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Manufacturing Technician II
Ref No.: 15-03822
Location: Framingham, Massachusetts
Job Responsibilities/Department Description:
Seeking a full-time Senior Manufacturing Technician (40hr/week) able to perform mammalian cell culture manufacturing processes in a pilot facility in a regulated cGMP environment. This includes thawing and expanding cultures in shake flasks and small-scale disposable bioreactors; preparing, inoculating and sampling pilot scale bioreactors; as well as preventative maintenance and basic troubleshooting.

The candidate should also have a familiarity with writing SOPs and batch records and coordinating activities with related groups (Quality, Validation, Metrology, and Facilities). 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. Weekend work is required on a rotating basis.

3-5 years of experience in cGMP cell culture environment and AS degree in a related discipline. High school diploma with the completion of a biotechnology certificate program and 6-8 years relevant experience would be considered. This position also requires physical demands of lifting up to 50 pounds and may involve work with hazardous materials. Occasional weekend work required.

Preferred Qualifications:
Three 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. Candidates with large or small scale bioreactor production experience highly preferred. Ideal candidates will have experience working with automated control systems (Delta V or equivalent).