Director, Genetic Medicine Analytics

BioSpace; Indianapolis (IN); On-site; USD 149,000 - 257,000; Full time

Job summary

Lilly, headquartered in Indianapolis, is seeking candidates with a strong foundation in analytical sciences and genetic medicine to enable clinical trials and regulatory submissions. You will lead analytical strategies, develop methods, and collaborate across Discovery, Development, and Manufacturing.

The role emphasizes cross-functional leadership, regulatory insight, and implementation of robust control strategies for late-stage genetic medicine programs.

Qualifications

• Ph.D. or advanced degree with 5+ years in pharma/biotech development.
• Experience with analytical control strategy for late-phase genetic medicine.
• Global regulatory submissions and responses to questions.
• Technical transfer of analytical methods to GMP facilities.

Responsibilities

• Lead analytical efforts for genetic medicine drug substances and products, aligning with regulatory requirements.
• Develop analytical methods, justify specifications, and design stability studies for filings.
• Author IND/CTA, BLA/NDA/MAA submissions and RtQ responses; monitor regulatory guidance.
• Drive analytical strategies and technology transfer to CRO/CMO and Lilly sites.
• Provide cross-functional guidance and ensure fit-for-purpose methods across teams.
• Champion adoption of novel analytics to strengthen control strategies and product understanding.

Skills

Analytical chemistry

Molecular biology

Biochemistry

Genetic medicine analytics

Regulatory strategy

IND/CTA submissions

Education

Ph.D. in Analytical Chemistry, Molecular Biology, Biochemistry, or Biology

M.S. in Analytical Chemistry, Molecular Biology, Biochemistry, or Biology

B.S. in Analytical Chemistry, Molecular Biology, Biochemistry, or Biology

Job description

Lilly, headquartered in Indianapolis, is seeking candidates with a strong foundation in analytical sciences and genetic medicine to enable clinical trials and regulatory submissions. You will lead analytical strategies, develop methods, and collaborate across Discovery, Development, and Manufacturing.

The role emphasizes cross-functional leadership, regulatory insight, and implementation of robust control strategies for late-stage genetic medicine programs.