Senior Scientist, Molecular Assay Development

Senior Scientist, Molecular Assay Development

QIAGEN

Barcelona, Spain

Position Description

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

• 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;
• In partnership with the Technical Lead, collaborate with multidisciplinary, international teams and manage external and internal stakeholders to ensure successful project delivery and alignment with business objectives;
• 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 programs and corrective actions;
• 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 Requirements

• Degree/PhD education with 4+ years relevant work experience in molecular microbiology or infectious disease within the diagnostics field, either in IVD companies or in 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;
• Experience leading or working with 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;
• Natural ability for conducting Root Cause Investigations utilizing Design of Experiments and applying the Scientific Method;
• 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, 21CFR820, IVDR, ISO 15189, UK MDR, etc.);
• Fluent in English written and spoken, with the ability to prepare high quality reports and tailor communication to different audiences.

Highly desirable

• Experience of different clinical sample types and the challenges they bring to diagnostic assay development;
• Experience of primer design in a diagnostic assay context;
• Hands-on experience of microbial culture techniques;
• Experience of digital PCR (dPCR);
• Strong in Statistics.

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