Vice President, Manufacturing
About the Company
Reputable biotechnology (BioTech) company
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is seeking a VP of Manufacturing to lead its GMP production operations, with a focus on driving manufacturing excellence from preclinical to commercial launch. This strategic role involves spearheading clinical manufacturing initiatives and building the foundation for commercial-scale operations in preparation for BLA submission. The successful candidate will be instrumental in establishing manufacturing capabilities and ensuring seamless supply chain execution for innovative cell and gene therapy programs. Key responsibilities include strategic leadership, driving manufacturing strategy implementation, collaborating with clinical operations and quality assurance for regulatory compliance, and leading manufacturing scale-up for flagship products. The role also requires owning departmental P&L, developing risk mitigation strategies, and overseeing in-house manufacturing facility development. Applicants for the VP of Manufacturing position at the company should have an advanced degree in a relevant scientific field, with a Ph.D. strongly preferred. A minimum of 10 years' experience in implementing cell culture systems in cGMP manufacturing environments, and at least 8 years in a Director-level or higher manufacturing operations role, is required. The ideal candidate will have a proven track record in manufacturing and supply chain success, hands-on experience with commercial cell culture systems, and expertise in technology transfer and scale-up of cell culture systems. Experience with complex regulatory submissions, including BLA preparation, and a history of successful FDA or international regulatory agency inspections are also essential. The role demands a leader who can build and lead a world-class manufacturing organization, champion a culture of regulatory compliance, and proactively resolve operational challenges while fostering cross-departmental collaboration.
Travel Percent
Less than 10%
Functions
- Engineering