Senior Scientist II / Principal Research Scientist I – Laboratory Manager, Device & Combination Development (All Genders)
As a Laboratory Manager Development & Design Verification Testing you will be part of a multi‑disciplinary team of professionals working at the intersection of engineering and biopharmaceuticals. If you are a self‑motivated & communicative person who thrives on solving complex problems and are excited by the idea of taking on the toughest health challenges, this opportunity might be for you.
Your tasks and responsibilities:
- Lead the Engineering Testing & laboratory team (ETAG) at AbbVie Ludwigshafen Device & Combination Product Development.
- Planning, coordination and execution of Engineering Confidence‑and Design Verification Testing for Parenteralia / Pharmaceutical Application Systems (Combination Products) activities including functional performance testing of Combination Products and other studies where functional performance testing might be required.
- Proven leadership track record that includes the ability to influence and negotiate internally and externally as a part of global teams.
- Represent ETAG as single point of contact for assigned projects in local and global teams.
- Establishes and applies phase appropriate development & testing concepts for assigned projects in a resource responsible manner.
- Promotes harmonized development strategies across projects and sites.
- Drive test method development incorporating relevant standards requirements such as ISOs and/or Pharmacopeia and relevant AbbVie internal and/or external interfaces (regarding method comparability, applicable specifications, requirements for commercial process for In Process Controls and/or release tests).
- Validation of test methods for performance testing of Combination Products.
- Method Transfers and/or Co-Validation to relevant internal or external interfaces.
- Lead Non-conformity Investigations / Issue Resolutions.
- Provide general framework and guarantee documentation according to Good Manufacturing Practices (GMP) and Design Control applicable standards. Support compiling and verifying content for regulatory submission reports and providing relevant data in time.
- Define and establish Design Verification Processes. Exchange and align, where appropriate, cross‑functional. Lead through and participate in initiatives for process improvements intra- and inter departmental.
- Guarantee GMP compliant framework regarding infrastructure such as Standard Operations Processes (SOPs) for the overall Quality System, training requirements and Instrument Qualification.
- Close exchange with different program leads and –interfaces at early‑ and late‑stage Design Control process steps.
- Member in global Design and Development Teams and participation in Design Reviews as Design Verification Subject Matter Expert.
- Representative within internal and authorities inspections for the areas of responsibility.
- Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals.
Qualifications:
- Senior Scientist II: University degree in biopharmaceutical sciences, engineering or related scientific field with distinct work experience in pharmaceutical industry; BS or equivalent education and extensive experience, typically 12+ years of experience; MS or equivalent education with typically 10+ years of experience; PhD with typically 4+ years of experience in area or scientific discipline.
- Principal Scientist I: University degree in biopharmaceutical sciences, engineering or related scientific field with distinct work experience in pharmaceutical industry; BS or equivalent education and extensive experience, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific discipline.
- Experiences within development of biopharmaceutical products/medical devices/combination products.
- Strong planning and coordination skills, experience with project coordination in early.
- Expertise related to the development of combination products.
- Complies with applicable policies and procedures, regulatory and safety requirements.
- Distinct GMP experience.
- Very good organizational and communication skills, high level of self‑motivation, systematic and conscientious way of working.
- Very good MS Office and statistical knowledge.
- English fluently spoken and written, proven skillset for interdisciplinary and intercultural teamwork.
- Excellent understanding of both scientific and regulatory requirements in the area of responsibility.
Benefits:
- with a diverse work environment where you can have a real impact
- with an open corporate culture
- with an attractive salary
- with an intensive onboarding process with a mentor at your side
- with flexible work models for a healthy work‑life balance
- with a corporate health management that offers comprehensive health and exercise programs
- with company social benefits
- with a wide range of career opportunities in an international organization
- with top‑tier, attractive development opportunities
- with a strong international network
Equal Opportunity & Diversity
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only – to learn more, https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html. US & Puerto Rico applicants seeking a reasonable accommodation, https://www.abbvie.com/join-us/reasonable-accommodations.html.
