Senior Scientist II / Principal Research Scientist I, Laboratory Manager Engineering Testing & [...]

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience.

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 have the opportunity to address some of tomorrow's unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities for developing and increasing your own skills? You've come to the right place!

Senior Scientist II / Principal Research Scientist I, Laboratory Manager Engineering Testing & Analysis (all genders)

We are looking for a Senior Scientist II / Principal Research Scientist I, Laboratory Manager Engineering Testing & Analysis, to join our Device and Combination Product Development team.

Within Device and Combination Product Development, the Senior Scientist II / Principal Research Scientist I, Laboratory Manager Development & Design Verification Testing is responsible for leading Development, Testing and Design Verification Testing activities. The Design Inputs are based on user, product and stakeholder needs which are translated into product requirements and result in completing feasibility assessments involving prototyping and lab testing and ultimately supporting design and verification activities that result in robust devices. These devices enable the delivery of AbbVie’s innovative medicines targeted at difficult-to-cure diseases with the goal of making a remarkable impact on people’s lives.

As a Laboratory Manager Development & Design Verification Testing you would 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.

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) activities including functional performance testing of Combination Products and other studies where functional performance testing might be required.
• Demonstrate a proven leadership track record that includes the ability to influence and negotiate internally and externally as part of global teams.
• Represent ETAG as single point of contact for assigned projects in local and global teams.
• Establish and apply phase-appropriate development & testing concepts for assigned projects in a resource responsible manner.
• Promote 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).
• Validate test methods for performance testing of Combination Products.
• Conduct 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 Operating Procedures (SOPs) for the overall Quality System, training requirements and instrument qualification.
• Maintain close exchange with different program leads and interfaces at early- and late-stage Design Control process steps.
• Serve as member in global Design and Development Teams and participate in Design Reviews as Design Verification subject matter expert.
• Represent 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 the pharmaceutical industry; BS or equivalent education and extensive, 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 the pharmaceutical industry; BS or equivalent education and extensive, 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 stages.
• Expertise related to the development of combination products.
• Compliance 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.
• Proficient in MS Office and statistical knowledge.
• English fluency in spoken and written, proven skillset for interdisciplinary and intercultural teamwork.
• Excellent understanding of both scientific and regulatory requirements in the area of responsibility.

Benefits

• A diverse work environment where you can have a real impact.
• An open corporate culture.
• An attractive salary.
• An intensive onboarding process with a mentor at your side.
• Flexible work models for a healthy work‑life balance.
• A corporate health management that offers comprehensive health and exercise programs.
• Company social benefits.
• A wide range of career opportunities in an international organization.
• Top‑tier, attractive development opportunities.
• A strong international network.

Equal Opportunity Employer

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.