Sr. Associate, Serialization and Packaging

Replimune Group; Framingham (MA); On-site; USD 103,500 - 133,500; Full time

Job summary

Replimune is seeking a Senior Associate, Serialization & Packaging to join its Framingham, MA facility. You will support commercial packaging and serialization, ensuring quality and regulatory compliance while coordinating with the Packaging team.

The role requires hands-on experience with packaging and serialization systems, including Antares equipment and TraceLink platforms, and involves documentation, training, and continuous improvement in a fast-paced biotechnolgy setting.

Qualifications

• Experience with DSCSA compliance and serialization regulations.
• Knowledge of commercial packaging and serialization processes.
• Ability to train and mentor manufacturing staff.
• Experience with in-house packaging and serialization environments.
• Familiarity with Antares equipment and TraceLink platforms.

Responsibilities

• Support the execution of commercial packaging and serialization activities.
• Operate packaging lines, perform line clearances, troubleshooting, and shutdowns.
• Serve as SME for serialization processes including commissioning and reconciliation.
• Ensure activities align with batch records, SOPs, and GMP requirements.
• Monitor line performance and drive efficiency, quality, and compliance.
• Assist with distribution transfer to 3PL and product transfer activities.

Skills

DSCSA compliance

Serialization knowledge

Training & mentoring

GMP/cGDP knowledge

Problem-solving

Education

Associates Degree / Biotechnology Certificate / Bachelor's Degree in Life Sciences or related

2–4 years GMP environment experience

High School Diploma with pharma experience considered

Tools

Antares

TraceLink

Oracle ERP

Job description

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, TraceLink 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 TraceLink 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 operational personnel.
• Support onboarding and training of new employees on packaging and serialization processes, SOPs, and equipment.
• Develop and maintain training materials, work instructions, and operational best practices.
• Analyze operational metrics and process performance to identify improvement opportunities.
• Lead or participate in continuous improvement initiatives focused on packaging operations, serialization compliance, equipment reliability, and operational efficiency.
• Prepare technical reports, presentations, and operational summaries as required.

Additional Skills/Preferences

• Experience supporting commercial‑stage pharmaceutical products.
• Experience operating within an in‑house packaging and serialization environment.
• Experience with DSCSA compliance and serialization regulations.
• Experience training and mentoring manufacturing or supply chain personnel.
• Experience working with Antares serialization equipment or similar systems.
• Experience using TraceLink or equivalent serialization management platforms.
• Working knowledge of Oracle ERP transactions within operations environment.
• Strong understanding of cGMP, GDP, and Good Documentation Practices.

Educational Requirements

• 2–4 years of experience in a pharmaceutical, biotechnology, medical device, or other regulated GMP environment.
• Associates Degree, Biotechnology Certificate, or Bachelor's Degree in Life Sciences, Engineering, Supply Chain, or related discipline preferred.
• High School Diploma or GED with relevant pharmaceutical or biotechnology industry experience may be considered.

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 $103,500 - $133,500. 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.

We are an Equal Opportunity Employer.