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External Manufacturing Specialist

Regeneron · Rensselaer, New York, US

We are currently looking to fill a Specialist position within the Advanced Therapies External Manufacturing team that specializes in synthetic or fermentatio...

Job description

We are currently looking to fill a Specialist position within the Advanced Therapies External Manufacturing team that specializes in synthetic or fermentation-based processes. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. This role oversees all aspects of contract manufacturing organizations and partners including day-to-day operations, ensuring timely completion of associated operations/documentation, and assisting in the monitoring of cGMP compliance. As a Specialist of External Manufacturing (Advanced Therapies), a typical day might include the following: Serving as the operational contact for contract manufacturing and/or partner sites concerning day-to-day activities. Coordination of 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 material, tracking and monitoring of cycle times, providing support for manufacturing activities and enlisting support from others who will provide any required associated reports and t...