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Manager CQV and Start-up Operations Readiness(m/w/x)
Leading senior CQV experts for biopharma facility start-up and OQ support in biologics manufacturing, establishing a local Center of Excellence. Recognized expertise in biopharma facility qualification/validation and extensive start-up experience required. Relocation assistance provided.
Anforderungen
- Bachelor's or Master's degree in relevant field
- Recognized expertise in biopharma facility qualification/validation
- Deep understanding of bioprocesses, GMP, biopharmaceutical manufacturing
- Extensive experience in biopharma facility start-up
- Strong leadership capabilities and team development
- Excellent communication, business acumen, team orientation
- Structured, proactive, solution-oriented working style
- Open-mindedness, receptiveness to new ideas, commitment to improvement
Aufgaben
- Lead and develop a team of senior CQV experts
- Manage team hiring, coaching, and performance
- Handle team compensation and disciplinary matters
- Establish and manage a local Center of Excellence
- Provide OQ support for biologics facilities
- Lead PQ for biologics facilities
- Provide operational user support during qualification and start-up
- Ensure strong operations input into commissioning activities
- Ensure strong operations input into qualification activities
- Contribute expert knowledge to capital investment projects
- Strengthen operations teams during qualification and start-up
- Drive operational start-up planning in early project phases
- Define CQV and start-up resource plans with Operations Heads
- Coordinate and facilitate start-up activities
- Manage start-up tools, procedures, and processes
- Provide start-up services to end users
- Standardize the PQ approach for GMP readiness
- Build and manage a pool of external resources
- Promote Lonza culture via collaboration and improvement
- Represent the area in the Ibex Readiness Leadership Team
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Boni & Prämien
- Performance compensation programs
Sonstige Vorteile
- Relocation assistance
Karriere- und Weiterentwicklung
- Agile career
Lockere Unternehmenskultur
- Dynamic working culture
Sinnstiftende Arbeit
- Inclusive and ethical workplace
Noch nicht perfekt?
- CH12 Lonza AGVollzeitnur vor OrtSeniorVisp
- Lonza
Head of CQV/CSV - Advanced Synthesis Conjugates(m/w/x)
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Qualification CQV Engineer(m/w/x)
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CQV Engineer / Qualification & Validation Engineer(m/w/x)
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Team Lead CSV Biologics(m/w/x)
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Manager CQV and Start-up Operations Readiness(m/w/x)
Leading senior CQV experts for biopharma facility start-up and OQ support in biologics manufacturing, establishing a local Center of Excellence. Recognized expertise in biopharma facility qualification/validation and extensive start-up experience required. Relocation assistance provided.
Anforderungen
- Bachelor's or Master's degree in relevant field
- Recognized expertise in biopharma facility qualification/validation
- Deep understanding of bioprocesses, GMP, biopharmaceutical manufacturing
- Extensive experience in biopharma facility start-up
- Strong leadership capabilities and team development
- Excellent communication, business acumen, team orientation
- Structured, proactive, solution-oriented working style
- Open-mindedness, receptiveness to new ideas, commitment to improvement
Aufgaben
- Lead and develop a team of senior CQV experts
- Manage team hiring, coaching, and performance
- Handle team compensation and disciplinary matters
- Establish and manage a local Center of Excellence
- Provide OQ support for biologics facilities
- Lead PQ for biologics facilities
- Provide operational user support during qualification and start-up
- Ensure strong operations input into commissioning activities
- Ensure strong operations input into qualification activities
- Contribute expert knowledge to capital investment projects
- Strengthen operations teams during qualification and start-up
- Drive operational start-up planning in early project phases
- Define CQV and start-up resource plans with Operations Heads
- Coordinate and facilitate start-up activities
- Manage start-up tools, procedures, and processes
- Provide start-up services to end users
- Standardize the PQ approach for GMP readiness
- Build and manage a pool of external resources
- Promote Lonza culture via collaboration and improvement
- Represent the area in the Ibex Readiness Leadership Team
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Boni & Prämien
- Performance compensation programs
Sonstige Vorteile
- Relocation assistance
Karriere- und Weiterentwicklung
- Agile career
Lockere Unternehmenskultur
- Dynamic working culture
Sinnstiftende Arbeit
- Inclusive and ethical workplace
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.
Noch nicht perfekt?
- CH12 Lonza AG
Associate Director CQV Integrated Biologics(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Head of CQV/CSV - Advanced Synthesis Conjugates(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Qualification CQV Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenVisp - CH12 Lonza AG
CQV Engineer / Qualification & Validation Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenVisp - Lonza
Team Lead CSV Biologics(m/w/x)
Vollzeitnur vor OrtSeniorVisp