Senior Manager, Process Development and Manufacturing

Role: Senior Manager of Process Development and Manufacturing, focusing on small molecule drug substance development, process scale-up, and CMO coordination. Responsibilities: support and optimize chemical synthesis processes, oversee technology transfers, ensure cGMP compliance, review batch documentation, and contribute to regulatory submissions. Collaborate cross-functionally to ensure seamless transition between development stages and manufacturing sites. Requirements: Ph.D. (3+ years), MS (6+ years), or BS (8+ years) in pharmaceutical/biotech with extensive hands-on experience in process chemistry for small molecules; knowledge of cGMP, ICH, USP standards; experience working with CMOs. Preferred skills include strong technical expertise in drug substance manufacturing and excellent communication skills. HighValue: small molecule APIs, drug substance process development, cGMP compliance, scale-up, technology transfer, regulatory documentation, cGMP manufacturing. WorkSetup: hybrid South San Francisco; no travel specified.