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Manufacturing Associate

Cambridge, Massachusetts 02139

Post Date: 03/29/2018 Job ID: 18507 Industry: Other Area(s)

Here’s What You’ll Do:

 

The successful candidate will aid in the cGMP production of our clients Live Bio-therapeutic Products (LBP). They will also have the opportunity to assist with aspects of supply chain management, coordination of 3rd party vendors, and continuous improvement initiatives. Previous experience with cell banking, cell culture, fermentation, cross-flow filtration, lyophilization, and/or capsule filling is desired.

Core Responsibilities:

  • Manufacturing Master Cell Banks, Drug Substance and Drug Product in a cGMP environment
  • Authoring and revising SOPs and Batch Records
  • Contributing to Manufacturing-related Deviations, CAPAs and Change Controls
  • Ordering, inventorying and preparing raw materials and single-use components for use
  • Operating and maintaining small-scale process equipment
  • Coordinating 3rd party contractors and vendors

Requirements:

  • BS in a Scientific Discipline or Engineering
  • Minimum 3 to 5 years of hands on experience with cGMP manufacturing
  • Direct experience with cell banking, cell culture, fermentation, cross-flow filtration, lyophilization, and/or capsule filling is desired

Jeanne Edwards


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