Sr. Director, Drug Product Dev & Manufacturing (On-site)

Role: Lead formulation and drug product development for small-molecule programs, overseeing process design, tech transfer, CMO management, and regulatory submissions. Responsibilities: define development strategies, establish specifications, ensure GMP compliance, coordinate with internal teams and external CMOs for clinical and commercial manufacturing, author regulatory documentation, and mentor scientists. Qualifications: Ph.D. in Chemistry, Pharmaceutical Sciences, or related field; 10+ years in late-phase, NDA/MAA filing, small-molecule drug product development; extensive GMP manufacturing experience, including spray drying, granulation, and encapsulation; proven CMO management skills; strong knowledge of cGMP, ICH, FDA, EMA standards. Preferred: experience in enabling formulations, global packaging regulations, and international travel (up to 25%). HighValue: small molecules, late-phase (NDA/MAA), formulation development, CMO oversight, regulatory filings. WorkSetup: onsite in South San Francisco, minimum 4 days/week, with domestic and international travel.