Manufacturing Associate II - 2ND SHIFT
$87,000–$113,000 year
On-siteWoburn, Massachusetts, United States or Woburn, Ontario, Canada
Job Summary
Execute cGMP manufacturing operations to support Replimune product production at the Framingham facility. Author standard operating procedures, batch records, and deviations while maintaining aseptic gowning capabilities. Perform equipment cleaning, stocking, and assembly, including autoclaving components and preparing buffers within approved processes. Conduct visual inspections of final product vials and operate single-use technology for viral production and filtration steps. Ensure training requirements are current and accurately complete production documentation consistent with safety policies and quality systems. Assist with validation commissioning and routine maintenance of production equipment. This 2nd shift role operates Monday through Thursday with a 10-hour schedule and typically includes a 4-day on-site expectation.
Required Qualifications
- Bachelor's degree and 1 to 3 years of related work experience in cGMP biopharma manufacturing
- Associate's degree or High School Diploma and 3 to 6 years of related work experience in cGMP biopharma manufacturing
- Minimum of 1 year working in manufacturing positions in a cGMP environment
- Experience working in one or more functional areas (Cell Culture, Purification of Drug Substance, or aseptic filling of product)
- Experience with single-use manufacturing technologies
- Must be experienced with Microsoft Word and Excel
- Must be available for weekend/holiday work depending on production schedule needs
Desired Qualifications
- Strong organizational skills and attention to detail
- Excellent written and oral communication skills and strong team player
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