About The Position

In this vital role you will be a part of the Process Development Drug Substance Technology group at FleX Batch Biologics Manufacturing Facility. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network. Why is the Position Open? Supplement additional workload on team.

Requirements

  • Manufacturing support
  • Downstream Tech transfer
  • Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Responsibilities

  • Apply a fundamental understanding of Downstream bioprocessing to support biologics technology transfer, process validation, plant start-up, MFG troubleshooting and investigations
  • Support continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management
  • Ensure safety and compliance of process development activities
  • Provide person-in-plant on floor process support as required
  • Provide support for regulatory filing, inspection, and other CMC activities
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