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Manufacturing Associate II
Ref No.: 18-06601
Location: Framingham, Massachusetts
Seeking a full-time contractor (40hr/week, Monday – Friday plus rotating weekends) able to perform mammalian cell culture manufacturing processes in a regulated cGMP environment. Under minimal supervision, candidate will perform thawing and expansion of cultures in shake flasks and small-scale disposable bioreactors; preparation, inoculation and sampling of bioreactors; as well as preventative maintenance and basic troubleshooting. Experience with the use of cell culture analyzers is a plus. The candidate will participate in clinical manufacturing under cGMP regulations which include; sampling, analyzing, documenting, witnessing production events, and equipment reprocessing. The successful candidate should have the ability to operate complex systems and equipment using batch records and SOPs in accordance with current GMPs and safety guidelines under limited supervision. Monday through Friday shift with additional, frequent weekend and holiday work required.

Basic Qualifications-
At least 2 years experience in cGMP cell culture environment and AS degree or higher in a related discipline. High school diploma with the completion of a biotechnology certificate program with 4+ years relevant experience would be considered. Past experience must include manufacturing experience with small-scale cell culture and bioreactors in a cGMP regulated environment. This position also requires physical demands of lifting up to 50 pounds and may involve work with hazardous materials.

Preferred Qualifications-
Five plus years of related cGMP cell culture manufacturing experience. Candidates should demonstrate good technical writing skills, good troubleshooting skills, strong attention to detail and developed communication skills. Ideal candidates will have experience working with automated control systems (Delta V or equivalent) and single-use technology.