External Manufacturing Project Specialist, Serialization

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 62,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) in East Greenbush, NY seeks a Project Specialist to drive compliant global product launches within External Manufacturing Serialization. You will coordinate labeling attributes, GS1 identifiers, and master data with CMOs/3PLs, while managing validations and quality events under QMS.

This on-site role requires DSCSA/EU-FMD knowledge and hands-on Tracelink experience. The position involves cross-functional collaboration, change control ownership, and tracking

Qualifications

• BS/BA in Engineering, Supply Chain, or Life Sciences.
• 0–2 years: Associate Specialist; 2+ years: Specialist; 5+ years: Sr Specialist; level based on experience.
• Hands-on experience with track-and-trace systems (Tracelink) and partner connectivity.
• Experience supporting 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.

Responsibilities

• Ensure serialization readiness for new and transferred products, including market-specific DSCSA, EU-FMD, and ROW requirements.
• Coordinate 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 per 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 monitoring, exception handling.
• Troubleshoot data flow issues to minimize supply disruptions.
• Plan and implement CSV activities (IQ/OQ/PQ) 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; drive cross-functional alignment with Supply Chain PMs.
• Apply PM techniques to scope, schedule, and deliver EM sub-projects.
• Track progress and report status to ensure timely execution.

Skills

Track-and-trace systems experience (Tr

Project management

Serialization/DSCSA knowledge

Quality events investigations support

Education

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

Tools

Tracelink platform

Job description

Build 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 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: 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.

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 such accommodation would impose undue hardship. Where necessary, 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.

Salary Range (annually) $62,355.00 - $128,700.00

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 in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. For jobs in Canada: this posting is for an existing position.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.