Distinguished Scientist, Microbiology

Role: Senior microbiology scientist leading strategic microbiology capabilities for small molecules, biologics, and vaccines in clinical development. Responsibilities: oversee raw material testing, in-process controls, GMP release, stability testing, environmental monitoring, and analytical method transfer; direct microbiology strategy including NGS and rapid microbiological methods; ensure compliance with GMP, lead validation/qualification activities, and support regulatory filings (INDs, NDAs, BLAs). Engage with cross-functional teams (CMC, regulatory, quality, manufacturing) to enable robust product development, regulatory compliance, and lifecycle management. Requirements: Ph.D. in microbiology or related field with 10+ years, or MS with 12+ years, or BS with 16+ years industry experience; expertise in microbiological techniques, analytical development, GMP compliance, and regulatory standards. Preferred: experience with molecular microbiology, viral screening, and advanced microbiology technologies; ability to influence cross-functional initiatives, excellent communication skills. High-Value: focus on microbiology for pharmaceutical development, including biologics, small molecules, and vaccines; involvement in early to late-stage development (IND to post-market); 25% travel; hybrid work setup.