Director of Product Development

Director of Product Development About the Company A globally recognized leader in the biopharmaceutical industry. Industry Pharmaceuticals Type Privately Held About the Role The Company is looking for a Director of Product Development to spearhead all aspects of Chemistry, Manufacturing, and Controls (CMC) product development, from lead optimization through to late-stage clinical development and commercialization. This is an exceptional opportunity for an experienced professional to lead the development of efficient and scalable manufacturing processes, manage technology transfers, and oversee the supply chain for clinical supplies. The ideal candidate must possess a PhD in a relevant scientific field and have a minimum of 15 years of industrial experience with a robust background in CMC, focusing specifically on injectable products. The Director of Product Development will prepare and review all CMC regulatory filings and should have a comprehensive understanding of process and formulation development, analytical science, regulatory requirements, and quality standards. Key responsibilities include: Leading CMC teams and driving project goals. Representing pharmaceutical development in multidisciplinary project teams. Ensuring meticulous planning and execution of product development initiatives. Collaborating effectively with global teams and managing activities with Contract Development and Manufacturing Organizations (CDMOs). The successful candidate will possess strong leadership, communication, and collaboration skills, with the capacity to influence cross-functionally and instigate improvements. A solid understanding of ICH, FDA, EMEA, and USP guidelines is essential, as is experience with regulatory submissions and interactions, particularly with INDs, IMPDs, and NDAs. Travel Percent Less than 10% Functions Product Management