Associate Director, Chemical Engineering

Role: Senior chemical engineering leader managing late-stage development through commercial launch of small-molecule drug substance NX-5948, overseeing external manufacturing and process optimization. Responsibilities: design and scale-up manufacturing routes; oversee equipment qualification, process troubleshooting, and technology transfer at CDMOs; ensure compliance with cGMP/ICH/FDA/EMA standards; review batch records, deviations, and regulatory filings; monitor plant performance and drive process robustness, lifecycle, and cost strategies; mentor scientists and engineers; represent engineering in cross-functional teams. Requirements: Ph.D. in chemical engineering or related field; 5+ years (Ph.D.) or 10+ years (M.S.) industrial experience in GMP drug substance development; expertise in process development, scale-up, validation, equipment evaluation, and CDMO management; knowledge of polymorphism and crystallization; strong regulatory and compliance understanding; excellent communication skills; ability to travel up to 25%. HighValue: small-molecule drug development, late-phase manufacturing, CDMO oversight, regulatory submissions, process engineering, lifecycle management, Brisbane, CA, onsite.