AbbVie
Laboratory Manager - Device and Combination Development(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Ludwigshafen am Rhein
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ABAbbVie
Laboratory Manager - Device and Combination Development(m/w/x)
Ludwigshafen am Rhein
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Leading Engineering Testing & Analysis team for combination product functional performance testing. Expertise in biopharmaceutical product development required. Flexible work models, intensive onboarding with mentor.
Anforderungen
- University degree in biopharmaceutical sciences, engineering or related scientific field
- 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, procedures, 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
- Fluent English 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 the Engineering Testing & Analysis (ETAG) team
- Plan and coordinate Engineering Confidence and Design Verification Testing
- Execute functional performance testing for Combination Products
- Conduct other studies requiring functional performance testing
- 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 ISO and Pharmacopeia standards
- Validate test methods for Combination Product performance testing
- Transfer and co-validate test methods to internal and external interfaces
- Lead non-conformity investigations and issue resolutions
- Ensure documentation complies with GMP and Design Control standards
- Support regulatory submission reports and provide relevant data
- Define and establish Design Verification Processes
- Collaborate cross-functionally for process improvements
- Guarantee GMP compliance for infrastructure and Quality System
- Ensure training requirements and Instrument Qualification
- Engage with program leads and interfaces in Design Control process
- Participate in global Design and Development Teams
- Conduct Design Reviews as a Design Verification Subject Matter Expert
- Represent the team during internal and authority inspections
- Solve complex technical problems creatively
- Champion new technologies to achieve project goals
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
- Healthy work-life balance
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.
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ABAbbVie
Laboratory Manager - Device and Combination Development(m/w/x)
Ludwigshafen am Rhein
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Leading Engineering Testing & Analysis team for combination product functional performance testing. Expertise in biopharmaceutical product development required. Flexible work models, intensive onboarding with mentor.
Anforderungen
- University degree in biopharmaceutical sciences, engineering or related scientific field
- 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, procedures, 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
- Fluent English 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 the Engineering Testing & Analysis (ETAG) team
- Plan and coordinate Engineering Confidence and Design Verification Testing
- Execute functional performance testing for Combination Products
- Conduct other studies requiring functional performance testing
- 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 ISO and Pharmacopeia standards
- Validate test methods for Combination Product performance testing
- Transfer and co-validate test methods to internal and external interfaces
- Lead non-conformity investigations and issue resolutions
- Ensure documentation complies with GMP and Design Control standards
- Support regulatory submission reports and provide relevant data
- Define and establish Design Verification Processes
- Collaborate cross-functionally for process improvements
- Guarantee GMP compliance for infrastructure and Quality System
- Ensure training requirements and Instrument Qualification
- Engage with program leads and interfaces in Design Control process
- Participate in global Design and Development Teams
- Conduct Design Reviews as a Design Verification Subject Matter Expert
- Represent the team during internal and authority inspections
- Solve complex technical problems creatively
- Champion new technologies to achieve project goals
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
- Healthy work-life balance
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
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Laborleiter Qualitätskontrolle Chromatographie(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLudwigshafen am Rhein - Roche Diagnostics GmbH
Teamlead QC Biotesting Process Monitoring & Validation(m/w/x)
Vollzeitnur vor OrtSeniorMannheim - AbbVie
Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)
Vollzeit/Teilzeitnur vor OrtSeniorLudwigshafen am Rhein