Director, Analytical Chemistry – Genetic Medicines; Analytical Development - BR&D
Eli Lilly and Company
September 02, 2026
On-site
Indianapolis, IN
Operations
Position Responsibilities:
- Lead analytical efforts for genetic medicine (e.g., AAV gene therapy, gene editing, cell-based gene therapy, RNA-based therapies) across drug substance and drug product development, commercialization, and related regulatory requirements.
- Develop analytical methods, justify specifications, design stability studies, author regulatory submissions, and address global regulatory agency questions.
- Implement technical solutions and analytical strategies to enable process development and product understanding; deliver robust control strategies; collaborate across Discovery, Development, and Manufacturing.
- Author IND/CTA and BLA/NDA/MAA submissions and country-specific Response to Questions (RtQ); monitor regulatory guidance to shape regulatory strategy for ATMP programs.
- Provide technical guidance for external-network analytical work; ensure methods are technically sound and fit-for-purpose; execute technology transfer to CRO/CMO and Lilly manufacturing sites.
- Drive adoption of novel analytical technologies; engage external innovation; support group growth via excellence and knowledge sharing.
- Plan/manage short- and long-term development activities; develop technical agendas/timelines; recommend resourcing and communicate progress.
- Use strong communication, organizational, and leadership skills.
Basic Qualifications:
- Ph.D. (Analytical Chemistry, Molecular Biology, Biochemistry, or Biology) + 5+ years pharmaceutical industry experience; or M.S. + 10+ years; or B.S. + 15+ years.
- Experience developing analytical control strategies for late-phase genetic medicine drug substance and drug products.
- Experience developing global regulatory strategies (submissions, regulatory Q&A, and/or product registrations).
- Experience transferring analytical methods into internal/external GMP manufacturing.
Additional Skills/Preferences:
- Translate technical innovation into business value; manage complex technical projects; cross-functional leadership; influencing/negotiation; collaboration and inclusion; prioritize amid ambiguity.
Additional Information:
- Travel: 0–15%; potential exposure to chemicals, allergens, and loud noises.
Application Instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Lead analytical efforts for genetic medicine (e.g., AAV gene therapy, gene editing, cell-based gene therapy, RNA-based therapies) across drug substance and drug product development, commercialization, and related regulatory requirements.
- Develop analytical methods, justify specifications, design stability studies, author regulatory submissions, and address global regulatory agency questions.
- Implement technical solutions and analytical strategies to enable process development and product understanding; deliver robust control strategies; collaborate across Discovery, Development, and Manufacturing.
- Author IND/CTA and BLA/NDA/MAA submissions and country-specific Response to Questions (RtQ); monitor regulatory guidance to shape regulatory strategy for ATMP programs.
- Provide technical guidance for external-network analytical work; ensure methods are technically sound and fit-for-purpose; execute technology transfer to CRO/CMO and Lilly manufacturing sites.
- Drive adoption of novel analytical technologies; engage external innovation; support group growth via excellence and knowledge sharing.
- Plan/manage short- and long-term development activities; develop technical agendas/timelines; recommend resourcing and communicate progress.
- Use strong communication, organizational, and leadership skills.
Basic Qualifications:
- Ph.D. (Analytical Chemistry, Molecular Biology, Biochemistry, or Biology) + 5+ years pharmaceutical industry experience; or M.S. + 10+ years; or B.S. + 15+ years.
- Experience developing analytical control strategies for late-phase genetic medicine drug substance and drug products.
- Experience developing global regulatory strategies (submissions, regulatory Q&A, and/or product registrations).
- Experience transferring analytical methods into internal/external GMP manufacturing.
Additional Skills/Preferences:
- Translate technical innovation into business value; manage complex technical projects; cross-functional leadership; influencing/negotiation; collaboration and inclusion; prioritize amid ambiguity.
Additional Information:
- Travel: 0–15%; potential exposure to chemicals, allergens, and loud noises.
Application Instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation