External Manufacturing Project Specialist, Serialization

Regeneron seeks a Project Specialist for its External Manufacturing Serialization team to drive global product launches, manage quality events, and ensure regulatory compliance across serialization and track-and-trace systems. The role coordinates with internal teams and external manufacturing partners to deliver end-to-end serialization readiness.

Responsibilities

• Ensure serialization readiness for new and transferred products across global markets
• Coordinate labeling documents, GTINs, aggregation strategies, and master data with CMOs and 3PLs
• Operate and troubleshoot track-and-trace platforms, managing user access and exception handling
• Support validation activities, CSV testing, and evidence collection for serialization systems
• Serve as liaison with external manufacturing partners to resolve serialization issues and maintain operations

Requirements

• Bachelor's degree in Engineering, Supply Chain, or Life Sciences
• 2+ years of pharma/biotech serialization, packaging, and labeling experience
• Hands-on experience with track-and-trace systems such as Tracelink
• Demonstrated project management skills and technical competency
• Knowledge of DSCSA, EU-FMD, and ROW regulatory requirements
• Experience supporting quality investigations and managing deviations, CAPAs, and complaints

Compensation: $62,355–$128,700 base annually