Senior Commercial Drug Substance Manufacturing Manager

Role: Senior specialist responsible for overseeing technical and operational aspects of Exelixis' small molecule drug substance manufacturing pipeline at CMOs, ensuring process optimization, validation, change management, and transition from development to commercial stages. Responsibilities: manage third-party API and raw material manufacturers, oversee process qualifications, validations, deviations, and investigations; lead CMO onboarding, quality performance reviews, and facilitate technology transfers. Collaborate with QA, logistics, legal, and other departments to ensure compliance and supply continuity; review batch records, approve change controls, and support regulatory documentation including NDAs, MAAs, and INDs. Requirements: BS/BA in chemistry or chemical engineering with ≥9 years (MS/MA) or ≥2 years (PhD) of related experience; extensive experience in cGMP pharmaceutical/biotech manufacturing, especially small molecule APIs; strong knowledge of regulatory and quality standards; proven skills in process development, validation, troubleshooting, and CMO management. HighValue: small molecule APIs, drug substance manufacturing, commercial cGMP environment, process validation, regulatory submissions, 30% domestic travel. WorkSetup: primarily office-based with some time at manufacturing facilities.