Head of Drug Product Development

Head of Drug Product DevelopmentAbout the CompanyReputable biotechnology (BioTech) company developing innovative treatmentsIndustryBiotechnologyTypePrivately HeldAbout the RoleThe Company is seeking a Head of Drug Product Development with a strong background in Chemistry, Manufacturing, and Controls (CMC) to lead the full spectrum of CMC drug product development. This includes the design and optimization of manufacturing processes, technology transfer, and the management of the supply chain for clinical and commercial supplies. The successful candidate will be responsible for all CMC regulatory filings and must have a proven track record in leading CMC/formulation teams, particularly in the development of injectable products. Experience with drug-device combination products, including fill-finish processes, and a comprehensive understanding of CMC, from early-stage development to commercialization, are essential. Applicants for the Head of Drug Product Development position at the company should hold a PhD in a relevant scientific field and have at least 15 years' industrial experience, with a focus on injectable drug products. The role requires a leader with a strong technical background in CMC, including formulation and manufacturing process development, and a deep understanding of regulatory and quality aspects. The ideal candidate will have a history of successful collaboration with cross-functional teams, both internally and with external partners, and be adept at managing global CDMO relationships. Key qualifications include experience in all phases of product development, from IND to commercialization, and a solid grasp of ICH, FDA, EMEA, and USP guidelines. The Head of Drug Product Development will also be responsible for setting and managing the team budget, ensuring robust planning and execution of development efforts, and proactively identifying and mitigating risks to advance product development.Travel PercentLess than 10%FunctionsProduct ManagementEngineering