Laboratory Manager - Device and Combination Development (all genders) (full-time, permanent)

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The job that makes possibilities real in patients' lives. And yours. The job that helps you get ahead in life. Moving mountains together. 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 of addressing some of tomorrows 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 of developing and increasing your own skills? Youve come to the right place! Moving mountains together - as Laboratory Manager - Device and Combination Development (all genders) We are looking for a Senior Scientist II / Principal Research Scientist I (all genders), 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. 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. Represents 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 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, Typically, 12+ years of experience; MS or equivalent education with typically 10+ years of experience; PhD with typically 4+ years of experien

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