Global Serialization & Product Launch Specialist

Regeneron Pharmaceuticals; Valley (AL); On-site; USD 62,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, East Greenbush, NY, is seeking a Project Specialist to join External Manufacturing Serialization. The role drives compliant global product launches, handles quality events, coordinates daily system operations, and leads validation activities across global markets.

You will collaborate with CMOs, 3PLs, EMVOs to ensure end-to-end serialization readiness, DSCSA/EU-FMD/ROW requirements, and master data alignment.

Qualifications

• Hands-on experience with track-and-trace systems (Tracelink) and partner connectivity.
• Experience supporting investigations and quality events (deviations, EOEs, CCs, CAPAs).
• Strong knowledge of DSCSA, EU-FMD, and ROW requirements.
• Experience leading end-to-end serialization implementations and product launches.

Responsibilities

• Ensure serialization readiness for new and transferred products.
• Coordinate labeling documents, GTINs/SSCCs, aggregation strategies, and master data alignment with CMOs/3PLs.
• Complete readiness checks, input-output qualification runs, and planning with Project Managers.
• Support investigations and documentation for validations, deviations, nonconformances, complaints, EOEs, CCs, and CAPAs.
• Maintain audit-ready records and ensure timely closure in accordance with internal QMS and regulatory standards.
• Implement corrective actions, risk assessments, and mitigation plans.
• Operate and coordinate track-and-trace platforms (e.g., Tracelink): user access, master data, partner connections, EPCIS/EDI message monitoring, and exception handling.
• Troubleshoot data flow issues (commissioning, aggregation, decommissioning) to minimize supply disruptions.
• Plan and implement CSV activities (IQ/OQ/PQ), test scripts, and evidence collection for serialization systems and integrations.
• Support technical transfers by aligning serialization requirements, artwork changes, and site configurations.
• Own change controls and configuration baselines across systems and partners.
• Serve as liaison with CMOs, 3PLs, and EMVOs to resolve serialization issues and maintain required operations.
• Communicate timelines, risks, and results; drive cross-functional alignment with Supply Chain Project Managers.
• Apply PM techniques to scope, schedule, and deliver well-defined EM sub-projects.
• Track progress and report status to ensure timely execution.

Skills

Project management

DSCSA knowledge

Track-and-trace systems

Quality investigations

Cross-functional collaboration

Education

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

Tools

Tracelink

Job description

Regeneron Pharmaceuticals, East Greenbush, NY, is seeking a Project Specialist to join External Manufacturing Serialization. The role drives compliant global product launches, handles quality events, coordinates daily system operations, and leads validation activities across global markets.

You will collaborate with CMOs, 3PLs, EMVOs to ensure end-to-end serialization readiness, DSCSA/EU-FMD/ROW requirements, and master data alignment.