.OverviewAt the heart of QIAGEN's business is a vision to make improvements in life possible. We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe. Our most valuable asset are our employees - more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us. There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started. If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be. Join us. At QIAGEN, you make a difference every day.Position DescriptionKey responsibilities:In partnership with the technical lead, collaborate with multidisciplinary teams to ensure successful project delivery and alignment with business objectives while managing external and internal stakeholders.Lead and provide technical expertise in the planning and execution of IVD assay development projects, acting as a knowledge expert for quantitative PCR (qPCR) diagnostic systems and development workflows.Assess, review and report data, with a clear understanding of its reliability, quality and traceability. Interpret findings and draw authoritative conclusions and recommendations, identifying challenges and proposing improvements.Deliver essential documentation required for the development of regulated in vitro diagnostics including compliance with appropriate quality and regulatory standards.Experience working to strict quality standards and in regulated environments (ISO 13485, UK MDR, IVDR, ISO 15189 etc.).Stay up-to-date with the latest advancements in IVD technology and industry regulations.Work within a matrix environment: estimating project resource and facility requirements, analyzing the effect of resource on timelines; planning and coordinating work packages for small teams involving one or more studies.Coach and mentor staff to ensure continuous development, sharing knowledge and best practices to build and nurture a connected and effective team.Position RequirementsDegree/PhD education with at least 6-8 years relevant work experience in molecular microbiology or infectious disease ideally within the diagnostics field, with 2-3 years in a clinical laboratory testing and LDT multiplex development environment or other IVD development context.Ensure the continual development and compliance of internal and external audit programmes and corrective actions.Experience of quantitative PCR (qPCR) assay design; IVD development and verification experience are essential
