Principal External Manufacturing Specialist, Drug Product

Regeneron seeks a Principal or Senior External Manufacturing Specialist to oversee contract manufacturing operations including filling, assembly, and packaging. The role manages day-to-day activities across multiple external sites, ensures cGMP compliance, and coordinates with internal departments and manufacturing partners.

Responsibilities

• Serve as primary Regeneron contact for external manufacturing and business partner sites on operational matters
• Coordinate external manufacturing activities including batch scheduling, material supply, shipment direction, and cycle time monitoring
• Oversee multiple external manufacturing operations at different sites simultaneously
• Lead or support investigations concerning external manufacturing and shipping operations
• Ensure cGMP compliance monitoring at contract manufacturers and review batch records

Requirements

• Bachelor's degree in scientific discipline
• 5+ years (Senior) or 8+ years (Principal) cGMP manufacturing experience with CMOs/CROs
• Knowledge of external manufacturing from formulation through final packaging
• Regulatory compliance expertise including cGMP, FDA, ICH, and EU regulations
• Proficiency in Excel, PowerPoint, Visio, Word, Oracle, and shared work environments
• Strong written and oral communication and interpersonal skills
• Ability to work independently with minimal supervision in ambiguous environments