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LOLonza

Process Expert MSAT(m/w/x)

Visp
VollzeitVor OrtSenior

Transfer, scale-up, and optimization of mammalian/purification manufacturing at a global biopharmaceutical CMO. Five years biopharmaceutical manufacturing or process development experience required; mammalian cell or purification expertise preferred. Contribution to MSAT toolbox development.

Anforderungen

  • PhD (preferred), Master’s or Bachelor degree in biotechnology, chemical engineering or related disciplines
  • Minimum five years industry experience in biopharmaceutical manufacturing or process development
  • Strong preference for expertise in mammalian cell based and/or purification focused operation
  • Understanding of GMP and bioprocess technology
  • Very good communication and interaction skills
  • Fluency in English

Aufgaben

  • Transfer mammalian/purification manufacturing processes.
  • Scale up mammalian/purification manufacturing processes.
  • Supervise mammalian/purification manufacturing processes.
  • Optimize mammalian/purification manufacturing processes.
  • Contribute to developing the MSAT toolbox.
  • Act as a long-term process owner.
  • Lead cross-functional teams for technology transfers.
  • Lead teams for process design and scaling-up.
  • Implement processes at manufacturing scale.
  • Manage the full product lifecycle of assigned projects.
  • Act as interface between process donors and operations.
  • Ensure process scalability.
  • Ensure process manufacturability.
  • Ensure successful technology transfer.
  • Manage information transfer, process risks, and change control.
  • Resolve manufacturing process issues.
  • Ensure regulatory compliance during issue resolution.
  • Perform 24/7 on-call duty.
  • Perform GMP risk analysis for manufacturing processes.
  • Interact with customers during tech transfer and campaigns.
  • Provide daily reports on batch status and performance.
  • Prepare timely process deviations, change requests, campaign reports.
  • Drive continuous improvement of process performance.

Berufserfahrung

  • 5 Jahre

Ausbildung

  • Bachelor-AbschlussODER
  • Master-Abschluss

Sprachen

  • Englischverhandlungssicher
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