Overview
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address medical challenges of tomorrow. We focus on immunology, oncology, neuroscience, and the Allergan Aesthetics portfolio. For more information, visit Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
Welcome to AbbVie! As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will contribute to addressing tomorrow’s unmet medical needs in collaboration with colleagues. If you are passionate about improving global health care and patients’ quality of life through your expertise, this is the right opportunity for you.
Laboratory Manager Device and Combination Development (all genders)
Senior Scientist II / Principal Research Scientist I (all genders), Laboratory Manager Engineering Testing & Analysis, will join the Device and Combination Product Development team. Within Device and Combination Product Development, this role leads Development, Testing and Design Verification Testing activities. Design inputs are based on user, product and stakeholder needs and translate into product requirements, feasibility assessments, prototyping and lab testing, supporting design and verification activities to deliver robust devices that enable AbbVie medicines.
You will be part of a multi-disciplinary team at the intersection of engineering and biopharmaceuticals. If you are self-motivated, communicative, and excited by solving complex problems, this opportunity may be for you.
Responsibilities
- Lead the Engineering Testing & Laboratory Team (ETAG) at AbbVie Ludwigshafen Device & Combination Product Development.
- Plan, coordinate and execute Engineering Confidence- and Design Verification Testing for Parenteralia / Pharmaceutical Application Systems (Combination Products), including functional performance testing.
- Influence and negotiate effectively within global teams.
- Represent ETAG as single point of contact for assigned projects in local and global teams.
- Apply phase-appropriate development and testing concepts for assigned projects in a resource-conscious manner.
- Promote harmonized development strategies across projects and sites.
- Drive test method development per relevant standards (ISO, Pharmacopeia) and AbbVie interfaces for method comparability and release tests.
- Validate test methods for performance testing of Combination Products.
- Lead method transfers and/or co-validation with internal or external interfaces.
- Lead non-conformity investigations and issue resolutions.
- Provide the general framework and GMP/Design Control documentation; support regulatory submission content with timely data.
- Define and establish Design Verification Processes; collaborate cross-functionally on process improvements.
- Ensure GMP-compliant infrastructure, SOPs, training requirements, and Instrument Qualification.
- Collaborate with program leads and interfaces in early and late-stage Design Control steps.
- Participate in global Design and Development Teams and Design Reviews as Design Verification SME.
- Represent the area in internal and regulatory inspections.
- Demonstrate creative problem-solving and champion new technologies to achieve project goals.
Qualifications
- Senior Scientist II: University degree in biopharmaceutical sciences, engineering or related field with substantial pharmaceutical industry experience. Typical candidates have 12+ years (PhD: 4+ years; MS: 10+ years; BS: 12+ years).
- Principal Scientist I: University degree in biopharmaceutical sciences, engineering or related field with substantial pharmaceutical industry experience. Typical candidates have 14+ years (PhD: 6+ years; MS: 12+ years; BS: 14+ years).
- Experience in development of biopharmaceutical products, medical devices or combination products.
- Strong planning and coordination skills; experience with early project coordination.
- Expertise in the development of combination products.
- Compliance with applicable policies, procedures, regulatory and safety requirements; GMP experience.
- Excellent organizational and communication skills; highly motivated and thorough.
- Proficiency with MS Office and statistical tools.
- English fluent in spoken and written form; ability to work in interdisciplinary and intercultural teams.
- Solid understanding of scientific and regulatory requirements in the area of responsibility.
How We Move Mountains Together
- A diverse work environment with real impact
- Open corporate culture
- Attractive salary
- Intensive onboarding with a mentor
- Flexible work models for work-life balance
- Corporate health management and wellness programs
- Company social benefits
- Wide range of international career opportunities
- Strong development opportunities
- Extensive international network
AbbVie is an equal opportunity employer and is committed to integrity, innovation, and community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico applicants: learn more at For reasonable accommodations, visit
If you have questions, contact Talent Acquisition at AbbVie.
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