Sr. Director External Manufacturing

Role: Senior Director of External Manufacturing leading strategic and operational oversight of outsourced production for late-stage and commercial small molecule APIs and oral solid dose products. Responsibilities: develop and execute manufacturing strategies; manage CDMO selection, relationships, and performance; oversee technology transfer, process validation, and quality compliance; coordinate global manufacturing network, logistics, and capacity planning; collaborate cross-functionally with R&D, Quality, Regulatory, Supply Chain, and Commercial teams; support regulatory filings and product launches; ensure GMP adherence and continuous improvement. Qualifications: BS in Chemistry, Chemical Engineering, or related; 15+ years in pharmaceutical manufacturing with extensive experience managing external CDMOs; deep expertise in small molecule manufacturing and OSD products; strong knowledge of GMP, validation, quality systems, and global manufacturing networks; proven leadership in late-stage development, PPQ, and commercialization; excellent technical troubleshooting, cross-functional collaboration, and strategic planning skills. Work setup: global travel up to 30%, based in California or Shanghai, with hybrid/remote flexibility.