The Manufacturing Associate is responsible for executing the cGMP manufacturing operations to support the production of Replimune products at the Framingham, MA, facility. This individual will collaborate with multiple departments to support the manufacturing technology transfer and startup of the production facility and will assist with the generation/revision of Standard Operating Procedures and associated documentation to ensure manufacturing readiness.

This position is based in our Framingham location and typically has a 5 day on-site expectation.

• Author SOPs, batch records, deviations and change controls.
• Maintain the 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 kept up to date in operations being 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 set up and operation of single use technology production equipment for viral production, tangential flow filtration, chromatography, filtration and aseptic filling process steps.
• Become qualified and maintain qualification to perform visual inspection of final product vials.
• Follow verbal and written procedures in performing processing steps and operating production equipment.
• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements and accurately completes appropriate production documentation.
• Assist with the review of completed manufacturing documentation.

Other responsibilities:

• Support validation commissioning efforts for manufacturing equipment.
• Assist with routine maintenance of production equipment.
• May potentially work some weekends and holidays depending on production schedule.

Education requirements:

• Bachelor’s degree and 1 year of related work experience in cGMP biopharma manufacturing preferred; or
• Associates degree or High School Diploma and 3 to 6 years of related work experience in cGMP biopharma manufacturing.

Experience and skill requirement:

• Minimum of 1 year working in positions in cGMP environment.
• Experience working in two or more functional areas (Cell Culture, Purification of Drug Substance, or aseptic filling of Product).
• Experience with single-use manufacturing technologies.
• Demonstrated ability to work in cross-functional teams across the business.
• Strong organizational skills and attention to detail.
• Excellent written and oral communication skills and strong team player.
• Ability to lift objects up to 50 pounds and stand for up to 3 hours at a time is required.
• Must be experienced with Microsoft Word and Excel.

Location:

This position is based in our Framingham location and typically has a 5 day on-site expectation.