External Manufacturing Project Specialist, Serialization
Regeneron Pharmaceuticals IncBuild our future together:
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 mark
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ets. 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:
• Location: East Greenbush, New York, United States
• Work schedule: Monday-Friday, 8am-4:30pm
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).
• Demonstrate project management skills.
• 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.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless s