Confidential is hiring: Vice President, Manufacturing in Exton

Vice President, Manufacturing

About the Company

Pioneering biotechnology (BioTech) company

Industry
Biotechnology

Type
Privately Held

About the Role

The Company is seeking a VP 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 in manufacturing strategy implementation, collaboration with clinical operations and quality assurance for regulatory compliance, and leading manufacturing scale-up for flagship products. The role also encompasses departmental P&L responsibility, development of risk mitigation strategies, and direct oversight of in-house manufacturing facility development. Applicants for the VP 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 and facilities organization, champion a culture of regulatory compliance, and proactively identify and resolve operational challenges.

Travel Percent
Less than 10%

Functions

• Operations