Manufacturing Process Lead

5 days ago

Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland beBeeDevelopment Full time €90,000 - €120,000
Process Development Leader

You will lead technical delivery of new product introductions and lifecycle management products.

  • Lead new product introductions and lifecycle changes into the vial and syringe plants from a Process Development perspective.
  • Manage tech transfer engineers/scientists supporting vial and syringe transfers to Dun Laoghaire.
  • Be a key contributor to regulatory filings as part of the NPI process.
Required Skills:
  • Bachelor's degree in Science, Engineering or Quality discipline with 5 years' experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience.
  • Knowledge of cGMPs and other worldwide regulatory requirements.
  • Problem solving ability and excellent oral and written communications skills.
Preferred Qualifications:
  • PhD or Masters in Science or Engineering.
  • 5 + years of experience in support of Commercial Protein Drug Product processing in areas like Sterile Processing, Process Characterization, Tech Transfer or Validation.
  • Strong skills in applying engineering and scientific principles to design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes.

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