Eli Lilly and Company
Advisor Projects & Strategy Analytical GMP Laboratories Lilly Medicine Foundry
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
Position Summary
The Advisor/Sr Advisor of Project & Strategy for Analytical GMP Laboratories will lead clinical manufacturing and analytical strategy for GMP testing laboratories at the Lilly Medicine Foundry. This role drives phase-appropriate, risk-based analytical strategies from development through GMP execution, oversees strategic planning across CMC analytical deliverables, and partners cross-functionally to align analytical strategy with compliance, capability build, and digital enablement. Key Responsibilities
Strategic Leadership & Analytical Planning
Define and lead phase-appropriate, risk-based analytical strategies to support clinical manufacturing.
Develop integrated method readiness strategies, including validation and transfer across multiple modalities.
Oversee CMCanalytical activities, specifications, stability strategies, and lifecycle elements.
Digital Enablement & Technology Advancement
Support digitalization initiatives and implementation ofnew technologiesto enhance analytical workflows.
Drive adoption of PAT, automation, and high-throughput approaches for efficiency and compliance.
Continuous Improvement & Lifecycle Management
Champion continuous improvement initiatives and analytical lifecycle performance metrics.
Ensure alignment with GMP, ICH guidance, and regulatory frameworks throughout the product lifecycle.
Cross-Functional Collaboration
Partner with QA, QC, Manufacturing, Engineering, and R&D to ensure analytical strategies support clinical and commercialobjectives.
Act as a key liaison for technology transfer and method strategy across Foundry operations.
Minimum Qualifications
MS or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline.
10+ years of experience in analytical development, GMP laboratories, or CMC functions.
Strong understanding of ICH guidance, GMP principles, lifecycle management, and regulatory frameworks.
Additional Skills and Preferences
Proven cross-functional leadership experience.
Experience across synthetic and biological modalities.
Familiarity with PAT, automation, and high-throughput workflows.
Continuous improvement mindset withdemonstratedCI experience.
Strong strategic thinking, influence, and stakeholder management skills.
Other Information:
Initial location at Lilly Technology Center, Indianapolis.
Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.
Flexibility to work from Indianapolis (or other Lilly sites) may berequiredthroughout 2026and 2027.
Position requireson-site presence, 8-hour days, five days per week, with flexibility to support activities during shutdowns, weekends, etc.
0-10% travelrequired.
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 ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
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The Advisor/Sr Advisor of Project & Strategy for Analytical GMP Laboratories will lead clinical manufacturing and analytical strategy for GMP testing laboratories at the Lilly Medicine Foundry. This role drives phase-appropriate, risk-based analytical strategies from development through GMP execution, oversees strategic planning across CMC analytical deliverables, and partners cross-functionally to align analytical strategy with compliance, capability build, and digital enablement. Key Responsibilities
Strategic Leadership & Analytical Planning
Define and lead phase-appropriate, risk-based analytical strategies to support clinical manufacturing.
Develop integrated method readiness strategies, including validation and transfer across multiple modalities.
Oversee CMCanalytical activities, specifications, stability strategies, and lifecycle elements.
Digital Enablement & Technology Advancement
Support digitalization initiatives and implementation ofnew technologiesto enhance analytical workflows.
Drive adoption of PAT, automation, and high-throughput approaches for efficiency and compliance.
Continuous Improvement & Lifecycle Management
Champion continuous improvement initiatives and analytical lifecycle performance metrics.
Ensure alignment with GMP, ICH guidance, and regulatory frameworks throughout the product lifecycle.
Cross-Functional Collaboration
Partner with QA, QC, Manufacturing, Engineering, and R&D to ensure analytical strategies support clinical and commercialobjectives.
Act as a key liaison for technology transfer and method strategy across Foundry operations.
Minimum Qualifications
MS or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline.
10+ years of experience in analytical development, GMP laboratories, or CMC functions.
Strong understanding of ICH guidance, GMP principles, lifecycle management, and regulatory frameworks.
Additional Skills and Preferences
Proven cross-functional leadership experience.
Experience across synthetic and biological modalities.
Familiarity with PAT, automation, and high-throughput workflows.
Continuous improvement mindset withdemonstratedCI experience.
Strong strategic thinking, influence, and stakeholder management skills.
Other Information:
Initial location at Lilly Technology Center, Indianapolis.
Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.
Flexibility to work from Indianapolis (or other Lilly sites) may berequiredthroughout 2026and 2027.
Position requireson-site presence, 8-hour days, five days per week, with flexibility to support activities during shutdowns, weekends, etc.
0-10% travelrequired.
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 ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
#J-18808-Ljbffr