Director, Analytical Chemistry – Genetic Medicines; Analytical Development - BR&D
Eli Lilly and Company
August 12, 2026
On-site
Indianapolis, IN
Operations
Responsibilities:
- Lead analytical efforts for genetic medicine drug substance and drug product development/commercialization (e.g., AAV gene therapy, gene editing, cell-based, RNA-based), including regulatory familiarity.
- Develop analytical methods, justify specifications, design stability studies, author regulatory submissions, and address global 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 to support clinical trials and regulatory submissions.
- Author IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ); monitor regulatory guidance to shape ATMP strategy.
- Provide technical guidance for external network analytical activities; ensure methods are technically sound and fit-for-purpose; execute technology transfer to CRO/CMO and Lilly manufacturing.
- Manage short- and long-term technical agendas/timelines; recommend resources; communicate progress and changes.
Qualifications:
- PhD (Analytical Chemistry/Molecular Biology/Biochemistry/Biology) + 5+ years pharma industry, or MS + 10+ years, or BS + 15+ years.
- Demonstrated experience with analytical control strategy development for late-phase genetic medicine.
- Experience developing global regulatory strategies (submissions, regulatory Q&A, registrations).
- Experience transferring analytical methods into internal/external GMP facilities.
Preferred/Additional Skills:
- Translate innovation to business value; lead complex technical projects; drive cross-functional change; strong influence/negotiation; strong communication.
Additional Information:
- Travel: 0–15%; potential exposure to chemicals/allergens/loud noises.
- Benefits: 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life/death benefits, time off/leave, well-being benefits.
Application instructions:
- If you need accommodation to submit a resume, complete: https://careers.lilly.com/us/en/workplace-accommodation
- Lead analytical efforts for genetic medicine drug substance and drug product development/commercialization (e.g., AAV gene therapy, gene editing, cell-based, RNA-based), including regulatory familiarity.
- Develop analytical methods, justify specifications, design stability studies, author regulatory submissions, and address global 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 to support clinical trials and regulatory submissions.
- Author IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ); monitor regulatory guidance to shape ATMP strategy.
- Provide technical guidance for external network analytical activities; ensure methods are technically sound and fit-for-purpose; execute technology transfer to CRO/CMO and Lilly manufacturing.
- Manage short- and long-term technical agendas/timelines; recommend resources; communicate progress and changes.
Qualifications:
- PhD (Analytical Chemistry/Molecular Biology/Biochemistry/Biology) + 5+ years pharma industry, or MS + 10+ years, or BS + 15+ years.
- Demonstrated experience with analytical control strategy development for late-phase genetic medicine.
- Experience developing global regulatory strategies (submissions, regulatory Q&A, registrations).
- Experience transferring analytical methods into internal/external GMP facilities.
Preferred/Additional Skills:
- Translate innovation to business value; lead complex technical projects; drive cross-functional change; strong influence/negotiation; strong communication.
Additional Information:
- Travel: 0–15%; potential exposure to chemicals/allergens/loud noises.
- Benefits: 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life/death benefits, time off/leave, well-being benefits.
Application instructions:
- If you need accommodation to submit a resume, complete: https://careers.lilly.com/us/en/workplace-accommodation