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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
- Englisch – verhandlungssicher
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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
- Englisch – verhandlungssicher
Über das Unternehmen
Lonza
Branche
Pharmaceuticals
Beschreibung
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
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