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Senior Microbiology Manufacturing Associate

Company: T2 Biosystems
Location: Lexington
Posted on: June 12, 2021

Job Description:

Manufacturing

Lexington, MA

  • ID: 578-093
  • Full-Time/Regular

The Senior Microbiology Manufacturing Associate will perform day to day production of reagents at our Hartwell manufacturing facility. This position is responsible for executing manufacturing protocols and providing floor leadership during production shifts. The Senior Microbiology Manufacturing Associate is a key contributor to executing testing, verification and validation protocols. This position will report to the Manager, Operations.

Responsibilities:

  • Follow industry compliance standards (cGMP, FDA, ISO) for the production of external controls and other cGMP products.
  • Execute validation protocols for reagent manufacturing processes.
  • Identify potential process improvements for reagent manufacturing processes.
  • Aid in execution of technology transfer plans for new products transitioning from Product Development to Manufacturing.
  • Aid in troubleshooting technical issues.
  • Support implementation of new manufacturing equipment and processes including execution of process capability studies.
  • Assist in executing the IQ, OQ and PQ of equipment.
  • Support/manage sustaining activities and drive cost reduction.
  • Daily manufacturing activities to meet organizational deliverables

Skills and Experience:

  • BS degree with 3-7 years of industry experience within manufacturing/production environment, preferably in a small company/start-up setting.
  • 2-5 years of Microbiology experience.
  • Strong working knowledge of cGMP practices a must.
  • Strong aseptic technique.
  • Excellent organizational, recordkeeping and communication (verbal and written) skills.
  • Strong work ethic to generate high quality work under tight deadlines.
  • Collaborative and proactive approach a must.
  • Self-starter and able to work in a fast-paced environment within a matrix organization.
  • A desire to get a product to market.

Keywords: T2 Biosystems, Boston , Senior Microbiology Manufacturing Associate, Other , Lexington, Massachusetts

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