External Manufacturing Project Specialist, Serialization
About The Position
Regeneron is seeking a Project Specialist to join its External Manufacturing Serialization team. The role supports compliant global product launches, quality events, daily serialization-system operations, and validation activities across global markets. It works with internal teams and external partners, including contract manufacturing organizations (CMOs), third-party logistics providers (3PLs), and European Medicines Verification Organisation stakeholders (EMVOs), to ensure end-to-end serialization and track-and-trace readiness. The position covers serialization readiness for new and transferred products; coordination of product, packaging, labeling, and master-data requirements; support of investigations and quality documentation; operation of track-and-trace platforms; validation and computer system validation activities; technical transfers; change control; and cross-functional project coordination. The level (Associate Specialist, Specialist, or Senior Specialist) will be determined based on experience. The role is located in East Greenbush, New York, and the stated schedule is Monday through Friday, 8:00 a.m. to 4:30 p.m.
Requirements
- BS/BA in Engineering, Supply Chain, or Life Sciences.
- Related pharmaceutical or biotechnology experience in serialization, packaging, and labeling: 0–2 years for Associate Specialist, 2+ years for Specialist, or 5+ years for Senior Specialist; level is determined based on experience.
- Hands-on experience with track-and-trace systems such as TraceLink and partner connectivity.
- Experience supporting investigations and quality events, including deviations, EOEs, CCs, and CAPAs.
- Demonstrated project-management skills.
Nice To Haves
- Experience leading end-to-end serialization implementations and product launches.
- Strong knowledge of DSCSA, EU-FMD, and rest-of-world requirements.
- Familiarity with global standards and emerging regulations.
Responsibilities
- Ensure serialization readiness for new and transferred products, including market-specific DSCSA, EU-FMD, and rest-of-world requirements.
- Coordinate supporting documents and attributes for labeling, GTINs/SSCCs, aggregation strategies, and master-data alignment with CMOs and 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, including user access, master data, partner connections, EPCIS/EDI message monitoring, and exception handling.
- Troubleshoot data-flow issues involving commissioning, aggregation, and 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.
- Liaise with CMOs, 3PLs, and EMVOs to resolve serialization issues and maintain required operations.
- Communicate timelines, risks, and results, and drive cross-functional alignment with Supply Chain Project Managers.
- Apply project-management techniques to scope, schedule, and deliver well-defined External Manufacturing sub-projects.
- Track progress and report status to support timely execution.
Benefits
- Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life, and disability), paid time off, and family support benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
