Director, Analytical Chemistry - Peptides

Role: Lead analytical scientist specializing in peptide drug substance and drug product development within Lilly's Bioproduct Research and Development (BR&D) organization. Objectives: Drive analytical strategies to support formulation, clinical trials, regulatory submissions, and commercialization of peptide therapeutics. Responsibilities: lead analytical efforts, develop and justify specifications, author regulatory documents (IND/CTA, BLA/NDA), ensure method transfer to manufacturing, and mentor staff. Qualifications: Ph.D. in analytical or bioanalytical chemistry with 5+ years (or B.S. with 15+ years, M.S. with 10+ years) industry experience; expertise in peptide analytics, control strategies, and regulatory strategy development; proven experience with method transfer and global filings. Preferred skills include technical innovation, project management, leadership, and collaboration. High-value specifics: focus on peptide biologics, late-stage development (IND/regulatory filings), and global regulatory engagement. Location: Indianapolis, IN, with travel up to 15%. The role emphasizes cross-functional collaboration, technical innovation, and regulatory acumen in a GxP environment.