Packaging & Serialization Specialist – GMP Compliance

Replimune; Framingham (MA); On-site; USD 73,500 - 95,000; Full time

Job summary

Replimune is seeking a Commercial Supply Chain Packaging Associate at our Framingham facility. You will execute packaging and serialization for finished drug products in alignment with cGMP, GDP, and company procedures, collaborating with Commercial Supply Chain and Quality teams.

Responsibilities include equipment setup, line clearance, documentation, and product verification. Preferred candidates have 2+ years in a GMP environment, related degrees, and a keen eye for quality and safety.

Qualifications

• 2+ years experience in a regulated GMP environment.
• Familiarity with cGMP and GDP.
• Experience operating packaging, labeling, or serialization equipment.
• Ability to review and complete batch documentation.

Responsibilities

• Set up, operate, and maintain packaging and serialization equipment per SOPs.
• Perform packaging activities while ensuring cGMP and GDP compliance.
• Complete batch records and related documentation legibly and contemporaneously.
• Verify equipment setup against approved batch documentation.
• Support serialization, printing, aggregation, and tracking of products.
• Conduct in-process quality checks and visual inspections of cartons and vials.
• Escalate issues promptly to management or Quality.

Skills

Attention to detail

Quality compliance

Team collaboration

Education

Associate's degree / Bachelor's degree / Biotechnology certificate

High School Diploma with relevant experience

Job description

Replimune is seeking a Commercial Supply Chain Packaging Associate at our Framingham facility. You will execute packaging and serialization for finished drug products in alignment with cGMP, GDP, and company procedures, collaborating with Commercial Supply Chain and Quality teams.

Responsibilities include equipment setup, line clearance, documentation, and product verification. Preferred candidates have 2+ years in a GMP environment, related degrees, and a keen eye for quality and safety.