Manager, Formulation Development

Job description

The Manager, Formulation Development is responsible for leading formulation development and process optimization activities for both new and existing pharmaceutical products, ensuring compliance with quality, regulatory, and timeline requirements. The role involves managing and mentoring a team of formulation scientists and technicians, setting performance objectives, and driving capability development. The manager oversees pilot-scale, scale-up, and validation batch manufacturing activities, providing technical leadership, troubleshooting support, and root-cause analysis for development challenges. Responsibilities include reviewing and approving formulation protocols, batch records, and technical documentation while ensuring adherence to GMP, internal SOPs, and applicable regulatory standards. The role acts as the key interface between formulation development and cross-functional teams including QA, QC, Regulatory Affairs, Production, Engineering, Supply Chain, and Project Management. Additionally, the position drives continuous improvement initiatives and supports successful technology transfer from development to manufacturing, ensuring efficient and compliant product commercialization.