Associate Director Drug Product Technical Operations

Role: Associate Director, Drug Product Technical Operations, overseeing manufacturing and technical execution of biologic drug products from late-stage development through commercialization. Responsibilities include leading formulation, aseptic fill-finish, process validation, technology transfer, lifecycle management, and regulatory module 3 content, ensuring product quality, regulatory compliance, and supply continuity. The role interfaces with external CMOs, Quality, Regulatory, Supply Chain, and Clinical teams, managing technical governance, documentation, deviations, and inspections. Requirements: Bachelor's in engineering, pharmaceutical sciences, or related field; 8-12+ years in biologics drug product development, manufacturing, or CMC; experience with aseptic fill-finish, process validation, drug transfer, and regulatory submissions. Preferred: expertise with biologic injectables, prefilled syringes, and combination products, along with GMP, validation, deviation management, and external partner oversight. HighValue: biologics, injectable formulations, aseptic processing, process validation, lifecycle management, BLA support, GMP compliance, external manufacturing. Location: Boston, MA preferred; travel not specified.