Sr Director, Analytical Operations

Role: Senior Director of Pivotal and Commercial Biologics Analytical Development, leading structural characterization, comparability strategies, and CQAs for biologics. Responsibilities: oversee a team of ~20 scientists, guide analytical methods development (mass spectrometry, biophysical techniques), establish control strategies for manufacturing changes, build state-of-the-art labs, and support regulatory filings and interactions. Collaborate cross-functionally with Quality, Supply Chain, Manufacturing, and Regulatory teams; ensure compliance with cGMP standards; drive technological innovation; and develop organizational goals. Qualifications: Ph.D. with 12+ years or M.S. with 15+ years in Analytical Chemistry or related biologics fields; extensive experience in biologics analytical method development, control strategies, and regulatory documentation (IND, BLA, PAS); expertise in mass spectrometry, biophysical techniques, high-throughput assays, and cGMP. Preferred: strong leadership skills, strategic vision, collaboration ability, and experience with global biologics development and commercialization. HighValue: biologics, protein-based modalities, late-stage development (post-approval), regulatory filing support, analytical method expertise, team leadership, and technical innovation. WorkSetup: not specified; likely hybrid or onsite given lab leadership responsibilities.