Commercial Supply Chain Prod Pkg Associate I

Replimune Group; Framingham (MA); On-site; USD 66,500 - 86,000; Full time

Job summary

Replimune Group, Inc. in Framingham, MA, is seeking a Commercial Supply Chain Packaging Associate to execute packaging and serialization for finished drug products in a cGMP environment.

You will ensure quality, compliance, and patient safety while documenting processes and collaborating with Supply Chain and Quality teams. The role focuses on setup, operation, and maintenance of packaging lines, completing batch records, and supporting serialization to enable accurate product tracking.

Qualifications

• 1–2 years in a pharmaceutical/biotech GMP environment.
• Associates degree, Bachelor’s degree, Biotechnology Certificate, or equivalent technical training.
• High School Diploma or GED with relevant pharmaceutical/biotechnology experience may be considered.
• Experience operating pharmaceutical manufacturing, packaging, labeling, or serialization equipment.
• Familiarity with cGMP and GDP.
• Understanding of serialization processes and requirements.
• Experience reviewing and completing batch documentation in a regulated environment.
• Demonstrated ability to perform packaging operations with accuracy and attention to detail.

Responsibilities

• Set up, operate, line clear, shut down, and clean packaging and serialization equipment per SOPs and batch records.
• Perform packaging activities in compliance with cGMP, GDP, and safety requirements.
• Complete all production documentation accurately and contemporaneously.
• Verify equipment setup and packaging configurations against batch docs.
• Support serialization to ensure accurate printing, aggregation, and tracking of product.
• Conduct in‑process quality checks and visual inspection of cartons and components.
• Escalate issues to management or Quality personnel as needed.
• Ensure packaging, labeling, and serialization meet specifications and commercial requirements.
• Move materials and finished product to designated storage.
• Maintain supplies of packaging materials and notify for replenishment.
• Assist in cleaning, organization, and maintenance of GMP areas.
• Maintain clean, safe workstations and production areas.
• Handle materials requiring ultra‑low temperature storage with proper PPE.
• Follow safety policies and procedures.

Skills

Packaging operations

Serialization

cGMP

GDP

Documentation

Quality checks

Team collaboration

Safety procedures

Continuous improvement

Education

Associates degree or equivalent

Bachelor’s degree or equivalent

Biotechnology certificate or equivalent training

High School Diploma/GED with related experience

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.

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 Commercial Supply Chain Packaging Associate is responsible for executing packaging and serialization activities for finished drug product at Replimune's Framingham facility in accordance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and company procedures. This role supports the packaging of commercial products while ensuring the highest standards of quality, compliance, and patient safety. The role requires strict adherence to approved procedures, accurate documentation practices, and effective collaboration across the Commercial Supply Chain and Quality teams.

Key responsibilities

• Perform the setup, operation, line clearance, shutdown, and cleaning of packaging and serialization equipment in accordance with approved SOPs and batch records.

• Execute packaging activities while maintaining compliance with cGMP, GDP, and safety requirements.

• Complete all required production documentation (e.g. batch records, forms, etc.) accurately, legibly, and contemporaneously in accordance with Replimune procedures.

• Verify that equipment setup and packaging configurations match approved batch documentation and operational requirements.

• Support serialization operations to ensure accurate printing, aggregation, and tracking of commercial product.

• Perform in-process quality checks and visual inspection of cartons and finished product components during packaging operations.

• Conduct visual inspection of drug product vials as required.

• Escalate equipment issues, process deviations, product defects, and quality concerns immediately to management or Quality personnel.

• Ensure products are packaged, labeled, and serialized in accordance with approved specifications and commercial requirements.

• Move materials and finished drug product safely to designated storage locations.

• Maintain adequate supplies of packaging materials and notify supervision of replenishment needs.

• Support routine cleaning, organization, and maintenance of GMP manufacturing and packaging areas.

• Maintain clean, safe, and organized workstations and production areas.

• Handle and package materials requiring ultra‑low temperature storage (up to -80 °C) while utilizing appropriate PPE and handling procedures.

• Follow all safety policies, procedures, and PPE requirements.

• Demonstrate reliability, punctuality, and adherence to established work schedules.

• Collaborate effectively with team members and cross‑functional partners to achieve departmental objectives.

• Participate in continuous improvement activities to enhance operational efficiency, quality, and compliance.

Preferred Experience / Education

• 1–2 years of experience in a pharmaceutical, biotechnology, medical device, or other regulated GMP environment.
• Associates degree, Bachelors degree, Biotechnology Certificate, or equivalent technical training.
• High School Diploma or GED with relevant pharmaceutical or biotechnology industry experience may be considered.
• Experience operating pharmaceutical manufacturing, packaging, labeling, or serialization equipment.
• Familiarity with cGMP and Good Documentation Practices (GDP).
• Understanding of pharmaceutical serialization processes and requirements.
• Experience reviewing and completing batch documentation in a regulated environment.
• Demonstrated ability to perform packaging operations with consistency, accuracy, and attention to detail.

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 $66,500 - $86,000. 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.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV‑1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti‑tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus‑mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.