Manager, Commercial Packaging and Serialization

Overview

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

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 & Contin