Senior Scientist / Associate Director, Drug Product Manufacturing

Role: Oversee commercial drug product manufacturing at contract manufacturing organizations (CMOs), ensuring quality, compliance, and timely delivery for small molecule solid oral dosage forms. Responsibilities: perform batch review and release activities, coordinate investigations of deviations and out-of-specification results, participate in process validations, change controls, and continuous improvement projects, and generate batch genealogy. Collaborate with CMC, Quality Assurance, and Supply Chain teams, serving as a technical liaison with CMOs. Requirements: BA/BS in Life Sciences, Engineering, or related field; 8+ years in pharmaceutical manufacturing with strong knowledge of cGMP, analytical activities, and quality oversight in commercial drug production; experience with solid oral dosage form CMOs; ability to travel up to 30%. High-Value: focus on small molecule solid oral drugs, commercial manufacturing stage, GxP compliance, regulatory oversight, and cross-functional coordination. Work setup: hybrid role based in San Francisco requiring in-office presence 2-3 times per week.