External Manufacturing Specialist

About the role

The External Manufacturing Specialist oversees contract manufacturing operations—including filling, assembly, and packaging—ensuring timely execution, proper documentation, and compliance with cGMP standards.

Key responsibilities

• Act as Regeneron’s operational contact for contract manufacturers and business partners on day‑to‑day activities.
• Coordinate batch scheduling, material supply, shipment directions, cycle‑time tracking, and documentation for external sites.
• Liaise with Quality Control, Quality Assurance, Supply Chain, Operations/Logistics and external partners to align processes.
• Lead a sub‑team in continuous process improvement, system/equipment implementation, and strategy development.
• Support investigations related to external manufacturing and shipping operations.
• Monitor cGMP compliance at contract sites and review pre‑production master batch records and executed batch records.

Required profile

• BS/BA in a scientific discipline (or equivalent experience).
• Minimum 2 years of experience in cGMP manufacturing operations (clinical or commercial).
• Knowledge of external manufacturing from formulation through final packaging.
• Familiarity with FDA regulations, ICH guidelines, and EU regulations.
• Strong interpersonal and communication skills; ability to work with minimal supervision.
• Willingness to travel up to 25 % domestically and internationally.

Required skills

• Proficiency in Microsoft Excel, PowerPoint, Visio, and Word.
• Understanding of cGMP requirements.
• Knowledge of FDA, ICH, and EU regulatory frameworks.