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:
1. Serving as a Regeneron operational contact for contract manufacturing and/or business partner sites concerning day-to-day activities.
2. 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.
3. 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.
4. Leading a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
5. Supporting all investigations which concern external manufacturing and associated shipping operations.
6. Ensuring product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers and business partners.
7. Performing reviews of pre-production master batch records and executed batch records.
8. Traveling up to 25% (domestic and international), as required.
This role might be for you if:
1. You have experience working in complex and matrix environment.
2. Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.
3. Knowledge of external manufacturing from formulation through the final package.
4. You have knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
5. Exhibits confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.
To be considered for this position you must hold a BS/BA in scientific discipline. For Senior Specialist you must have 5 years of related experience in cGMP manufacturing operations (clinical and/or commercial).
#J-18808-Ljbffr