across all organizational levels—from site leadership to frontline teams.
- Demonstrated success in leading projects from initiation to completion, meeting timelines, budgets, and performance standards.
- Track record of developing and managing high-performing, engaged teams with a focus on safety, quality, and strong team culture.

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

$163,500 - $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

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

High Voltage Electrician - Maintenance

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.

**Title: High Voltage Electrician – Maintenance**

Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) 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 startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

**Position Brand Description:**

The High Voltage Electrician - Maintenance has the responsibility of servicing, troubleshooting, and maintaining equipment in LTC utilities that includes high purity water, compressed air, steam, chilled water, glycol, city water, and sewers. The High Voltage Electrician - Maintenance is expected to display good customer service skills and to ensure that utility equipment and buildings are maintained at all utility locations. The High Voltage Electrician - Maintenance is expected to assist craftspeople in multiple crafts.

**Key Objectives/Deliverables:**

- Perform preventative and corrective maintenance on 480V, 4160Vand 13.8kV electrical systems (Circuit Breakers, 13.8KV Main Switch gears, Motor Starters, Fuses, ground fault interrupts).
- Perform preventive maintenance on complex Electrical Equipment (e.g., motor control centers, variable-speed drives, programmable logic controllers, etc.).
- Troubleshoot and diagnose Electrical Equipment problems and make appropriate repairs to minimize downtime.
- Perform modifications and new installations of Electrical Equipment.
- Diagnose complex electrical problems to effect repairs and to restore equipment/systems to operating condition.
- Install/replace complex electrical equipment (e.g., motor control centers, main switch gear, etc.).
- Demonstrate the ability to read P & ID drawings and schematics.
- Consistently comply with safety rules and closely following approved procedures to ensure cGMP compliance.
- Document all work by following Good Documentation Practices.
- Performance of work requires strict compliance with safety rules and closely following approved procedures for ensuring cGMP compliance.

**Basic Qualifications:**

- High school diploma or equivalent.
- Experience maintaining 480V, 4160V and 13.8kV electrical systems (medium-voltage switchgear, circuit breakers, motor starters and fuses).
- Mechanical aptitude and strong troubleshooting skills.
- Experience using a CMMS (e.g., GMARS) or similar work order tracking systems and documenting work in accordance with Good Documentation Practices (ALCOA+).
- Ability to read P & ID drawings and schematics.
- Ability to lift up to 40 pounds.
- This position requires the completion of a Post Offer exam
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Skills / Preferences:**

- Associate degree in Electronics Technology or equivalent experience in electrical and/or instrumentation work.
- Experience installing, troubleshooting, repairing, and maintaining process instrumentation (e.g., temperature, pressure, flow, and automatic control valves).
- Willingness to work scheduled and call-in overtime as needed.
- Ability to work outdoors and tolerate seasonal temperature variations in both summer and winter conditions.
- Proficiency in basic use of Microsoft Office tools (e.g., Word, Excel).

**Additional Information:**

- This position requires some shift work. Temporary shift changes are possible
- Hazardous operations exist within Utilities, involving acid, steam, caustic, chlorine, high pressure, and high temperatures. Personal protective equipment is required.
- Awkward positions, cramped quarters, ladders, and scaffolding work will be required at times.
- This position requires working on summer and year-end company breaks

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

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

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

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

$21.27 - $41.25

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

\#WeAreLilly

Associate Director - Quality Assurance - Device Assembly

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

**Organization Overview**

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. .

**Position Overview**

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance leaders to support our growth in Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Associate Director, Quality Assurance (QA) – Device Assembly (DA), is responsible for staffing, training, and leadership of the quality assurance group supporting the start-up of combination product device assembly and operations at the Kenosha site. This individual is responsible for quality oversight of process development, operational readiness, qualification, and validation of the facility and its associated equipment. The Associate Director will help build a strong quality culture at the site and lead the QA team ensuring robust oversight and support of the ongoing operation as well as the site inspection readiness agenda.

**Responsibilities**

- Support the Sr. Director, QA, in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site quality operations in Device Assembly and Packaging (DAP).
- Support the site to ensure a safe work environment including supporting and leading safety efforts for the quality team.
- Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures for DAP.
- Build a diverse and capable site organization to provide quality oversight and ensure compliance with area procedures and controls for device assembly.
- Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
- Supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment.
- Engage team and delegate to achieve results through others to deliver according to plan.
- Manage multiple priorities in a fast-paced environment and deliver in accordance with established due dates.
- Demonstrate flexibility with quick response as priorities change or issues arise.
- Partner with production and design organization to ensure 24/7 Quality oversight and support.
- Engage and support Operational Excellence initiatives for monitoring performance and continuously improving the operation.
- Review and approve GMP documentation including qualification/validation protocols and reports, procedures, deviations, technical reports, change controls, for DA operations.
- Network with global and other DA sites to understand best practices, share knowledge.
- Work cross-functionally with the area process teams/flow team for metrics reviews, operational support, and issue/deviation management.
- Set area human resource and business plan goals.
- Participate in tactical and strategic business planning.
- Communicate on project and production status.
- Define, lead and/or support inspection readiness activities for operations and interact with Regulatory agencies during inspections.

**Basic Requirements**

- Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
- Minimum 5 years’ experience in pharmaceutical leadership with QA experience, including leading or working effectively with a cross-functional group
- Minimum 5 years’ experience directly supporting a pharmaceutical manufacturing operation (preferably device assembly operations)
- On-site presence required

**Additional Skills/Preferences**

- Strong knowledge of Quality Management Systems and applicable regulatory requirements
- Previous regulatory inspection readiness and inspection execution experience
- Previous facility or area start up experience
- Previous equipment qualification and process validation experience
- Previous experience with SAP or other inventory management systems
- Previous experience with highly automated combination products, packaging, and warehouse operations
- Previous experience with Manufacturing Execution Systems and electronic batch release
- Previous experience with automated material movement (central palletizing operation, automated warehousing)
- Previous experience with deviation and change management systems such as Veeva
- Excellent interpersonal, written and oral communication skills
- Strong technical aptitude and ability to train and mentor others
- Demonstrated technical writing skills
- Demonstrated problem-solving and decision-making skills

**Additional Information:**

- Flex hours possible
- Primary location is Kenosha, Wisconsin
- Ability to travel (approximately 10-20 %)
- Ability for Short Term Assignment (6-9 Months) in a Device Assembly and Packaging site prior to starting the role

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

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

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

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

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

$123,000 - $198,000

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

Lead Maintenance Technician - PAR (Night Shift)

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

**Organization Overview:**

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

**Position Description:**

The focus of the Lead Maintenance Technician is to provide maintenance expertise to service, repair, and maintain process and utility of pharmaceutical manufacturing equipment currently in service.

The Lead Maintenance Technician is expected to understand the needs and requirements of the customer (Operations); must be able to work effectively with customers, handle customer questions with tact and understanding while displaying good customer service.

**Responsibilities:**

- This role is expected to improve equipment uptime, line efficiency, and increase overall equipment effectiveness in a production environment by condition monitoring, troubleshooting, and assisting in engineering changes.
- Must possess a good mechanical aptitude to troubleshoot and repair equipment while, following departmental rules, regulations, and GMP/GDP standards.
- Must be willing to work with safety as a primary focus and abide by applicable safety procedures and practices.
- Troubleshoot the root causes of machine problems (e.g., excessive vibration or temperature, bearing failures, abnormal noises, and poor performance).
- Perform repairs and overhaul equipment (e.g., gear boxes, pumps, blowers, fans and drives) to include disassembly, setting tolerances, aligning, and resetting timing (e.g., air compressors, vacuum pumps)
- Setup equipment to design specifications (e.g., timing, leveling, alignment)
- Must possess the ability to plan and schedule urgent or emergency tasks and effectively delegate these responsibilities to a team of maintenance technicians.
- Must have the ability to quickly and accurately diagnose the root cause of a problem and implement the proper corrective actions to minimize downtime.
- Must accurately write, review, workflow, and document actions taken to repair the equipment in the CMMS program.
- Willing to assist in areas outside of their primary responsibility and learn other skills, as required.

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

- High school diploma/GED
- Minimum 5 Years of applicable maintenance experience
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Must satisfy background check and drug screening requirements.

**Additional Preferences:**

- Must be able to speak, read and write English at a sufficient level to communicate technical and business information effectively.
- Must be able to effectively use business software programs, such as, Maximo, Microsoft Outlook, Microsoft Office Suite and other required software programs.
- Must be able to effectively work in a team environment.
- Physical considerations include the ability to work with or around equipment, climb ladders and stairs and use PPE (Personal Protective Equipment). He/she may be exposed to harsh weather conditions as part of the job.
- Good, all-around hands-on experience with repair of equipment.
- Use basic trouble shooting equipment such as multi-meters, calipers etc.

**Additional Information:**

- Overtime may be required during shutdowns, emergency situations, or periods of heavy workloads.
- The Lead Maintenance Technician will work in and around potentially dangerous and hazardous equipment, powders, liquids and gases. Safety is paramount for this position.
- **Night Shift Role**. Will start out M-F 0730-1530 until fully trained. Will transition to a night shift 12-hr 2-2-3 (1800 to 0600) schedule in the future.
- Relocation assistance is not offered at this time.

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

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

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

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

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

$33.89 - $49.71

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

North Carolina

Sr. Principal Associate - QC Analytical Equipment Support

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 monoclonal antibodies, and bioconjugates in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a 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.*

**Position Overview:**

This role ensures the reliability and performance of analytical laboratory equipment by overseeing maintenance, calibration, and troubleshooting activities across a range of instruments. It also supports equipment lifecycle management by coordinating installations, qualifications, and vendor interactions to maintain compliance and readiness for routine testing.

This position is a recognized expert who makes key technical decisions impacting multiple teams, leads the resolution of highly complex challenges, and influences technical strategy across functions. The role delivers innovations with cross-functional impact, leads significant initiatives, mentors outside their own discipline, and serves as an effective supporter of culture change.

**Responsibilities**:

- Manage routine and corrective maintenance, scheduled calibrations, and preventative maintenance on analytical laboratory instruments such as HPLC systems, spectrophotometers, balances, and incubators to ensure optimal working conditions.
- Monitor equipment performance, diagnose technical issues, execute first-line repairs, and serve as the on-site point person for vendor field service engineers and global support teams.
- Collaborate on the installation and qualification of new equipment through IQ/OQ/PQ activities, support change controls with technical input, and ensure instruments are properly requalified before release back to routine use.
- Execute all Quality Control activities in a timely manner, in compliance with applicable SOPs, methods/protocols, good documentation practices, data integrity standards (ALCOA+), cGMPs, EHS requirements, chemical hygiene, and biosafety guidelines, maintaining an ongoing state of inspection readiness and providing support during audits and inspections as requested.
- Identify and escalate atypical results and potential deviations, participate in root cause investigations and corrective/preventive actions, contribute to cross-functional teams and continuous improvement initiatives, and maintain training competencies to ensure only qualified work is performed.
- Lead QC analytical equipment onboarding for the new Richmond site, including defining instrument needs based on planned testing scope, selecting instruments from the AIQ marketplace, coordinating procurement and installation, and ensuring all equipment is fully qualified (IQ/OQ/PQ) and available for use prior to support site startup and routine testing.

**Basic Requirements:**

- Minimum of a bachelor's degree in a science, Engineering, or a related discipline.
- 7+ years of experience supporting analytical equipment within a GMP-regulated QC environment.
- 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:**

- Prior experience performing preventive maintenance, calibration, and corrective maintenance on a broad range of QC analytical instruments (e.g., HPLC, GC, UV-Vis, balances, pH meters, dissolution apparatus, icIEF, capillary electrophoresis, PCR) in a GMP-regulated laboratory.
- Breadth and experience across technologies leveraged in a large molecule GMP laboratory.
- Demonstrated ability to troubleshoot instrument malfunctions, perform first-line repairs (e.g., lamp replacement, pump seal changes, flow cell cleaning), and effectively escalate complex issues to vendor field service engineers.
- Hands-on experience supporting equipment qualification activities (IQ/OQ/PQ), including coordination with validation teams, execution of qualification protocols, and post-repair requalification prior to returning instruments to routine use.
- Working knowledge of equipment lifecycle management practices, including change control authorship, equipment logbook documentation, calibration scheduling, and asset management within a CMMS or similar system.
- Experience acting as an on-site liaison with vendor service engineers during instrument repair, calibration, or qualification visits, ensuring all work is performed safely, documented properly, and compliant with site GMP requirements.
- Proficient in good documentation practices (GDP) and data integrity principles (ALCOA+).
- Collaborated in document drafting and execution of GMP instrument/software qualifications with solid quality and delivery
- Proven ability to communicate and collaborate effectively with cross-functional teams.
- Implemented data integrity solutions to align with Part 11 and PICS requirements and trends.

**Additional Information:**

- Position Location: US: Richmond VA
- Travel Percentage (%): Short-term assignment at another Lilly facility outside of Richmond may be required for onboarding. Minimal travel (10% or less) is expected after onboarding.
- Shift Information: May include on-call support. Position may include after-hours and company shutdown coverage.

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

$101,250 - $169,400

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

Virginia

Post-Doc Scientist – Parenteral Product Network – TSMS Sterility Assurance and Microbiology Support

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.

**Company 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 39,000 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. #WeAreLilly

**Organization Overview:**

Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing to create a new technical services laboratory capability in Indianapolis, Indiana. This new capability will be used to support the entire Lilly operational network as well as evaluate and develop new technologies that will enable Lilly to be an industry leader and enhance our service to patients.

**Position Title**: Post-Doc Scientist – Parenteral Product Network – TSMS Sterility Assurance and Microbiology Support

**Pay Grade Level**: R0

**Job Function**: TS/MS

**Position Brand Description:**

Post-Doctoral Sterility Assurance and Microbiology Scientists at Lilly are responsible for:

- Ensuring reliability of our manufacturing systems
- Searching for and implementing continuous improvements
- Driving technical projects
- Maintaining our processes in a state of compliance with US and global regulations
- Designing and developing improved Sterility Assurance and Applied Pharmaceutical Microbiology processes and controls

The position is a Post-Doctoral scientist position in the Technical Services/Manufacturing Science (TS/MS) organization. The position will provide technical and scientific support within a dynamic manufacturing environment for aseptic manufacturing and laboratory methods. The successful candidate will be responsible for designing and executing experiments to advance technical capability associated to sterility assurance and applied pharmaceutical microbiology both in a manufacturing and laboratory environment.

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

**Key Objectives/Deliverables**

- Work closely with site and cross-functional SMEs to drive alignment. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
- Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and dissemination of the knowledge across the network.
- Provide mentoring leadership to site SMEs to help continue to build capability and talent, particularly at the newer sites or where deep technical expertise is lacking.
- Building, maintaining, and growing capability across the organization in the sterility assurance space
- Benchmark industry trends and new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practices.
- Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit-for-purpose for robust and compliant commercial manufacturing.
- Develop appropriate laboratory models for potential manufacturing solutions related to Sterility Assurance.
- Design, conduct, and analyze statistically-designed experiments.
- Strong technical writing and documentation of all work in an appropriate manner.
- Mentor lab associates to enhance their technical capabilities.
- Ability to work well independently and collaboratively.

**Basic Requirements:**

- Ph.D. in scientific disciplines of Microbiology, Biology, Molecular Biology, Biochemistry or related fields.
- Demonstrated experience and proficiency in the areas of microbiology, molecular biology and/or aseptic operations
- Requires a record of publication in peer reviewed journals and presentations / posters at scientific conferences.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Preferences:**

- This Post-Doctoral Scientist position is not permanent. It is for a fixed duration of two years with potential to extend to 3 years and for maximum of up to 4 years. You will have opportunities to apply for full time positions after your duration is complete.
- Self-motivated with the ability to work effectively independently, as well as collaboratively in teams.
- Strong scheduling and organizational skills.
- Written and oral communication skills.
- Proficiency in data analysis.
- Ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities.
- Understanding of the scientific method and scientific principles of microbiology.
- Understanding of general laboratory safety expectations.
- Minimal Travel Required
- Strong problem solving and communication skills.
- Prior laboratory work experience and experience with general microbiology laboratory testing techniques and practices.
- Effective time management

**Education Requirements:**

- Ph.D. in scientific disciplines of Microbiology, Biology, Molecular Biology, Biochemistry or related fields.

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

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

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

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

$58,000 - $123,200

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

\#WeAreLilly

Sr. Principal Associate for Analytical Quality Assurance - 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.

**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. 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 Sr. Principal Associate for Analytical Quality Assurance ensures that laboratory activities conducted in the Lilly Medicine Foundry and with external partners are carried out in accordance with global and site quality standards and/or are following current Good Manufacturing Practice (cGMP). This role is responsible for assuring the laboratory maintains a state of control with regards to the generation, reporting, and maintenance of analytical data.

As the Foundry is currently in design and construction, this position will provide Quality oversight for the detailed design and quality processes related to GMP testing and analytical development as well as qualification support for analytical methods and instrumentation. The position is responsible for ensuring that the quality management system is established and adhered to for this area.

**Responsibilities**

- Provide quality oversight in Analytical testing, namely: molecule and modality support, qualification of new contract labs, audit support, quality system ownership, leading compliance projects for analytical within the Foundry, and quality assessments of quality documentation (e.g., deviations, change records).
- Provide quality oversight of method verification, qualification, and validation activities.
- Ensure that appropriate quality systems are in place and are being utilized. Facilitate quality improvement initiatives, and the implementation of new quality standards.
- When necessary, evaluate potential impact of incidents on quality of materials, or the integrity of data.
- Ensure appropriate investigations are conducted for deviations, stability failures and out of specification (OOS) results. Review and approval of the corresponding documentation.
- Perform Quality Assurance review and/or approval /rejection of GMP documentation and ensure that review/approval by appropriate technical experts has occurred.
- Be available for consultation on quality-related issues as needed.
- Network with Lilly quality organizations in the implementation of quality laboratory systems and share best practices.
- Promote a positive quality culture and oversee quality presence in the respective laboratory areas.
- Identify and lead process improvement projects impacting multiple business areas.

**Basic Requirements:**

- Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field with a minimum of 5 years technical laboratory experience. Quality assurance experience in the pharmaceutical industry, preferred.
- Relevant industry experience in highly paced working environments. Relevant experience of working on large-scale capital project deliveries is highly desirable.
- Strong knowledge of analytical method development and validation.
- Strong knowledge of the current GMP expectations and application of quality management systems in execution.
- Minimum 5 yrs of experience in laboratories and analytical testing.
- 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:**

- Ability to manage in a dynamic environment. Flexibility to adjust quickly and effectively to frequent change and altered priorities.
- Ability to provide input and influence decision making for complex technical issues.
- Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.
- Experience with networking across industry, such as with industry groups or committees.
- Success in coaching and mentorship.
- Ability to establish key relationships and influence peers and business partners.
- Strong communication skills.
- Ability to identify and prioritize issues, develop, and implement solutions.
- High learning agility and ability to deal with ambiguity and uncertainty. Capability to drive and design Key Performance Indicators (KPIs), metrics, and data analysis

**Other Information:**

- Initial location at Parkwood West, Carmel, Indiana.
- Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.

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

\#WeAreLilly

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

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

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

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

$65,250 - $169,400

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

\#WeAreLilly

Senior / Principal Associate QA API External 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.

**Job Summary:**

Eli Lilly and Company is seeking a highly motivated and experienced Senior / Principal Associate QA API External Manufacturing to ensure the quality and compliance of externally manufactured Active Pharmaceutical Ingredients (APIs) in accordance with cGMP regulations and company standards. This role will involve significant oversight and collaboration with external manufacturing partners.

**Job Responsibilities:**

\* Serve as the primary Quality Assurance point of contact for assigned API external manufacturing sites, fostering strong collaborative relationships.

\* Review and approve manufacturing documentation, including master batch records, executed batch records, deviations, investigations, CAPAs, change controls, and OOS reports, to ensure cGMP compliance and product quality.

\* Participate in and lead quality audits of external manufacturing partners to assess compliance with cGMPs, regulatory requirements, and internal quality systems.

\* Oversee and approve critical quality events, including significant deviations, investigations, and CAPAs, ensuring timely and effective resolution.

\* Collaborate with internal cross-functional teams (e.g., Supply Chain, Regulatory Affairs, Technical Services) to support new product introductions, technology transfers, and continuous improvement initiatives at external manufacturing sites.

\* Monitor key quality metrics and performance indicators for assigned external manufacturers, identifying trends and implementing corrective actions as needed.

\* Contribute to the development, implementation, and maintenance of quality agreements with external manufacturing partners.

\* Ensure all externally manufactured APIs meet Eli Lilly and Company's quality standards and regulatory requirements for release.

\* Support regulatory inspections and provide responses to regulatory inquiries related to external manufacturing activities.

\* Maintain current knowledge of cGMP regulations (e.g., FDA, EMA) and industry best practices relevant to API manufacturing and external supply chain quality.

**Job Qualifications:**

\* Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline.

\* Minimum of 5 years (Senior Associate) or 8 years (Principal Associate) of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry, with a strong focus on API manufacturing and/or external supply chain quality.

\* In-depth knowledge of cGMP regulations (e.g., 21 CFR Part 210/211, ICH Q7) and international quality standards applicable to API manufacturing.

\* Proven experience in auditing external manufacturing sites and managing quality events (deviations, investigations, CAPAs).

\* Strong understanding of analytical testing methods, stability programs, and release criteria for APIs.

\* Excellent communication, interpersonal, and negotiation skills, with the ability to effectively collaborate with diverse internal and external stakeholders.

\* Demonstrated ability to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast-paced environment.

\* Strong problem-solving and decision-making abilities with a keen attention to detail.

\* Proficiency in English; additional language skills are a plus.

\* Ability to travel domestically and internationally as required (up to 25%).

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

$65,250 - $169,400

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

AVP - Global ATMP Quality

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 Global ATMPS (Advanced Therapy Medicinal Products) Quality Leader provides administrative and technical leadership for Cell and Gene Therapy (CGT) quality across the Lilly enterprise. This role is responsible for establishing and executing the quality strategy for CGT modalities — including AAV gene therapy, cell therapy, and LNP-based platforms — from clinical development through commercialization. The individual provides oversight of quality assurance and quality control functions for Product Research and Development, the LP2 Lebanon facility, external collaboration partners / contract manufacturers and across acquired company quality organizations, ensuring compliance with Global Quality Standards (GQS), current Good Manufacturing Practices (GMP), and applicable regulatory requirements.

This leader will build and scale a streamlined ATMP quality organization with deep modality expertise, providing quality system, regulatory submission, and inspection support to enable seamless clinical and commercial supply. The role collaborates with Quality, Product Research and Development (PR&D), LRM (Lilly Regenerative Medicine), Manufacturing, Technical Services/Manufacturing Sciences (TS/MS), Device Development, Regulatory and external collaboration partners to ensure quality and compliance requirements are met across internal sites and the external CDMO network. The organization is designed to be scalable to accommodate additional modalities as the portfolio evolves.

**Key Objectives/Deliverables:**

**1. Quality Functions and Systems Oversight**

Responsible for the management oversight of the GMP QA and QC units supporting CGT modalities, including the LP2 commercial manufacturing site and acquired company quality organizations. Collaborate with PR&D, LRM, Manufacturing, TS/MS, Device Development, Regulatory, Global Quality Groups, CDMOs, suppliers, and analytical service providers to ensure compliance is met and maintained. Lead improvement initiatives related to quality systems, implementation of new Quality Standards, and monitoring the effectiveness of the Quality System. Ensure cGMP compliance through establishment and utilization of appropriate quality systems tailored to the unique requirements of CGT manufacturing, while considering additional modalities as the portfolio evolves. Define strategies from facility design through commercialization ensuring alignment with GQS, cGMP, and regulatory requirements. Provide key support for business development activities including quality due diligence for CGT-related acquisitions and partnerships. Serve as the accountable quality governance lead for CGT, holding final quality decision rights on CGT quality matters — including quality sign-off of CGT regulatory submissions (e.g., IND, BLA, MAA CMC/quality content), approval of the CGT quality strategy and quality systems, and qualification/disqualification decisions for CDMOs, suppliers, and external collaboration partners.

**2. Quality Leadership and Modality Expertise**

Provide quality oversight and guidance for CGT modalities across the enterprise, serving as the primary point of contact with senior management for escalation of quality issues. Support and advise business personnel across functional areas including Development, LRM, TS/MS, Manufacturing, Device Development and Manufacturing Quality. Ensure appropriate decisions are made with regard to escalated issues. This includes ensuring that QA review and/or approval occurs for various GMP documents including qualification documents, change controls, specifications, stability protocols, deviations, OOS/OOT results, batch release (API and drug product), and audit-related documents in a timely fashion to support both clinical trial and commercial supply needs. Provide guidance on facility design, commissioning and qualification, asset verification, and process validation for CGT manufacturing facilities.

**3. Organization Development and People Leadership**

Responsible for building, scaling, and leading the Global CGT Quality organization, including direct reports at the M3, R5–R8 levels and integration of acquired company quality leads. Develop QA/QC personnel to ensure that site quality units can maintain a state of compliance with all quality expectations and foster a quality culture. Manage resourcing plans, audit plans for internal and external sites, and ensure sites remain qualified to execute their operations under cGMP. Develop people through performance management, development plans, coaching, mentoring, and challenging assignments. Establish and maintain appropriate QA and QC functionality, sufficiently capable through a combination of education, experience, and training to execute roles and responsibilities across analytical stewardship (LNP, AAV), batch release, supplier/material QA, clinical manufacturing QA, and commercial QA/QC functions. Represent Lilly externally within the ATMP quality community — participating in industry conferences, forums, and consortia — to monitor emerging trends, share best practices, and keep the organization at the leading edge of ATMP quality.

**4. Compliance, Regulatory Liaison, and Audit Readiness**

Serve as liaison between Lilly and regulatory agencies for CGT quality matters and provide leadership during regulatory inspections at designated sites. Ensure overall support and logistics for internal and external audits. Partner with sites to maintain a state of inspection readiness and ensure coordination and preparation of pre-approval inspections. Author/approve responses and commitments made to address inspection findings and communicate/escalate issues when appropriate. Provide quality system and regulatory submission support to enable seamless clinical and commercial market supply. Ensure alignment between corporate and site quality standards and commitments across the CGT network.

**5. Strategic and Business Planning**

Provide budget and strategic/business planning oversight for the CGT quality organization. Participate in site business and strategic planning, review metrics, and develop Quality Plans for continuous improvement. Leverage technology and data governance to advance quality within the CGT network. Ensure robust integration of quality operations for acquired company assets, establishing efficient business processes that foster productivity across a growing and evolving organization. Design and set quality objectives aligned with the CGT portfolio’s clinical and commercial milestones.

**Minimum Requirements:**

- Minimum of a Bachelor’s Degree in a science-related field such as Chemistry, Biological Sciences, Microbiology, Engineering, or related Life Sciences.
- Minimum of 15 years of experience in GMP manufacturing or quality operations within the pharmaceutical or biotechnology industry.
- Minimum of 5 years of quality leadership experience with demonstrated ability to manage regulatory communications and inspections.
- Previous QA experience with biologics, cell therapy, gene therapy (AAV), or related advanced therapy modalities.
- Demonstrated strong leadership skills with the ability to build and scale organizations.
- An understanding of the requirements of regulatory agencies such as the FDA, EMA, ICH, and other global health authorities, particularly in the area of cGMPs for biological and advanced therapy medicinal products.
- Demonstrated solid judgment, initiative, and ability to organize and prioritize multiple tasks across a complex, matrixed organization.
- Must exhibit strong teamwork, communication, and interpersonal skills with the ability to influence cross-functionally and externally.

**Additional Preferences:**

- Advanced degree (M.S., Ph.D., or Pharm.D.) in a relevant scientific discipline.
- Previous experience in QC, analytical development, TS/MS, or Regulatory Affairs.
- Direct experience with CGT manufacturing processes including viral vector production, cell processing, and/or LNP formulation.
- Experience with facility design, commissioning, qualification, and process validation for new manufacturing sites.
- Experience with quality integration following mergers, acquisitions, or partnership onboarding.
- Demonstrated technical writing ability and proficiency with quality management systems.
- Experience leading geographically distributed teams across multiple sites.

**Education Requirements:** Minimum of a Bachelor’s Degree in a science-related field such as Chemistry, Biological Sciences, Microbiology, Engineering, or related Life Sciences.

**Other Information:**

- Travel: approximately 15–20%
- Position is based in Indianapolis with periodic presence required at the Lebanon, IN (LP2) facility and travel to acquired company sites 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

$241,500 - $354,200

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

\#WeAreLilly

Novo Nordisk

Maintenance Technician II - Technical Support

**About the Department**

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

What we offer you:

• Leading pay and annual performance bonus for all positions

• All employees enjoy generous paid time off including **14 paid holidays**

• Health Insurance, Dental Insurance, Vision Insurance – effective day one

• Guaranteed 8% 401K contribution plus individual company match option

• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave

• Free access to Novo Nordisk-marketed pharmaceutical products

• Tuition Assistance

• Life & Disability Insurance

• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Improve systems & equipment reliability in assigned process area, reduce system/equipment downtime associated with assigned process & support operation of assigned process.

**Relationships**

Reports to Manager/Supervisor Technical Support.

**Essential Functions**

- Work in a safe & environmentally responsible way
- Actively improve performance & reliability of process equipment
- Restore function to equipment in an effective & technically correct manner
- Actively lead Event Response
- Plan & perform corrective & preventative maintenance on assigned process
- Monitor performance & trends, & provide action plans for assigned process(s)
- Support & implement system/equipment reliability improvement projects
- Support & assist in training & coaching of process operations
- Record & review maintenance & repair data in BPR’s & associated forms
- Review & coach the use of SAP to include Work Order oversight & completion
- Other accountabilities, as assigned.

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Ability to be on feet for up to a 12-hour shift. May require corrected vision to 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. Occasionally performs critical job functions in extremely cold work environments. Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment. Ability to work in loud noise environments with hearing protection. Occasionally works in outdoor weather conditions. Able to pass a driving exam for powered industrial trucks. Does not require a valid driver’s license.

**Qualifications**

- Education: Associate's Degree in relevant field, or equivalent military training or industrial training (which includes a thorough understanding of mechanical, electrical & control systems) required
- Minimum of five (5) years of relevant work experience required
- Knowledgeable in the following systems: Compressed Air, Electro-Mechanical controls, Electrical, Mechanical, Instrumentation & robotics required
- Ability & experience with automated records systems such as SAP, schematics, wiring diagrams & other technical documents required
- Computer literacy required
- Knowledge & application experience of various troubleshooting strategies required
- Organization/Planning: Support planning & execution of process functions & lead coordination of planned & corrective maintenance activities to ensure successful process performance preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Quality Control Instrument Area Specialist - DPM DU

**About the Department**

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including **14 paid holidays**
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Works closely with Laboratory personnel to support repairs, preventive maintenance & calibration of laboratory instrumentation. Schedule resources as related to third party instrument services. Responsible for activities related to BMS & alarm handling.

**Relationships**

Reports to Manager, Senior Manager.

**Essential Functions**

- Resource scheduling as related to third party instrument services
- Accurately & legibly records all activities in appropriate documentation. Writes work orders
- Reviews documentation for accuracy & completeness
- Instrument specifications, scheduled maintenance, repair, & calibration
- Identifies & handles deviations per proper procedures for measuring equipment
- Supports cross-functional investigations & participates in systematic problems solving
- Understand & execute GMP & compliance protocols for instrument validation
- Executes work according to schedule & department plan
- Evaluates instrument performance & responds to potential issues
- Contributes to process confirmations
- Maintains training qualifications on time. Supports training others as required
- Follow all safety and environmental requirements in the performance of duties
- Other duties, as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.

**Minimum Qualifications**

- Bachelor’s Degree in Chemistry, Engineering or a relevant field of study from an accredited university required with a minimum of five (5) years of intense laboratory instrumentation experience in the pharmaceutical industry required
- May consider an Associate’s Degree in Chemistry, Engineering or a relevant field of study from an accredited university with a minimum of seven (7) years of intense laboratory instrumentation experience in the pharmaceutical industry required
- May consider an High School Diploma (GED) with a minimum of nine (9) years of intense laboratory instrumentation experience in the pharmaceutical industry required
- Laboratory instrument calibration, maintenance & repair experience required
- High attention to detail required
- Excellent customer service skills
- Demonstrated high level of organization in task management, as well as logical planning for task execution & follow-up required
- Demonstrated experience in systematic approach to problem solving & troubleshooting required

**Preferred Qualifications**

- Experience with LIMS & lab automation software, preferably Waters Empower preferred
- Extensive experience with MS Office products preferred
- Familiarity with SAP PM module and SAP QM module a plus

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.