Manager, Production (Formulation)

Manager, Production (Formulation) oversees aseptic filling lines and the overall management and direction of production personnel and processes including formulation, component preparation, aseptic filling, capping and lyophilization. Responsibilities include scheduling, quality control, production operations, QA, engineering, maintenance, equipment validation, investigations of non-conformities, laboratory testing contacts, and product release; establish goals for production aspects; ensure FDA compliance and SOP adherence; coach and develop the team to achieve high-quality injectable pharmaceutical products; develop KPIs and monitor production results to improve quality, reduce deviations, optimize labor utilization, and yield; contribute to quality initiatives and document production results; interact with validations management and Technology Center.