Associate Director, Process Chemistry

Role: Associate Director of Process Chemistry responsible for leading small molecule drug substance development from preclinical to GMP production. Objectives: ensure robust, scalable, and compliant manufacturing processes; support regulatory submissions; and collaborate across R&D functions. Responsibilities: act as SME for process development, including route scouting, process optimization, solid form selection, and GMP manufacturing; develop control strategies for starting materials, impurities, and specifications; manage CDMO relationships for process transfer and manufacturing; author technical, regulatory, and quality documentation; and support quality systems and compliance. Requirements: PhD, MS, or BS in organic chemistry or related field with 7+ to 12+ years industry experience in small molecule process chemistry; proven success in drug substance development, scale-up, and GMP manufacturing; expertise in analytical techniques (HPLC, MS, NMR, XRPD); strong understanding of cGMP, ICH, FDA, EMA, and USP guidelines; experience managing external partners and regulatory documentation; excellent communication and organizational skills; ability to travel up to 20%. HighValue: small molecule therapeutics, drug substance development, GMP manufacturing, regulatory submissions (IND, IMPD), cGMP compliance, process development, scale-up, cross-functional collaboration. WorkSetup: on-site in South San Francisco, CA, with domestic and international travel.