Manufacturing Associate - Framingham, MA
Company: Replimune Group, Inc.
Posted on: June 6, 2021
- Author SOPs, batch records, deviations and change
- Maintain the ability to aseptically gown and/or sterile gown as
- Perform stocking and inventory of manufacturing supplies.
- Perform cleaning of process equipment and manufacturing
- Ensure training requirements are kept up to date in operations
- Assemble, clean and autoclave process components and
- Prepare buffers and solutions following approved
- Perform aseptic operations within Biosafety cabinets and clean
- Assist with set up and operation of single use technology
production equipment for viral production, tangential flow
filtration, chromatography, filtration and aseptic filling process
- 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
- Support validation commissioning efforts for manufacturing
- Assist with routine maintenance of production equipment.
- May potentially work some weekends and holidays depending on
- 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
- Experience working in two or more functional areas (Cell
Culture, Purification of Drug Substance, or aseptic filling of
- Experience with single-use manufacturing technologies.
- Demonstrated ability to work in cross-functional teams across
- Strong organizational skills and attention to detail.
- Excellent written and oral communication skills and strong team
- 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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