Manager, Outsourced Manufacturing

Manager, Global External Manufacturing, Small Molecule Drug Substance (DS) Essential Functions Execute the Global External Manufacturing network strategy; manage external manufacturing business execution and supplier performance. Collaborate with functions within and external to PDM to achieve corporate, cross-functional, and departmental goals. Coordinate inter- and intra-company technical transfers; partner with Technical Development and internal sites for technology transfer and validation of new or existing processes/products to identified CMO(s). Manage CMOs to ensure products are manufactured per the registered process and approved Master Production Record. Resolve manufacturing/compliance issues, including deviations, complaints, out-of-specification investigations, Material Review Board investigations, finished product trending, and change control. Drive continuous improvement to reduce cost, improve quality, increase efficiency, and ensure sustainability. May represent manufacturing on cross-functional Development or Commercial CMC teams and proactively manage product strategy across the lifecycle (clinical supply through launch and routine supply, then sunset/divestiture). Basic Qualifications 6+ years of progressively responsible experience in a pharmaceutical/biotech organization. BA or BS degree in science or engineering. MS or MBA may substitute for 2 years of relevant experience; PhD may substitute for 4 years of relevant experience. Preferred Qualifications Experience in drug substance manufacturing and supply chain execution/oversight. Working understanding of cGMP and worldwide regulatory requirements (including ICH guidance). Knowledge of the contract manufacturing organization (CMO) landscape (CMO capabilities/limitations for worldwide drug product manufacturing is a plus). Ability to travel internationally (overnight up to 10%). Exceptional verbal and written communication skills; ability to interact effectively with senior management and CMO organizations. Benefits Company-sponsored medical, dental, vision, and life insurance plans. #J-18808-Ljbffr