2nd Shift Manufacturing Associate – cGMP Biopharma

Replimune Group; Framingham (MA); On-site; USD 87,000 - 113,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k Match

Flexible PTO

Year-end shutdown

Job summary

Replimune Group is hiring a Manufacturing Associate I/II for our Framingham, MA facility to execute cGMP manufacturing operations and support cross-department collaboration. The role includes SOP generation/revision and ensuring manufacturing readiness.

This is a 2nd shift, 4-day Mon–Thu, 10-hour schedule with on-site work. Education ranges from bachelor’s with 1–3 years to associate/HS with 3–6 years in cGMP biopharma. Strong focus on quality, safety, and documentation.

Qualifications

• Bachelor’s degree and 1–3 years in cGMP biopharma manufacturing.
• Associate’s degree or HS diploma with 3–6 years in cGMP manufacturing.
• 1 year minimum in manufacturing positions in a cGMP environment.
• Experience in Cell Culture, Purification, or aseptic filling.
• Proficient in Word and Excel.
• Strong organizational skills and attention to detail.
• Excellent written and oral communication; team player.

Responsibilities

• Author SOPs, batch records and deviations.
• Maintain ability to aseptically gown and/or sterile gown as needed.
• Perform stocking and inventory of manufacturing supplies.
• Perform cleaning of process equipment and manufacturing suites.
• Ensure training requirements are up to date in operations performed.
• Assemble, clean and autoclave process components and equipment.
• Prepare buffers and solutions following approved processes.
• Perform aseptic operations within biosafety cabinets and clean room environment.
• Assist with setup and operation of single-use technology production equipment for viral production, tangential flow filtration, chromatography, filtration and aseptic filling steps.
• Become qualified and maintain qualification to perform visual inspection of final product vials.
• Follow procedures and operate production equipment as trained.
• Perform tasks in accordance with safety, quality systems, and cGMP requirements with proper documentation.
• Assist with review of completed manufacturing documentation.
• Support validation commissioning efforts for manufacturing equipment.
• Assist with routine maintenance of production equipment.
• Some weekend/holiday work may be required.

Skills

Organizational skills

Attention to detail

Communication skills

Team player

Microsoft Word

Excel

Single-use manufacturing

Cell Culture

Purification of Drug Substance

Aseptic filling

cGMP experience

Education

Bachelor’s degree with cGMP biopharma experience

Associate’s degree or HS diploma with 3–6 years experience

Tools

Microsoft Word

Excel

Job description

Replimune Group is hiring a Manufacturing Associate I/II for our Framingham, MA facility to execute cGMP manufacturing operations and support cross-department collaboration. The role includes SOP generation/revision and ensuring manufacturing readiness.

This is a 2nd shift, 4-day Mon–Thu, 10-hour schedule with on-site work. Education ranges from bachelor’s with 1–3 years to associate/HS with 3–6 years in cGMP biopharma. Strong focus on quality, safety, and documentation.