Manager, Drug Product Manufacturing

Role: Senior Manager/Manager, Drug Product Manufacturing, overseeing external biologic drug product manufacturing for clinical and commercial supply. Objectives include ensuring reliable production, successful technology transfers, and regulatory compliance across lyophilized biologics. Responsibilities encompass leading external CMO/CDMO relationships, managing manufacturing operations including aseptic filling, lyophilization, inspection, and packaging; coordinating technology transfer from process development through commercialization; reviewing batch records, validation, and change controls; monitoring KPIs for continuous improvement; supporting process validation, scale-up, and launch readiness; and collaborating with cross-functional teams like Quality, Regulatory, Supply Chain, and Process Development. Requirements: Bachelor's or higher in a relevant field, with extensive experience (typically 7+ years) in biologics manufacturing, sterile processing, lyophilization, and GMP operations. Proven expertise in process transfer, validation, and lifecycle management of biologic drug products is essential. Preferred qualifications include experience with clinical and commercial biologic production, regulatory inspections, and project management skills. High-value specifics: biologics, sterile manufacturing, lyophilized products, process validation, cGMP compliance, regulatory liaison, and international travel (~20%). The role reports to the Head of Drug Product, CMC Technical Operations, and involves collaboration with multiple departments and external partners.