Sr. Director External Manufacturing

Role: Senior Director of External Manufacturing responsible for strategic leadership and operational oversight of outsourced manufacturing for late-stage and commercial small molecule APIs and oral solid dose products. Objectives include ensuring reliable, compliant, and cost-effective supply through CDMO partnerships, supporting drug substance, drug product, and packaging/labeling operations. Responsibilities encompass selecting and managing CDMOs, technology transfer, validation, overseeing production, troubleshooting, and maintaining GMP compliance. Facilitates cross-functional coordination with Quality, Regulatory, Supply Chain, and Commercial teams to support clinical and commercial supply chains, including product launches and lifecycle management. Qualifications include 15+ years in pharmaceutical manufacturing with substantial experience managing global CDMOs, deep expertise in small molecule and OSD manufacturing, and knowledge of validation, GMP, and quality systems. Preferred skills include advanced degrees (M.S., Ph.D., or MBA), strong leadership, communication, and cross-functional collaboration abilities, along with experience supporting late-stage development and scale-up. High-value biopharma specifics: focus on small molecules, late-stage development, global manufacturing network, and regulatory compliance. Travel up to 30% globally. The role reports to the VP, Global Manufacturing & Supply Chain, and is based in a hybrid model with international responsibilities.