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.Experience of digital PCR (dPCR) would be advantageous.Experience of different clinical sample types and the challenges they bring to developing a diagnostic assay is highly desirable.Practical experience in microbial culture techniques is highly desirable.Must have the ability to organize, analyze and interpret data, as well as prepare high quality reports. Demonstrable troubleshooting skills with knowledge of specific statistical tools are an advantage.Experience in primer design in a diagnostic assay context is highly desirable.Excellent communication and presentation skills with a track record of tailoring communication to the target audience.Excellent written skills preparing documents fluently in English for external and internal review.Experience leading teams across multiple projects and organizing own and others' work to deliver studies/small projects to meet quality, budget and timeline requirements.Fully conversant of working in a regulated environment with quality systems and knowledge of ISO Quality standards.An agile mindset, happy working within a fast-moving R&D environment with evolving priorities.Resolve complex technical challenges in line with clinical diagnostic assay requirements, while adhering to published regulatory standards and guidance.Maintains a good understanding of health and safety in an R&D environment and a willingness to promote a safety-first culture.What we offerAt the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, supportive, and inclusive environment.
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