Manufacturing Associate II
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location: Framingham, Massachusetts
job type: Contract
salary: $13.07 - 15.38 per hour
work hours: 7 to 3
education: No Degree Required
The Clinical Trial Manufacturing team has a full-time opportunity for an individual to perform mammalian cell culture manufacturing processes in a pilot facility in a regulated cGMP environment. Reporting into the Manufacturing Manager, this group is part of the Biologics Development Drug Substance Manufacturing organization based in Framingham, Massachusetts This role requires weekend work on a rotating basis.
- Perform thawing and expansion of cultures in shake flasks and small-scale disposable bioreactors
- Preparation, inoculation and sampling of pilot scale bioreactors
- Perform Preventative Maintenance (PMs) and basic troubleshooting.
- Participate in clinical manufacturing under cGMP regulations which includes sampling, analyzing, documenting, witnessing production events, and equipment reprocessing.
- Operate complex systems and equipment using batch records and SOPs in accordance with current GMPs and safety guidelines under limited supervision.
- Associates degree or High school diploma/GED or Biotechnology certificate with a minimum of 3 years' experience in cGMP cell culture environment
- Large-scale or small-scale bioreactor production experience.
- Candidates should demonstrate good technical writing skills, good troubleshooting skills, strong attention-to-detail and developed communication skills.
- Ability to lift up to 30 pounds .
- Must be available for weekend and holiday work, as required.
- Experience with Mammalian cell culture cGMP manufacturing
- Experience with bacteria or yeast culture using similar equipment and SOP's
- Experience with the use of cell culture analyzers
- Experience working with automated control systems (Delta V or equivalent) and single-use technology .
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.