Principal External Manufacturing Specialist (Drug Product)

Regeneron Pharmaceuticals • Valley, AL

4d • $78,700 - $150,600 • Onsite

About The Position

Regeneron is hiring External Manufacturing Specialists at the Senior or Principal level to oversee external contract manufacturing operations for drug products, including filling, assembly, and packaging. The role manages day-to-day operations, supports timely completion of manufacturing activities and associated documentation, and monitors cGMP compliance. It also provides guidance to other specialists and consults with management on contract manufacturing operations and GMP compliance matters.

The position serves as an operational contact for contract manufacturers and business partners, coordinating production activities across sites and facilitating collaboration among internal Regeneron departments and external partners. It supports investigations, batch record reviews, document authoring, audits, process improvements, and data analysis. The role is based in East Greenbush, New York, with a Monday–Friday schedule of 8:00 a.m.–4:30 p.m. and target travel of up to 25% or more as required.

Requirements

• Bachelor’s degree in a scientific discipline, plus at least 8 years of experience in cGMP manufacturing operations for the Principal Specialist level; experience must include clinical and/or commercial external manufacturing and collaboration with CMOs/CROs, or an equivalent combination of education and experience.
• Knowledge of external manufacturing from formulation through final packaging.
• Knowledge of regulatory compliance, including cGMP and FDA regulations, and familiarity with ICH guidelines and EU regulations.
• Proficiency in Excel, PowerPoint, Visio, Word, Oracle, and shared work environments.
• Strong interpersonal, written, and oral communication skills.
• Ability to provide team updates with confidence and emotional intelligence.
• Ability to understand and communicate instructions, develop instructions, and work toward goals with minimal supervision.
• Ingenuity, creativity, and resourcefulness in evolving and ambiguous environments.
• Resilience and flexibility when facing challenges and adversarial situations.
• Ability to listen to team members and stakeholders and support productive teams working toward common objectives.

Responsibilities

• Serve as Regeneron’s operational contact for contract manufacturing and/or business partner sites concerning day-to-day activities.
• Coordinate external manufacturing activities, including batch scheduling, material supply, shipment direction, cycle-time tracking, supporting documentation, and coordination of required reports and technical expertise.
• Coordinate and oversee multiple external manufacturing activities at multiple sites as required.
• Liaise among Regeneron departments, including Quality Control, Quality Assurance, Supply Chain, Operations/Logistics, Legal, Regulatory, and Strategic Sourcing, and external manufacturers or business partners.
• Lead sub-teams in continuous process improvements, system or equipment implementation, and strategy development.
• Lead or support investigations concerning external manufacturing and associated shipping operations.
• Monitor cGMP compliance at external manufacturing sites to ensure product integrity and protect the company’s reputation.
• Review pre-production master batch records and executed batch records.
• Author documents and procedures.
• Support internal and external audit operations.
• Analyze data for trends and potential issues.
• Travel domestically and internationally, with a 25% target or more as required.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, a 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal