External Manufacturing Specialist, Clinical Pack & Label

Discover your role

• 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 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.
• Coordinates/oversees multiple external manufacturing activities at multiple sites, as required.
• Liaises between various departments within Regeneron including Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments, Legal, Regulatory, Strategic Sourcing and contract manufacturers or business partners.
• Leads sub-teams in continuous process improvements, system/equipment implementation and/or strategy development.
• Leads or supports all investigations which concern external manufacturing and associated shipping operations.
• Ensures product integrity and company reputation monitoring of cGMP compliance at external manufacturing contract manufacturers and business partners.
• Performs reviews of pre-production master batch records and executed batch records.
• Authors documents and procedures.
• Supports audit operations, both internal and external.
• Analyzes data for trends and potential issues.

This role requires

• BS/BA in a scientific discipline and experience in cGMP manufacturing operations (clinical and/or commercial external manufacturing), including experience collaborating with CMOs/CROs, or equivalent combination of education and experience.
• Knowledge of external manufacturing from formulation through the final package.
• Knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
• Proficient in Excel, PowerPoint, Visio, Word, Oracle etc. in addition to experience working within shared work environments.
• Strong interpersonal, written and oral communication skills.
• Confidence, high emotional IQ, and strong interpersonal, written and oral communication skills for providing team updates.
• Ability to impart understanding of provided instructions, develop instructions and set and work towards goals with minimal supervision.
• A degree of ingenuity, creativity and resourcefulness in evolving and ambiguous environments.
• Resiliency and flexibility in the face of challenges and adversarial situations.
• Understanding and listening to team members and stakeholders needs while supporting productive team environments toward a common objective.

Level will be determined based on experience: Associate Specialist – 0-2+ years; Specialist - 2+ years; Senior Specialist - 5+ years.