Principal External Manufacturing Specialist

Job description

We are currently looking to fill a Principal External Manufacturing Specialist. The Principal External Manufacturing Specialist oversees all aspects of external manufacturing contract manufacturing operations (filling, assembly, packaging) including day-to-day operations, ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance. Additionally, the Principal Specialist provides guidance to other specialists as well as consults with management on all contract manufacturing operations and GMP compliance issues. In this role, a typical day might include the following: Serves as a Regeneron operational contact for contract manufacturing and/or business partner sites concerning day-to-day activities. Coordinates external manufacturing activities at contract and/or business partner sites, including but not limited to: scheduling of all batches, supply of materials, providing direction on shipment of bulk or finished product, tracking and monitoring of cycle times, providing supporting documentation for manufacturing activities and enlisting support from others who will provide any required associated reports and technical expertis...