cGMP Biopharma Manufacturing Associate I

Replimune; Framingham (MA); On-site; USD 79,000 - 103,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Flexible time off

Year-end shutdown

Job summary

Replimune is seeking a Manufacturing Associate I/II in Framingham, MA to execute cGMP manufacturing operations for the production of Replimune products. You will collaborate across departments, support SOP generation and documentation, and help ensure manufacturing readiness.

Responsibilities include authoring batch records, maintaining aseptic methods, inventory, equipment cleaning, and qualification maintenance, with potential weekend shifts based on production needs.

Qualifications

• Bachelor's degree and 1–3 years of related work experience in cGMP biopharma manufacturing preferred.
• Associate degree or HS diploma and 3–6 years of related work experience in cGMP biopharma manufacturing.
• Minimum 1 year working in manufacturing positions in a cGMP environment.
• Experience in Cell Culture, Purification of Drug Substance, or aseptic filling.
• Experience with single-use manufacturing technologies.
• Strong organizational skills and attention to detail.
• Excellent written and oral communication skills; strong team player; Microsoft Word and Excel proficient.

Responsibilities

• Author SOPs, batch records and deviations.
• Maintain the ability to aseptically gown and/or sterile gown.
• Perform stocking and inventory of manufacturing supplies.
• Perform cleaning of process equipment and manufacturing suites.
• Ensure training requirements are kept up to date in operations.
• 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 in performing processing steps and operating production equipment.
• Perform tasks in safety, quality systems, and cGMP; complete production documentation.
• Assist with the review of completed manufacturing documentation.
• Support validation commissioning efforts for manufacturing equipment.
• Assist with routine maintenance of production equipment.

Skills

cGMP manufacturing

SOP adherence

Documentation

Aseptic processing

Single-use tech

Organizational skills

Communication skills

Education

Bachelor's degree in related field

Associate degree or HS diploma with experience

Tools

Microsoft Word

Microsoft Excel

Job description

Replimune is seeking a Manufacturing Associate I/II in Framingham, MA to execute cGMP manufacturing operations for the production of Replimune products. You will collaborate across departments, support SOP generation and documentation, and help ensure manufacturing readiness.

Responsibilities include authoring batch records, maintaining aseptic methods, inventory, equipment cleaning, and qualification maintenance, with potential weekend shifts based on production needs.