ExternalManufacturingSpecialist

Within this role the External Manufacturing Specialist oversees all aspects of 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. **A typical day might include, but is not limited to, the following:** * Serving as a Regeneron operational contact for contract manufacturing and/or business partner sites concerning day-to-day activities * Coordinating 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 expertise * Liaising between various departments within Regeneron including, but not limited to Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners * Leading a sub-team in continuous process improvements, system/equipment implementation and/or strategy development * Supporting all investigations which concern external manufacturing and associated shipping operations * Ensuring product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers and business partners * Performing reviews of pre-production master batch records and executed batch records **This role may be for you if you:** * Knowledge of external manufacturing from formulation through the final package * Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations * Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments * Strong interp