Global Serialization & External Manufacturing Specialist

Regeneron Pharmaceuticals, Inc.; Town of East Greenbush (NY); On-site; USD 62,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Project Specialist to join our External Manufacturing Serialization team in East Greenbush, NY.

This role drives compliant global product launches, handles quality events, coordinates daily system operations, and leads validation activities across markets. You will collaborate with CMOs, 3PLs, and EMVOs to ensure end-to-end serialization readiness, with a focus on DSCSA, EU-FMD, and ROW requirements, while maintaining robust data integrity and

Qualifications

• Experience with serialization readiness and DSCSA/EU-FMD compliance.
• Experience coordinating with CMOs and 3PLs on labeling, GTINs, and data alignment.
• Hands-on exposure to track-and-trace systems and validation activities.

Responsibilities

• Ensure serialization readiness for new and transferred products across markets.
• Coordinate labeling, GTINs/SSCCs, and master data with CMOs/3PLs.
• Perform readiness checks and planning with Project Managers.
• Support investigations, deviations, CAPAs, and quality events.
• Maintain audit-ready records per QMS and regulatory standards.
• Lead CSV activities (IQ/OQ/PQ) for serialization systems.

Skills

Track-and-trace systems

Project management

Serialization implementations

DSC SA/EU-FMD knowledge

Education

BS/BA in Engineering, Supply Chain, or Life Sciences

Tools

Tracelink

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Project Specialist to join our External Manufacturing Serialization team in East Greenbush, NY.

This role drives compliant global product launches, handles quality events, coordinates daily system operations, and leads validation activities across markets. You will collaborate with CMOs, 3PLs, and EMVOs to ensure end-to-end serialization readiness, with a focus on DSCSA, EU-FMD, and ROW requirements, while maintaining robust data integrity and