MSAT Process Expert

vor 2 Monaten


Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Vollzeit

At Thermo Fisher Scientific, we're driven by a passion for exploration and discovery. As a key player on our Manufacturing Science & Technology team, you'll be part of a pioneering team that's shaping the future of biologics manufacturing.

Key Responsibilities:

  • Lead technology transfer to support Drug Substance manufacturing of biologics during Engineering Runs, GMP/clinical, PPQ and routine commercial runs.
  • Provide expertise in upstream drug substance processes (cell culture expansion, perfusion systems, feeding strategies, continuous centrifugation, process monitoring and control) using single-use technology and stainless-steel equipment.
  • Translate process requirements into automated execution systems (MES, PCS) interacting with equipment.
  • Technical leadership and support to manufacturing activities including data trending, deviation investigation, impact assessment, risk mitigation and continuous improvement.
  • Direct interaction with clients through preparation, execution, and follow-up of manufacturing campaigns.
  • Support CMC/regulatory filing documentation.

Requirements:

  • MSc or PhD in engineering, biotechnology, cell biology, molecular biology, biochemistry or related field.
  • Experience in Drug Substance GMP manufacturing ( > 4yrs, PhD > 2yrs) including overall knowledge in upstream process area.
  • Experience in technical operation environment ( > 2 yrs).
  • Proficiency in working with multicultural and cross-disciplinary project teams.
  • Excellent organization, planning, problem solving and critical thinking skills.
  • Excellent writing, communication and presentation skills.
  • Energy and drive (action oriented, drive for results).
  • Language: Fluency in English, German knowledge preferable.

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