Senior Director, Quality Control

Role: Associate Director, Chemical Engineering overseeing end-to-end support for bexobrutideg (NX-5948) drug substance from late-stage development to commercialization. Responsibilities: lead process design, optimization, and scale-up of small-molecule manufacturing; manage equipment qualification, troubleshooting, and technology transfer at CDMOs; collaborate with cross-functional teams on process understanding, regulatory documentation, and lifecycle management; ensure compliance with cGMP, ICH, FDA, EMA standards; monitor manufacturing performance and support regulatory filings. Requirements: Ph.D. in chemical engineering or related field with 5+ years (or M.S./B.S. with more extensive experience) in small-molecule drug development, GMP manufacturing, process development, and CDMO management; deep knowledge of process modeling, equipment design, and quality standards; experience with QbD, DoE, regulatory submissions, and process validation. HighValue: late-phase small-molecule development, process scale-up, CDMO oversight, regulatory documentation, cGMP compliance. WorkSetup: onsite Brisbane, CA; travel up to 25%.