Director, Analytical Chemistry – Genetic Medicines; Analytical Development - BR&D
Eli Lilly and Company
June 30, 2026
Remote friendly (Indianapolis, IN)
United States
Operations
Position Responsibilities:
- Lead analytical efforts for genetic medicine (e.g., AAV gene therapy, gene editing, cell-based therapies, RNA therapies) across drug substance/product development and commercialization; stay current on regulatory requirements and industry trends.
- Develop analytical methods, justify specifications, design stability studies, author regulatory submissions, and respond to global regulatory agency questions.
- Implement analytical strategies to enable process development and product understanding; deliver robust control strategies; collaborate across Discovery, Development, and Manufacturing.
- Author IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ); monitor emerging regulatory guidance to shape regulatory strategy for ATMP programs.
- Provide technical guidance for external-network analytical work; ensure methods are fit-for-purpose; execute technology transfer to CRO/CMO and Lilly sites.
- Drive adoption of fit-for-purpose/novel analytical technologies; demonstrate learning agility and cross-domain expertise.
- Support team growth; plan/manage short- and long-term development activities, timelines, and resourcing.
- Demonstrate strong oral/written communication, organization, and leadership.
Basic Qualifications:
- Ph.D. (Analytical Chemistry, Molecular Biology, Biochemistry, or Biology) + 5+ years pharma experience, OR M.S. + 10+ years, OR B.S. + 15+ years.
- Required: analytical control strategy development experience for late-phase genetic medicine drug substance/product.
- Prior: global regulatory strategy experience (submissions, regulatory questions, and/or product registration).
- Experience: technical transfer of analytical methods into internal/external GMP manufacturing.
Additional Skills/Preferences:
- Technical depth translating science to business value; manage complex projects end-to-end.
- Lead cross-functional teams; strong influencing/negotiation.
- Strong collaboration and ability to prioritize amid ambiguity.
Additional Information:
- Travel: 0–15%; potential exposure to chemicals, allergens, and loud noises.
- Anticipated wage: $148,500–$257,400; may be eligible for company bonus and comprehensive benefits (e.g., 401(k), insurance, time off, well-being benefits).
- Lead analytical efforts for genetic medicine (e.g., AAV gene therapy, gene editing, cell-based therapies, RNA therapies) across drug substance/product development and commercialization; stay current on regulatory requirements and industry trends.
- Develop analytical methods, justify specifications, design stability studies, author regulatory submissions, and respond to global regulatory agency questions.
- Implement analytical strategies to enable process development and product understanding; deliver robust control strategies; collaborate across Discovery, Development, and Manufacturing.
- Author IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ); monitor emerging regulatory guidance to shape regulatory strategy for ATMP programs.
- Provide technical guidance for external-network analytical work; ensure methods are fit-for-purpose; execute technology transfer to CRO/CMO and Lilly sites.
- Drive adoption of fit-for-purpose/novel analytical technologies; demonstrate learning agility and cross-domain expertise.
- Support team growth; plan/manage short- and long-term development activities, timelines, and resourcing.
- Demonstrate strong oral/written communication, organization, and leadership.
Basic Qualifications:
- Ph.D. (Analytical Chemistry, Molecular Biology, Biochemistry, or Biology) + 5+ years pharma experience, OR M.S. + 10+ years, OR B.S. + 15+ years.
- Required: analytical control strategy development experience for late-phase genetic medicine drug substance/product.
- Prior: global regulatory strategy experience (submissions, regulatory questions, and/or product registration).
- Experience: technical transfer of analytical methods into internal/external GMP manufacturing.
Additional Skills/Preferences:
- Technical depth translating science to business value; manage complex projects end-to-end.
- Lead cross-functional teams; strong influencing/negotiation.
- Strong collaboration and ability to prioritize amid ambiguity.
Additional Information:
- Travel: 0–15%; potential exposure to chemicals, allergens, and loud noises.
- Anticipated wage: $148,500–$257,400; may be eligible for company bonus and comprehensive benefits (e.g., 401(k), insurance, time off, well-being benefits).