CSL Behring
Scientist, Process Development, Tech Ops(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Bern
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CSCSL Behring
Director, Process Development(m/w/x)
Bern
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading Albumin downstream process development and optimization for biotherapeutics. PhD or Master’s with GMP and regulatory framework understanding required. Well-being support and global biotherapeutics leadership.
Anforderungen
- PhD or Master’s in Biotechnology, Biochemical/Chemical Engineering, or related field
- Strong downstream processing expertise
- Proven scale-up, tech transfer, and manufacturing support experience
- Deep GMP and regulatory frameworks understanding (FDA, EMA)
- Demonstrated leadership and team management experience
- Preferable understanding of plasma process development
- Deep technical expertise in bioprocessing
- Strategic leadership and decision-making skills
- Strong problem-solving and analytical skills
- Cross-functional collaboration and stakeholder management
- Innovation and continuous improvement mindset
Aufgaben
- Lead development of Albumin downstream processes
- Optimize process yield, quality, and scalability
- Establish critical process parameters and quality attributes
- Oversee scale-up from lab to pilot and commercial manufacturing
- Lead technology transfer to manufacturing sites and external partners
- Ensure process consistency and robustness across scales and sites
- Provide expertise in biologics production systems
- Drive innovation and adoption of new bioprocessing technologies
- Lead troubleshooting and resolution of complex process challenges
- Ensure compliance with GMP and global regulatory expectations
- Support regulatory submissions with process development data
- Act as SME during inspections and audits
- Partner with MS&T, Manufacturing, Analytical Development, Quality, and Regulatory teams
- Align process strategies with product and portfolio goals
- Lead and mentor multidisciplinary teams
- Manage budgets, resources, and project priorities
- Build a high-performing, innovative team culture
- Support process validation and continued process verification
- Drive process optimization using data analytics and statistical tools
- Implement improvements post-commercialization
Berufserfahrung
- 12 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mentale Gesundheitsförderung
- Well-being support
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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Bern
VollzeitVor OrtSenior
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Leading Albumin downstream process development and optimization for biotherapeutics. PhD or Master’s with GMP and regulatory framework understanding required. Well-being support and global biotherapeutics leadership.
Anforderungen
- PhD or Master’s in Biotechnology, Biochemical/Chemical Engineering, or related field
- Strong downstream processing expertise
- Proven scale-up, tech transfer, and manufacturing support experience
- Deep GMP and regulatory frameworks understanding (FDA, EMA)
- Demonstrated leadership and team management experience
- Preferable understanding of plasma process development
- Deep technical expertise in bioprocessing
- Strategic leadership and decision-making skills
- Strong problem-solving and analytical skills
- Cross-functional collaboration and stakeholder management
- Innovation and continuous improvement mindset
Aufgaben
- Lead development of Albumin downstream processes
- Optimize process yield, quality, and scalability
- Establish critical process parameters and quality attributes
- Oversee scale-up from lab to pilot and commercial manufacturing
- Lead technology transfer to manufacturing sites and external partners
- Ensure process consistency and robustness across scales and sites
- Provide expertise in biologics production systems
- Drive innovation and adoption of new bioprocessing technologies
- Lead troubleshooting and resolution of complex process challenges
- Ensure compliance with GMP and global regulatory expectations
- Support regulatory submissions with process development data
- Act as SME during inspections and audits
- Partner with MS&T, Manufacturing, Analytical Development, Quality, and Regulatory teams
- Align process strategies with product and portfolio goals
- Lead and mentor multidisciplinary teams
- Manage budgets, resources, and project priorities
- Build a high-performing, innovative team culture
- Support process validation and continued process verification
- Drive process optimization using data analytics and statistical tools
- Implement improvements post-commercialization
Berufserfahrung
- 12 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mentale Gesundheitsförderung
- Well-being support
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
CSL Behring
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
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