Takeda Manufacturing Austria AG
Associate Director, API Process Engineering(m/w/x)
Full-timeOn-siteManagement
Zürich, Neuenburg, Oranienburg
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
CSCSL Vifor
Director, CMC Strategy and Tech Transfer(m/w/x)
Zürich
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Defining end-to-end CMC strategy and overseeing tech transfer for iron deficiency and nephrology therapies. Advanced degree in a science field required, MBA a plus. Well-being support and global manufacturing network exposure.
Anforderungen
- Advanced degree (PhD, MSc, or equivalent) in Chemical Engineering, Biotechnology, Pharmacy, or related field
- MBA is a plus
- Strong experience in CMC strategy, technology transfer, and manufacturing
- Proven leadership in regulatory submissions and health authority interactions
- Extensive experience with CDMOs and global manufacturing networks
- Deep expertise in CMC development and lifecycle management
- Strong understanding of biologics and/or small molecule processes
- Expertise in GMP, validation, and regulatory requirements
- Strategic thinking with strong execution capability
- Excellent leadership and stakeholder management skills
- Strong business acumen and risk-based decision making
Aufgaben
- Define and drive end-to-end CMC strategy
- Align CMC plans with program strategy and timelines
- Lead CMC contributions to regulatory submissions
- Advise senior leadership on CMC risks and decisions
- Provide executive oversight of technology transfer
- Ensure robust transfer strategies and validation
- Oversee transfers to and from CDMOs and global sites
- Ensure readiness of receiving units
- Align Process Development, MS&T, and Manufacturing
- Guide process characterization and lifecycle management
- Drive manufacturing readiness for clinical and commercial supply
- Ensure compliance with global regulatory expectations
- Oversee preparation and review of CMC sections
- Represent CMC during health authority interactions
- Define external manufacturing and development strategy
- Select and oversee CDMOs
- Establish governance models for performance and quality
- Identify and mitigate key CMC risks
- Lead cross-functional decision-making for CMC challenges
- Ensure continuity of supply and inspection readiness
- Lead and develop a team of scientists and engineers
- Foster a culture of technical excellence and collaboration
- Influence cross-functional teams without direct authority
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 Vifor 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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CSCSL Vifor
Director, CMC Strategy and Tech Transfer(m/w/x)
Zürich
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Defining end-to-end CMC strategy and overseeing tech transfer for iron deficiency and nephrology therapies. Advanced degree in a science field required, MBA a plus. Well-being support and global manufacturing network exposure.
Anforderungen
- Advanced degree (PhD, MSc, or equivalent) in Chemical Engineering, Biotechnology, Pharmacy, or related field
- MBA is a plus
- Strong experience in CMC strategy, technology transfer, and manufacturing
- Proven leadership in regulatory submissions and health authority interactions
- Extensive experience with CDMOs and global manufacturing networks
- Deep expertise in CMC development and lifecycle management
- Strong understanding of biologics and/or small molecule processes
- Expertise in GMP, validation, and regulatory requirements
- Strategic thinking with strong execution capability
- Excellent leadership and stakeholder management skills
- Strong business acumen and risk-based decision making
Aufgaben
- Define and drive end-to-end CMC strategy
- Align CMC plans with program strategy and timelines
- Lead CMC contributions to regulatory submissions
- Advise senior leadership on CMC risks and decisions
- Provide executive oversight of technology transfer
- Ensure robust transfer strategies and validation
- Oversee transfers to and from CDMOs and global sites
- Ensure readiness of receiving units
- Align Process Development, MS&T, and Manufacturing
- Guide process characterization and lifecycle management
- Drive manufacturing readiness for clinical and commercial supply
- Ensure compliance with global regulatory expectations
- Oversee preparation and review of CMC sections
- Represent CMC during health authority interactions
- Define external manufacturing and development strategy
- Select and oversee CDMOs
- Establish governance models for performance and quality
- Identify and mitigate key CMC risks
- Lead cross-functional decision-making for CMC challenges
- Ensure continuity of supply and inspection readiness
- Lead and develop a team of scientists and engineers
- Foster a culture of technical excellence and collaboration
- Influence cross-functional teams without direct authority
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 Vifor 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 Vifor
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globaler Partner für pharmazeutische Produkte und innovative Therapien in der Eisenmangel- und Nephrologie.
Not a perfect match?
- Takeda Manufacturing Austria AG
Associate Director, API Process Engineering(m/w/x)
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Full-timeOn-siteSeniorZürich - CSL Behring
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Full-timeOn-siteManagementSchlieren - SIEGFRIED DiNAMIQS AG
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