Summary of job description:

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.

Key responsibilities:

Team Leadership & Execution
• 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

Packaging 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

Serialization Operations
• 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

Shipment to 3PL
• 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

GDP, Compliance & Documentation
• 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

Packaging Line & Systems Oversight
• 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

Process Ownership & Continuous Improvement
• 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

Other responsibilities:
• 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.

Educational requirements:
• Bachelors degree in Supply Chain, Operations Management, Life Sciences or related field required; advanced degree preferred.

Experience and skill requirement:
• 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

Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $121,000 - $157,500. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.