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Upstream Manufacturing Expert Lead
vor 2 Wochen
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:
- Coordinate technical and laboratory activities in support of technology transfer, continued cGMP manufacturing, and process improvements.
- Provide guidance on USP Process Transfer & Sciences SME activities, including GMS lab operations and studies.
- Lead cross-functional project teams to facilitate process transfer, validation, and process life cycle activities.
- Ensure technical manufacturing support through process monitoring, issue resolution, and participation in operations governance huddles.
- 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.