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Manufacturing Associate - Framingham, MA

Company: Replimune Group, Inc.
Location: Framingham
Posted on: June 6, 2021

Job Description:

Key Responsibilities:

  • 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.

Educational 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 Requirements:

  • 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.

Keywords: Replimune Group, Inc., Framingham , Manufacturing Associate - Framingham, MA, Other , Framingham, Massachusetts

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