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. 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. 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 DescriptionQIAGEN Barcelona is a world leading centre for syndromic diagnostic applications, expanding and enhancing the delivery of life improving diagnostic systems for existing and emerging medical needs focusing on infectious disease.We currently have a fantastic opportunity for a Senior Scientist within our Molecular Assay Design and Development team supporting the development of new and existing molecular diagnostic applications utilizing state of the art RNA and DNA technologies.Key responsibilities:In partnership with the Technical Lead, collaborate with multidisciplinary teams and manage external and internal stakeholders to ensure successful project delivery and alignment with business objectives.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 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. Ensure the continual development and compliance of internal and external audit programmes and corrective actions.Work within a matrix environment: estimating project resource and facility requirements, analysing the effect of resource on timelines; planning and coordinating work packages for small teams involving one or more studies. This includes the ability to work across departmental boundaries and influence others to effectively and efficiently deliver projects.Coach and mentor staff to ensure continuous development, sharing knowledge and best practices in order to build and nurture a connected and effective team. Stay up-to-date with the latest advancements in IVD technology and industry regulations.Position RequirementsDegree/PhD education with 4+ years relevant work experience in molecular microbiology or infectious disease within the diagnostics field ie. within a clinical laboratory developing multiplex Lab Developed Tests (LDT) or other IVD development context.Experience of quantitative PCR (qPCR) assay design; IVD development and verification.Fluent English and Spanish, written and spoken, with the ability to prepare high quality reports and tailor communication to different audiences.Experience leading teams across multiple projects and organizing own and others' work to deliver studies/ small projects to meet quality, budget and timeline requirements. Planning experience with resourcing tools would be highly desirable.Ability to resolve complex technical challenges in line with clinical diagnostic assay requirements, while adhering to published regulatory standards and guidance. Fully conversant of working in a regulated environment with quality systems and knowledge of ISO Quality standards (ISO 13485, UK MDR, IVDR, ISO 15189 etc.).A good understanding of health and safety in an R&D environment and a willingness to promote a safety-first culture.Highly desirable:Experience of digital PCR (dPCR)Experience of different clinical sample types and the challenges they bring to diagnostic assay developmentHands-on experience of microbial culture techniquesExperience of primer design in a diagnostic assay contextWhat 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 create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN. QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability. Job Reference: EMEA04640
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