Commercial Supply Chain Prod Pkg Associate I

Replimune•Framingham, MA

4d•Onsite

About The Position

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 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.

Requirements

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.

Nice To Haves

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.

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.