Associate Director Analytical Development & Quality Control

Role: Associate Director of Analytical Development & Quality Control at a biopharma focused on immune diseases and cancer therapies, primarily overseeing analytical methods for small molecule drug substances and products. Responsibilities: lead method development, validation, stability studies, and data review; manage reference standards, stability programs, and regulatory documentation (IND/IMPD/NDA/MAA); collaborate with vendors and internal teams to ensure phase-appropriate analytical strategies; contribute to CMC sections of regulatory filings and scientific publications; monitor project progress and ensure timely completion. Requirements: PhD or advanced degree in Chemistry, Pharmaceutics, or related field; 7+ years (PhD) or 10+ years (BS/MS) industry experience in small molecule development; expertise in HPLC, plus techniques like GC, NMR, MS, and solid-state characterization; solid understanding of cGMP, ICH guidelines, validation, and stability management; strong data interpretation, vendor negotiation, and cross-functional collaboration skills; willingness to travel domestically and internationally. High-Value: focus on late-stage analytical development, stability programs, regulatory documentation, and cross-functional leadership in a biotech setting. WorkSetup: on-site South San Francisco; salary $170,000-$200,000.