Manager, Commercial Packaging and Serialization

Replimune•Framingham, MA

8d•$121,000 - $157,500•Onsite

About The Position

The Manager, Commercial Packaging & Serialization is responsible for the end-to-end execution of commercial packaging and serialization operations performed at Replimune’s Framingham site, ensuring compliant, reliable, and efficient product flow from packaging through release and shipment to the 3PL. This role provides direct leadership of the packaging and serialization team, overseeing batch execution, serialization activities, and shipment readiness in accordance with GMP and GDP requirements. The position serves as the operational owner of packaging and serialization processes, ensuring inspection readiness, data integrity, and alignment with supply plans. The role requires strong hands-on experience with packaging line serialization equipment (e.g., Antares), serialization data platforms (e.g., TraceLink), and ERP systems (Oracle) to support effective execution, troubleshooting, and cross-functional coordination.

Requirements

Bachelors degree in Supply Chain, Operations Management, Life Sciences or related field required; advanced degree preferred.
5+ years of experience in pharmaceutical or biotech manufacturing, packaging, or supply chain operations
Direct experience with commercial packaging and serialization operations
Hands-on experience with Antares (or equivalent packaging line serialization systems) and TraceLink (or equivalent serialization platforms)
Working knowledge of Oracle ERP within a regulated supply chain environment
Strong experience working in GMP and GDP-regulated environments
Proven experience with batch record execution/review and SOP management
Demonstrated people leadership experience in frontline operations
Strong problem-solving capability with the ability to troubleshoot across equipment, systems, and processes
Excellent attention to detail and commitment to compliance and documentation accuracy
Experience supporting product launches in a commercial-stage organization

Nice To Haves

advanced degree preferred

Responsibilities

Lead, coach, and develop the commercial packaging and serialization team, driving accountability and high performance
Establish daily/weekly priorities to ensure execution of commercial packaging schedules and shipment timelines
Provide hands-on operational leadership, including issue escalation, troubleshooting, and decision-making
Build team capability in GMP/GDP execution, documentation practices, and serialization operations
Oversee execution of Replimune’s commercial packaging activities, ensuring alignment with production plans and inventory targets
Ensure packaging operations are performed in accordance with approved batch records, SOPs, and quality requirements
Monitor packaging performance (e.g., throughput, right-first-time, deviations) and drive continuous improvement
Manage execution of serialization processes on packaging lines using Antares serialization equipment, including commissioning, aggregation, and reconciliation
Ensure accurate and timely transfer of serialization data to enterprise systems and external stakeholders through TraceLink
Monitor serialization performance and proactively resolve issues impacting line operations or data integrity
Support investigation and resolution of serialization-related deviations, including data discrepancies and EPCIS exceptions
Support operational activities required to prepare and transfer finished drug product from packaging through shipment to the 3PL
Ensure all batch records, serialization data, and shipping documentation are complete and accurate prior to transfer
Coordinate with Warehouse and Supply Chain teams to ensure on-time shipment execution
Ensure strict adherence to GDP and GMP requirements across packaging and shipment processes
Oversee execution and review of batch records, serialization documentation, and SOPs
Ensure documentation accuracy, completeness, and audit readiness
Partner with Quality to manage deviations, CAPAs, change controls, and inspections
Maintain continuous inspection readiness across packaging and serialization operations
Provide operational oversight of packaging line equipment and serialization systems, including Antares interfaces and integration points
Work cross-functionally with IT to ensure effective utilization of TraceLink and Oracle ERP for transaction visibility and data accuracy
Support issue resolution across system interfaces (Antares → TraceLink → Oracle)
Partner with Engineering and Validation to ensure systems remain qualified
Own packaging and serialization-related processes, including SOPs and standard work
Identify and implement improvements to enhance efficiency, reduce deviations, and improve data integrity
Drive disciplined execution, visual management, and operational excellence within team
Collaborate closely with Supply Chain Planning, Warehouse, Quality, Manufacturing, IT, and external vendors as required
Support product launches, artwork changes, and lifecycle management activities
Ensure packaging and serialization requirements are fully integrated into supply chain execution plans
Other duties as assigned.