MSAT Process Expert

Vor 6 Tagen


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 in our Manufacturing Science & Technology team, you'll be part of a pioneering Drug Substance Manufacturing site for Biologics in Lengnau, Switzerland.

Discover Impactful Work:

In this role, you'll lead technology transfer to support Drug Substance manufacturing of biologics during Engineering Runs, GMP/clinical, PPQ and routine commercial runs. You'll provide expertise in upstream drug substance processes, including cell culture expansion, perfusion systems, feeding strategies, continuous centrifugation, process monitoring and control.

A Day in the Life:

  • 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.
  • Supports CMC/regulatory filing documentation.

Keys to Success:

Education:

  • MSc or PhD in engineering, biotechnology, cell biology, molecular biology, biochemistry or related field.

Experience:

  • Experience in Drug Substance GMP manufacturing ( > 4yrs, PhD > 2yrs) including overall knowledge in upstream process area.
  • Experience in technical operation environment ( > 2 yrs).

Knowledge, Skills, Abilities:

  • 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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