AbbVie
Laboratory Manager - Device and Combination Development(m/w/x)
Full-timeOn-siteExperienced
Ludwigshafen am Rhein
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ABAbbVie
Laboratory Manager - Device and Combination Development(m/w/x)
Ludwigshafen am Rhein
Full-timeOn-siteExperienced
Nejo AI Summary
Leading Engineering Testing & Analysis team for combination product functional performance testing. Expertise in biopharmaceutical product development required. Flexible work models, intensive onboarding with mentor.
Requirements
- 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
Tasks
- 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
Work Experience
- 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
Tools & Technologies
- MS Office
Benefits
Informal Culture
- Diverse work environment
- Open corporate culture
- International network
- Great Place to Work recognition
Mentorship & Coaching
- Intensive onboarding with mentor
Flexible Working
- Flexible work models
- Healthy work-life balance
Healthcare & Fitness
- Corporate health management
Other Benefits
- Company social benefits
- Equality, equity, diversity and inclusion
Career Advancement
- Career opportunities
Learning & Development
- Development opportunities
Sustainability Focus
- Environmental and community focus
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of AbbVie and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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ABAbbVie
Laboratory Manager - Device and Combination Development(m/w/x)
Ludwigshafen am Rhein
Full-timeOn-siteExperienced
Nejo AI Summary
Leading Engineering Testing & Analysis team for combination product functional performance testing. Expertise in biopharmaceutical product development required. Flexible work models, intensive onboarding with mentor.
Requirements
- 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
Tasks
- 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
Work Experience
- 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
Tools & Technologies
- MS Office
Benefits
Informal Culture
- Diverse work environment
- Open corporate culture
- International network
- Great Place to Work recognition
Mentorship & Coaching
- Intensive onboarding with mentor
Flexible Working
- Flexible work models
- Healthy work-life balance
Healthcare & Fitness
- Corporate health management
Other Benefits
- Company social benefits
- Equality, equity, diversity and inclusion
Career Advancement
- Career opportunities
Learning & Development
- Development opportunities
Sustainability Focus
- Environmental and community focus
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of AbbVie and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
AbbVie
Industry
Pharmaceuticals
Description
Das Unternehmen setzt sich für die Entdeckung und Bereitstellung innovativer Medikamente und Lösungen ein, die ernsthafte Gesundheitsprobleme lösen.
Not a perfect match?
- AbbVie
Laboratory Manager - Device and Combination Development(m/w/x)
Full-timeOn-siteExperiencedLudwigshafen am Rhein - AbbVie
Drug Product Lead(m/w/x)
Full-timeOn-siteSeniorLudwigshafen am Rhein - AbbVie
Laborleiter Qualitätskontrolle Chromatographie(m/w/x)
Full-timeOn-siteExperiencedLudwigshafen am Rhein - Roche Diabetes Care GmbH
Teamlead QC-Labor(m/w/x)
Full-timeOn-siteSeniorMannheim - AbbVie
Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)
Full-time/Part-timeOn-siteSeniorLudwigshafen am Rhein