Downstream Manufacturing Consultant

5 days ago


Dublin, Dublin City, Ireland PE Global Full time

Career Opportunity:

As a Technical Services Specialist, you will play a critical role in ensuring the smooth operation of our biopharmaceutical manufacturing facility. Your primary responsibility will be to provide process expertise to support technology transfer, process validation, and routine commercial manufacturing for Downstream manufacturing.

Your Key Responsibilities:

  • You will be responsible for providing support for new/existing drug substance (DS) manufacturing processes at the Dublin facility, working in close collaboration with various departments including Process Development, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory, and others.
  • Accountable for timely completion of commercial sustaining and technical transfer related milestones, emphasizing new product introduction, Process Validation (PPQ), Continued Process Verification (CPV), Risk Assessment (using QRM tools), and supporting technical and manufacturing deviations.


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