Quality , Science, Pharmaceutical & Food

Process Sciences Specialist – Cell Culture

  • Contract
  • Remote
  • Dublin North
  • 41831440

PE Global is currently recruiting for a Process Sciences Specialist for a client site in Dublin –

 

Reporting through the site manufacturing and technology head and based at the Biotech Dublin site, the Specialist Process Sciences responsibilities include, but are not limited to the following:

 

  • Supporting and executing experimental design, data analysis and interpretation to resolve complex cell culture deviations.
  • Supporting process improvement and troubleshooting with end-to-end product focus.
  • Provide technical support investigations, new process introduction or change implementation in commercial manufacturing operations.
  • Authoring and reviewing development operating procedures and technical reports.
  • Supporting global regulatory submissions as needed.
  • Applying LeanSixSigma tools in the Process Sciences group by:
    • Securing continuity of an appropriate LSS/CEM level of knowledge.
    • Facilitating problem solving & risk assessment (FMEA) projects/meeting.
    • Making problems visible and strive for continuous improvement.

 

 

What skills you will need:

  • A master’s degree (or higher) in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering.
  • 0-3 years’ experience in the Biopharmaceutical industry (preferably practical experience of cell culture processing).
  • Experience in drug substance process development, process characterisation studies, mammalian cell technology, biochemistry, cell biology, fluid mechanics and process modelling.
  • Experience in executing experimental programs in the laboratory.
  • Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
  • Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
  • Knowledge of and experience in applying Six Sigma and Lean methodologies
  • Desirable evidence of Continuous Professional Development

 

 

Interested candidates should submit an updated CV, marked for the attention of Audrey

audrey.mccarthy@peglobal.net  or  00353 21 4297900

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