GMP Packaging & Serialization Associate

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

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.