Sr. Associate, Serialization and Packaging

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.
 The Senior Associate, Serialization & Packaging is responsible for supporting the execution, coordination, and continuous improvement of commercial packaging and serialization operations at Replimune's Framingham facility. This role serves as a technical resource and subject matter expert for packaging line operations, serialization processes, and associated systems, including Antares serialization equipment, Trace Link serialization platforms, and Oracle transactions supporting commercial distribution.
 Working closely with the Manager, Commercial Packaging & Serialization and Packaging team, this position supports daily packaging operations, batch execution, serialization activities, documentation review, training, troubleshooting, and operational readiness. The Senior Associate plays a critical role in ensuring products are packaged, serialized, documented, and transferred for distribution in compliance with cGMP, GDP, company procedures, and regulatory requirements.
 The ideal candidate combines strong technical knowledge of packaging and serialization operations with hands-on execution experience in a commercial pharmaceutical or biotechnology environment.

Key Responsibilities:

Packaging & Serialization Operations
 
· Support the execution of commercial packaging, labeling, and serialization activities conducted at Replimune's Framingham facility.
 
· Perform setup, operation, line clearance, troubleshooting, and shutdown of packaging and serialization equipment.
 
· Serve as the primary operational resource for serialization processes including commissioning, aggregation, reconciliation, and exception management.
 
· Ensure packaging and serialization activities are executed in accordance with approved batch records, SOPs, and GMP requirements.
 
· Monitor packaging line performance and identify opportunities to improve efficiency, throughput, and compliance.
 
· Support product packaging activities through final shipment preparation and transfer to the 3PL.
 Serialization Systems Support
 
· Serve as the site subject matter expert for serialization operations and associated business processes.
 
· Support operation and troubleshooting of Antares serialization equipment
 
· Monitor and support Trace Link transaction processing, EPCIS data exchange activities, and serialization data integrity.
 
· Execute and review Oracle transactions supporting packaging, inventory movements, and shipment activities.
 
· Support testing, implementation, validation, and deployment of serialization system updates and enhancements.
 
· Investigate and resolve serialization discrepancies, system exceptions, and operational issues.
 Documentation, Compliance & Quality
 
· Complete and review batch records, forms, logbooks, and serialization documentation in accordance with Good Documentation Practices (GDP).
 
· Ensure all packaging and serialization documentation is accurate, complete, and inspection-ready.
 
· Support deviation investigations, CAPAs, change controls, and quality events related to packaging and serialization operations.
 
· Maintain compliance with cGMP, GDP, safety requirements, and internal procedures.
 
· Assist with internal audits, regulatory inspections, and inspection readiness activities.
 Technical Leadership & Continuous Improvement
 
· Provide day-to-day guidance and technical support to Packaging Associates and other…