Director, Analytical Chemistry – Genetic Medicines; Analytical Development - BR&D

Role: Lead analytical development for genetic medicine (e.g., AAV, gene editing, RNA therapies) drug substances and products, supporting clinical trials, regulatory filings, and commercialization. Responsibilities: develop and justify analytical methods, set specifications, design stability studies, author regulatory submissions (IND/CTA, BLA/NDA/MAA), ensure methods meet regulatory standards, and facilitate tech transfer to manufacturing and CROs. Drive control strategies for late-phase genetic medicines, collaborate across discovery, development, and manufacturing teams, and stay abreast of evolving regulatory guidance. Requirements: Ph.D. in Analytical Chemistry, Molecular Biology, Biochemistry, or Biology with 5+ years (Ph.D.) or 10+ years (M.S.) or 15+ years (B.S.) pharmaceutical/biotech experience; proven expertise in analytical control strategies for genetic medicine products; experience with global regulatory strategies and submissions; technical transfer experience. Preferred: leadership in complex projects, experience managing external partnerships, strong communication, and cross-functional collaboration skills. HighValue: focus on gene therapies, cell-based and RNA-based platforms, late-phase development, and regulatory submissions; travel up to 15%. WorkSetup: onsite in Indianapolis; hybrid options possible.