Commercial Supply Chain Prod Pkg Associate II

Replimune; Framingham (MA); On-site; USD 74,000 - 95,000; Full time

Job summary

Replimune’s Framingham facility seeks a Commercial Supply Chain Packaging Associate to execute packaging and serialization for finished drug products under cGMP and GDP. The role emphasizes accurate documentation, adherence to procedures, and cross-functional collaboration with Quality teams.

The ideal candidate has 2+ years in regulated GMP environments, and relevant technical education. Base pay ranges from $73,500 to $95,000 with comprehensive benefits and incentives.

Qualifications

• 2+ years of experience in a pharmaceutical, biotechnology, medical device, or other regulated GMP environment.
• Experience operating pharmaceutical manufacturing, packaging, labeling, or serialization equipment.
• Familiarity with cGMP and 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 accuracy and attention to detail.

Responsibilities

• Set up, operate, line clear, shutdown, and clean packaging and serialization equipment per SOPs and batch records.
• Execute packaging activities while maintaining cGMP, GDP, and safety requirements.
• Complete production documentation accurately and contemporaneously per Replimune procedures.
• Verify equipment setup and packaging configurations against approved batch documentation.
• Support serialization operations to ensure accurate printing, aggregation and tracking.
• Perform in-process quality checks and visual inspection of cartons and components.
• Conduct visual inspection of drug product vials as required.
• Escalate equipment issues, deviations, defects, and quality concerns to management/Quality.
• Ensure products are packaged, labeled, and serialized per specifications.
• Move materials and finished product to designated storage locations.
• Maintain supplies of packaging materials and notify supervision for replenishment.
• Support routine cleaning, organization, and maintenance of GMP areas.
• Maintain clean, safe, and organized workstations and production areas.
• Handle materials requiring ultra-low temperature storage with proper PPE.
• Follow all safety policies and PPE requirements.
• Demonstrate reliability, punctuality, and adherence to schedules.
• Collaborate with team members and cross-functional partners to meet objectives.
• Participate in continuous improvement activities to enhance efficiency, quality and compliance.

Skills

GMP environment experience

Packaging operations

Serialization processes

Batch documentation review

Attention to detail

Cross-functional collaboration

Education

Associates degree

Bachelor's degree

Biotechnology certificate

High School Diploma / GED with relevant 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:

· 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 $73,500 - $95,000. 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.

Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.

At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.

We are an Equal Opportunity Employer.