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Upstream Manufacturing Expert Lead

vor 2 Wochen


Bern, Bern, Schweiz Recrutis Vollzeit

Recrutis Client Overview: Our client is a leading Worldwide Biotech company based in Bern area, known for its commitment to innovation and excellence in the field of drug substance manufacturing.

Job Responsibilities:

  1. Coordinate technical and laboratory activities in support of technology transfer, continued cGMP manufacturing, and process improvements.
  2. Provide guidance on USP Process Transfer & Sciences SME activities, including GMS lab operations and studies.
  3. Lead cross-functional project teams to facilitate process transfer, validation, and process life cycle activities.
  4. Ensure technical manufacturing support through process monitoring, issue resolution, and participation in operations governance huddles.
  5. Investigate technical process issues, perform root-cause analysis, and define corrective measures and effectiveness checks.

Requirements:

  • Educational background in a relevant technical discipline.
  • Extensive experience with state-of-the-art upstream bioprocess technologies (including PAT) and manufacturing operations.
  • Proven project management capabilities and strong teamwork skills.
  • Exceptional interpersonal skills, with the ability to influence behaviors, negotiate, and resolve challenges effectively.
  • Outstanding data analysis, technical writing, presentation, and communication skills.
  • Hands-on experience with cGMP and FDA/EMA compliance regulations and inspections.