Senior Scientist Molecular Assay Development Barcelona, Spain Permanent £ competitive depending on skills, background and experience Role profile: Working within the Molecular Assay Development team, you will be responsible for the development of new and existing molecular diagnostic applications that effectively address a range of infectious disease, utilising advanced RNA and DNA technologies.
Working closely with the Technical Lead, multidisciplinary teams and both internal and external stakeholders to deliver projects on time, in budget and in accordance with business objectives.
Lead, develop and provide technical expertise for IVD assay development projects, especially in respect of qPCR diagnostic systems and development workflows.
Data – assess, review and report data with a good understanding of its reliability, quality and traceability; interpretation of findings, draw conclusions and make recommendations to inform next steps.
Submission of files for FDA approval.
Strong and up-to-date awareness of ISO 13485, UK MDR, IVDR, ISO 15189).
Compliance and audit – create and maintain essential documentation required for regulated IVD's including compliance with Quality and Regulatory standards.
Ensure continual development of internal and external audit programmes and corrective actions.
Management of project resource, facility requirements, timelines, planning work packages for small teams of experienced scientists handling one or more studies.
Coaching and progressing staff – sharing best practice, advancements in technique, developments in the field of IVD technology.
Your background: BSc minimum (or equivalent) in a discipline related to Molecular Microbiology or Infectious Disease.
Demonstrable and relevant experience within the diagnostics sector, specifically IVD and clinical laboratory developing multiplex Lab Developed Tests (LDT) or similar.
You will have developed quantitative PCR (q PCR) and assay design, worked with IVD's in development and at verification stage.
Fluent written and spoken English and Spanish - you are able to craft high quality, compelling written reports and adjust communication to your audience in both languages.
Background in supervisory roles, leadership of small teams across a range of projects, highly organised with strong planning skills.
You enjoy creating elegant solutions to complex challenges within clinical diagnostic assay development It would be ideal to have hands-on experience of digital PCR, microbial culture techniques and primer design.
Collaborative, innovative and curious by approach.
If the above appeals to you and you can live and work in the Barcelona area, apply here or contact bec.johnstonsrgtalent.com for more information.