AbbVie
Laboratory Manager - Device and Combination Development(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Ludwigshafen am Rhein
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
ABAbbVie
Laboratory Manager - Device and Combination Development(m/w/x)
Ludwigshafen am Rhein
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Leading engineering testing and analysis for combination products, including functional performance testing. Pharmaceutical industry experience with biopharmaceutical product development required. Flexible work models, intensive onboarding with mentor.
Anforderungen
- University degree in biopharmaceutical sciences, engineering or related scientific field
- Work experience in pharmaceutical industry
- Experience in development of biopharmaceutical products/medical devices/combination products
- Strong planning and coordination skills
- Project coordination experience in early stages
- Expertise in development of combination products
- Compliance with policies and procedures
- Compliance with regulatory and safety requirements
- Distinct GMP experience
- Very good organizational skills
- Very good communication skills
- High level of self-motivation
- Systematic and conscientious way of working
- Very good MS Office knowledge
- Very good statistical knowledge
- English fluent in spoken and written
- Proven skillset for interdisciplinary teamwork
- Proven skillset for intercultural teamwork
- Excellent understanding of scientific requirements
- Excellent understanding of regulatory requirements
- Proven leadership track record
- Ability to influence and negotiate internally and externally
Aufgaben
- Lead Engineering Testing & Analysis team
- Plan and coordinate Engineering Confidence and Design Verification Testing
- Execute functional performance testing for Combination Products
- Represent ETAG in local and global project teams
- Establish phase-appropriate development and testing concepts
- Promote harmonized development strategies across projects and sites
- Develop test methods incorporating relevant standards
- Validate test methods for performance testing
- Transfer and co-validate test methods to internal and external interfaces
- Lead non-conformity investigations and issue resolutions
- Ensure documentation compliance with GMP and Design Control standards
- Support regulatory submission reports and data provision
- Define and establish Design Verification Processes
- Collaborate cross-functionally for process improvements
- Guarantee GMP compliance for infrastructure and Quality System
- Engage with program leads and interfaces in Design Control process
- Participate in global Design and Development Teams
- Conduct Design Reviews as a Subject Matter Expert
- Represent the team during internal and authority inspections
- Solve technical problems creatively and champion new technologies
Berufserfahrung
- 4 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
Tools & Technologien
- MS Office
Benefits
Lockere Unternehmenskultur
- Diverse work environment
- Open corporate culture
- International network
- Great Place to Work recognition
Mentoring & Coaching
- Intensive onboarding with mentor
Flexibles Arbeiten
- Flexible work models
Gesundheits- & Fitnessangebote
- Corporate health management
Sonstige Vorteile
- Company social benefits
- Equality, equity, diversity and inclusion
Karriere- und Weiterentwicklung
- Career opportunities
Weiterbildungsangebote
- Development opportunities
Fokus auf Nachhaltigkeit
- Environmental and community focus
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AbbVie 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.
Noch nicht perfekt?
- AbbVie
Drug Product Lead(m/w/x)
Vollzeitnur vor OrtSeniorLudwigshafen am Rhein - AbbVie
Laborleiter Qualitätskontrolle Chromatographie(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLudwigshafen am Rhein - AbbVie
Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)
Vollzeit/Teilzeitnur vor OrtSeniorLudwigshafen am Rhein - Roche Diagnostics GmbH
Teamlead QC Biotesting Process Monitoring & Validation(m/w/x)
Vollzeitnur vor OrtSeniorMannheim
ABAbbVie
Laboratory Manager - Device and Combination Development(m/w/x)
Ludwigshafen am Rhein
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Leading engineering testing and analysis for combination products, including functional performance testing. Pharmaceutical industry experience with biopharmaceutical product development required. Flexible work models, intensive onboarding with mentor.
Anforderungen
- University degree in biopharmaceutical sciences, engineering or related scientific field
- Work experience in pharmaceutical industry
- Experience in development of biopharmaceutical products/medical devices/combination products
- Strong planning and coordination skills
- Project coordination experience in early stages
- Expertise in development of combination products
- Compliance with policies and procedures
- Compliance with regulatory and safety requirements
- Distinct GMP experience
- Very good organizational skills
- Very good communication skills
- High level of self-motivation
- Systematic and conscientious way of working
- Very good MS Office knowledge
- Very good statistical knowledge
- English fluent in spoken and written
- Proven skillset for interdisciplinary teamwork
- Proven skillset for intercultural teamwork
- Excellent understanding of scientific requirements
- Excellent understanding of regulatory requirements
- Proven leadership track record
- Ability to influence and negotiate internally and externally
Aufgaben
- Lead Engineering Testing & Analysis team
- Plan and coordinate Engineering Confidence and Design Verification Testing
- Execute functional performance testing for Combination Products
- Represent ETAG in local and global project teams
- Establish phase-appropriate development and testing concepts
- Promote harmonized development strategies across projects and sites
- Develop test methods incorporating relevant standards
- Validate test methods for performance testing
- Transfer and co-validate test methods to internal and external interfaces
- Lead non-conformity investigations and issue resolutions
- Ensure documentation compliance with GMP and Design Control standards
- Support regulatory submission reports and data provision
- Define and establish Design Verification Processes
- Collaborate cross-functionally for process improvements
- Guarantee GMP compliance for infrastructure and Quality System
- Engage with program leads and interfaces in Design Control process
- Participate in global Design and Development Teams
- Conduct Design Reviews as a Subject Matter Expert
- Represent the team during internal and authority inspections
- Solve technical problems creatively and champion new technologies
Berufserfahrung
- 4 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
Tools & Technologien
- MS Office
Benefits
Lockere Unternehmenskultur
- Diverse work environment
- Open corporate culture
- International network
- Great Place to Work recognition
Mentoring & Coaching
- Intensive onboarding with mentor
Flexibles Arbeiten
- Flexible work models
Gesundheits- & Fitnessangebote
- Corporate health management
Sonstige Vorteile
- Company social benefits
- Equality, equity, diversity and inclusion
Karriere- und Weiterentwicklung
- Career opportunities
Weiterbildungsangebote
- Development opportunities
Fokus auf Nachhaltigkeit
- Environmental and community focus
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AbbVie 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
AbbVie
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen setzt sich für die Entdeckung und Bereitstellung innovativer Medikamente und Lösungen ein, die ernsthafte Gesundheitsprobleme lösen.
Noch nicht perfekt?
- AbbVie
Laboratory Manager - Device and Combination Development(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLudwigshafen am Rhein - AbbVie
Drug Product Lead(m/w/x)
Vollzeitnur vor OrtSeniorLudwigshafen am Rhein - AbbVie
Laborleiter Qualitätskontrolle Chromatographie(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLudwigshafen am Rhein - AbbVie
Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)
Vollzeit/Teilzeitnur vor OrtSeniorLudwigshafen am Rhein - Roche Diagnostics GmbH
Teamlead QC Biotesting Process Monitoring & Validation(m/w/x)
Vollzeitnur vor OrtSeniorMannheim