Manager, Injectable Products

Role: The Manager, Injectable Products is a technical leader supporting sterile injectable drug products from late-stage development through commercial launch and lifecycle management. Responsibilities include providing subject matter expertise in formulation, filling, lyophilization, and sterile manufacturing processes; leading process validation, technology transfer, and process improvement initiatives; and ensuring regulatory compliance, inspection readiness, and effective lifecycle management. The role involves close collaboration with cross-functional teams such as Manufacturing, Quality, Regulatory, Supply Chain, and external CMOs/CDMOs to ensure manufacturing robustness, quality, and supply continuity. Key focus areas include process characterization, validation, investigations, CAPAs, and risk assessments for biologic and small molecule injectables, supporting global regulatory submissions and inspections. The position requires supporting GMP compliance and continuous process improvements to optimize manufacturing. The candidate must have a BS or MS in a relevant scientific discipline with 8+ years of experience supporting sterile injectable products, including process validation, technology transfer, and manufacturing operations, particularly in biologics or related modalities. Strong knowledge of aseptic processing, regulatory requirements (FDA, EMA, ICH), and experience with regulatory inspections is essential. Preferred qualifications include advanced degrees, experience with biologics such as monoclonal antibodies, gene therapies, lyophilized products, and managing global manufacturing networks. The role entails leadership in project management, external partner oversight, and strategic initiatives within the injectable and device space.