External Manufacturing Project Specialist, Serialization

Team:
Industrial Operations & Product Supply

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill a Project Specialist to join our External Manufacturing Serialization team. This role drives compliant global product launches, handle quality events, coordinate daily system operations, and lead validation activities across global markets. This role collaborates with internal teams and external partners (CMOs, 3PLs, EMVOs) to ensure end-to-end serialization and track-and-trace readiness.

When & where:

Discover your role:

• Ensure serialization readiness for new and transferred products, including market-specific DSCSA, EU-FMD, and ROW requirements.
• Coordinate supporting documents and attributes for labeling, 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.

This role requires:

• BS/BA in Engineering, Supply Chain, or Life Sciences and the following amount of related experience in pharma/biotech serialization, packaging, and labeling for each level:
  • Associate Specialist – 0-2 years
  • Specialist – 2+ years
  • Sr Specialist – 5+ years
  • Level will be determined based on experience
• Hands-on experience with track-and-trace systems (Tracelink) and partner connectivity.
• Proven support for investigations and quality events (deviations, EOEs, CCs, CAPAs).
• Experience leading end-to-end serialization implementations and product launches, strong knowledge of DSCSA, EU-FMD, and ROW requirements, familiarity with global standards and emerging regulations preferred.

We disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

For additional information about Regeneron benefits…