Lonza
Head Manufacturing for Lyophilized Vials in a Growth Project(m/w/x)
Vollzeitnur vor OrtManagement
Stein (AR)
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LOLonza
Senior Global Technology Transfer Lead(m/w/x)
Stein (AR)
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Overseeing process setup and scale-up for medicine manufacturing across 30+ global sites. Industry-leading expertise in aseptic protein drug product manufacturing highly desirable. Global coordination across 30+ manufacturing sites.
Anforderungen
- MSc or PhD in Pharmaceutical Sciences, Engineering, Chemistry, Biochemistry, Bioengineering, or related field
- Ability to translate scientific depth into strategic decision-making
- Industry-leading expertise in biotech/pharma/CDMO; drug product development, technology transfer, aseptic product manufacture of protein drug products, lyophilization process highly desirable and/or manufacturing experience in prefilled syringes
- Ability to influence platform strategy and drive innovation in complex operational environments
- Deep knowledge of GMP, regulatory expectations, and CMC requirements for late-stage and commercial biologics
- Capability in translating program objectives into robust operational manufacturing processes
- Excellent communication, stakeholder management, and supervisory skills; ability to influence senior/executive levels
- Strong command of risk management and scenario planning
- Exemplary planning and organizing skills, including project management, risk management, interpretation and communication of complex scientific data, technical writing skills
- Experience driving manufacturing strategy, resolving high-impact technical issues, and overseeing cross-site initiatives
- Excellent written and oral English communication skills
- German language skills (advantage)
Aufgaben
- Lead harmonization and standardization across sites
- Oversee process setup and scale-up
- Oversee GMP change management
- Oversee on-site technical support during execution
- Guide manufacturing strategy
- Ensure compliance with global standards
- Enable seamless transfer of complex projects
- Enable seamless implementation of complex projects
- Manage end-to-end commercial drug product transfers
- Act as global Subject Matter Expert for Tech Transfer
- Shape technical strategy
- Ensure global standard alignment
- Drive customer-centric excellence across sites
- Drive customer-centric excellence across product lifecycles
- Provide technical authority
- Serve as senior escalation point for technical challenges
- Provide tech transfer leadership for late-phase programs
- Provide tech transfer leadership for commercial programs
- Serve as primary technical contact for technology transfer topics
- Liaise with internal and customer project teams
- Define and monitor project scope
- Define and monitor project timing
- Define and monitor project progress
- Lead process setup and scale-up activities
- Lead implementation activities at GMP sites
- Provide on-site technical support during batch execution
- Manage new product introduction
- Manage process implementation documentation
- Develop process control strategy
- Prepare technical transfer documentation
- Prepare process validation documentation
- Review dossier modules for regulatory filing
- Drive GMP change management strategy
- Initiate and manage GMP change control
- Lead and support critical GMP deviations
- Implement corrective and preventive actions (CAPAs)
- Ensure compliance with GMP, HSE, and regulatory standards
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Benefits
Boni & Prämien
- Performance-based compensation programs
Karriere- und Weiterentwicklung
- Agile career
Startup-Atmosphäre
- Dynamic work culture
Lockere Unternehmenskultur
- Collaborative environment
Sinnstiftende Arbeit
- Inclusive and ethical workplace
Sonstige Vorteile
- Relocation assistance
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Lonza 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.
Noch nicht perfekt?
- CH12 Lonza AG
Head MSAT, Drug Product Stein(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR) - CH12 Lonza AG
Global MSAT Drug Product Qualification and Validation Lead(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR) - Lonza
MSAT Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenStein (AR) - Lonza
Global MSAT Lyophilization Equipment and Process Lead(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR)
LOLonza
Senior Global Technology Transfer Lead(m/w/x)
Stein (AR)
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Overseeing process setup and scale-up for medicine manufacturing across 30+ global sites. Industry-leading expertise in aseptic protein drug product manufacturing highly desirable. Global coordination across 30+ manufacturing sites.
Anforderungen
- MSc or PhD in Pharmaceutical Sciences, Engineering, Chemistry, Biochemistry, Bioengineering, or related field
- Ability to translate scientific depth into strategic decision-making
- Industry-leading expertise in biotech/pharma/CDMO; drug product development, technology transfer, aseptic product manufacture of protein drug products, lyophilization process highly desirable and/or manufacturing experience in prefilled syringes
- Ability to influence platform strategy and drive innovation in complex operational environments
- Deep knowledge of GMP, regulatory expectations, and CMC requirements for late-stage and commercial biologics
- Capability in translating program objectives into robust operational manufacturing processes
- Excellent communication, stakeholder management, and supervisory skills; ability to influence senior/executive levels
- Strong command of risk management and scenario planning
- Exemplary planning and organizing skills, including project management, risk management, interpretation and communication of complex scientific data, technical writing skills
- Experience driving manufacturing strategy, resolving high-impact technical issues, and overseeing cross-site initiatives
- Excellent written and oral English communication skills
- German language skills (advantage)
Aufgaben
- Lead harmonization and standardization across sites
- Oversee process setup and scale-up
- Oversee GMP change management
- Oversee on-site technical support during execution
- Guide manufacturing strategy
- Ensure compliance with global standards
- Enable seamless transfer of complex projects
- Enable seamless implementation of complex projects
- Manage end-to-end commercial drug product transfers
- Act as global Subject Matter Expert for Tech Transfer
- Shape technical strategy
- Ensure global standard alignment
- Drive customer-centric excellence across sites
- Drive customer-centric excellence across product lifecycles
- Provide technical authority
- Serve as senior escalation point for technical challenges
- Provide tech transfer leadership for late-phase programs
- Provide tech transfer leadership for commercial programs
- Serve as primary technical contact for technology transfer topics
- Liaise with internal and customer project teams
- Define and monitor project scope
- Define and monitor project timing
- Define and monitor project progress
- Lead process setup and scale-up activities
- Lead implementation activities at GMP sites
- Provide on-site technical support during batch execution
- Manage new product introduction
- Manage process implementation documentation
- Develop process control strategy
- Prepare technical transfer documentation
- Prepare process validation documentation
- Review dossier modules for regulatory filing
- Drive GMP change management strategy
- Initiate and manage GMP change control
- Lead and support critical GMP deviations
- Implement corrective and preventive actions (CAPAs)
- Ensure compliance with GMP, HSE, and regulatory standards
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Benefits
Boni & Prämien
- Performance-based compensation programs
Karriere- und Weiterentwicklung
- Agile career
Startup-Atmosphäre
- Dynamic work culture
Lockere Unternehmenskultur
- Collaborative environment
Sinnstiftende Arbeit
- Inclusive and ethical workplace
Sonstige Vorteile
- Relocation assistance
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Lonza 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.
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?
- Lonza
Head Manufacturing for Lyophilized Vials in a Growth Project(m/w/x)
Vollzeitnur vor OrtManagementStein (AR) - CH12 Lonza AG
Head MSAT, Drug Product Stein(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR) - CH12 Lonza AG
Global MSAT Drug Product Qualification and Validation Lead(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR) - Lonza
MSAT Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenStein (AR) - Lonza
Global MSAT Lyophilization Equipment and Process Lead(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR)