Commercial Packaging & Serialization Specialist 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

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.