Senior Associate, Serialization and Packaging

Responsibilities

• Support the execution of commercial packaging, labeling, and serialization activities at the 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, and reconciliation
• Monitor and support TraceLink transaction processing and EPCIS data exchange activities
• Execute and review Oracle transactions supporting packaging, inventory movements, and shipment activities
• Complete and review batch records, forms, and logbooks in accordance with Good Documentation Practices (GDP)
• Support deviation investigations, CAPAs, change controls, and quality events
• Provide technical support and guidance to Packaging Associates and assist with onboarding and training

Requirements

• 2–4 years of experience in a pharmaceutical, biotechnology, medical device, or regulated GMP environment
• Associates Degree, Biotechnology Certificate, or Bachelor's Degree in Life Sciences, Engineering, or Supply Chain preferred
• High School Diploma or GED with relevant industry experience may be considered
• Strong understanding of cGMP, GDP, and Good Documentation Practices

Preferred Qualifications

• Experience supporting commercial-stage pharmaceutical products
• Experience with DSCSA compliance and serialization regulations
• Experience with Antares serialization equipment or similar systems
• Experience using TraceLink or equivalent serialization management platforms
• Working knowledge of Oracle ERP transactions within an operations environment

About the Company

Replimune is pioneering the development of a novel portfolio of oncolytic immunotherapies to transform cancer treatment through its proprietary RPx platform.