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Diagnostic Scientist Tissue Diagnostics

AstraZeneca
Job LocationSaffron Walden
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Do you feel passionate about the possibilities of science to change livesHere at AstraZeneca, you’ll have the opportunity to make a difference in people’s lives every single day. As one of the world’s premier biotechnology companies, our mission is centred on delivering life-changing products that advance world health and help fight and cure disease. AstraZeneca has a dynamic environment that cultivates collaboration and innovation. We attract top minds, and we champion and build top talent.Precision Medicine within AstraZeneca focuses on matching medicines to those patients who will benefit from them most and delivers companion or complementary diagnostic assays that align with the drug development process and enable personalised healthcare approaches within our clinical portfolio.If successful youd provide scientific and regulatory tissue diagnostic expertise and delivery to drug project teams following a diagnostics approach. Specifically, youd be 1. accountable for the delivery of work packages involving the development of diagnostics as agreed with project leaders. 2. Accountable for delivering diagnostic science to enable diagnostic launch. 3. Accountable for scientific and regulatory aspects of diagnostic test establishment in testing laboratories, quality control for the delivery to clinical studies and delivery of data packages to enable regulatory approvals including studies to support market adoption and life cycle management. You would ensure that all activities are delivered demonstrating behaviours and values aligned to AstraZeneca Code of Conduct and supporting policies, standards and procedures, including compliant management of Budget, Safety, Health and Environment.A typical day in the role would include;

  • Leading/supporting the delivery of diagnostic testing to clinical studies as agreed with project leaders including: diagnostic test establishment in partner laboratories, monitor diagnostic test data for quality control, provide scientific troubleshooting when necessary and preparation of study reports with presentation at appropriate meetings.
  • Leading/supporting the delivery of diagnostic data work packages to enable regulatory submission and approval inclusive of studies to enable market adoption and life cycle management.
  • Managing projects across internal and external partners in a global multi-disciplinary environment, applying scientific, technical and operational expertise. Identify opportunities, propose solutions and work across boundaries in the scientific area(s) of expertise that will enable drug development projects and diagnostics labelling.
  • Building and maintaining a knowledge of current and emerging diagnostic assay technologies in area of expertise.
  • Driving continuous improvement in the scientific area(s) of expertise, aligned to Precision Medicine strategic objectives of increasing project success, adding value to projects and delivering better medicines to patients.
  • Being accountable for the time and quality of agreed deliverables.
  • Providing updates on the progress, risks and opportunities of the agreed deliverables to the appropriate governance bodies for review, challenge and issue resolution.
  • Taking on small supervisory or skills transfer / training roles.
  • Monitoring and ensuring compliance with all AstraZeneca Policies and Standards, and local law/regulation, and immediately address instances of non-compliance.
    • Essential skills and experience
  • Scientist: BSc / Masters; Senior Scientist: Masters / PhD or equivalent experience in a relevant subject
  • Knowledge of tissue-based biomarker assays, such as immunohistochemistry (IHC) and/or in situ hybridisation (ISH), including troubleshooting and QC
  • Operational experience of clinical trial set up, documentation and monitoring
  • Excellent knowledge of scientific literature with deep understanding in diagnostic related area demonstrated through publications in peer reviewed journals
  • Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, Good Clinical Practice and Quality Systems Regulation)
  • Experience of tissue test quality control, test data monitoring and troubleshooting
  • Experience of effectively working across internal and external boundaries
  • Ability to communicate with stakeholders for study updates, testing progress through oral presentations and progress reports
  • Ability to identify risks and escalate appropriately
  • Good interpersonal skills and ability to act as an ambassador for Precision Medicine internally and externally
    • Desirable skills and experience
  • An understanding of drug and companion diagnostic assay co-development and commercialisation and experience working in early and late phase projects
  • Demonstrable experience of analytical diagnostic assay validation and use in a clinical testing setting.
  • Experience of delivery and use of data for diagnostic projects for regulatory submissions
  • Experience of working with diagnostic partners to drive timely and successful outcomes
  • Experience of leading projects within a diagnostic or drug development organisation
  • Understanding of related areas e.g. drug-diagnostic co-development, partnering and commercialisation
  • Data management and statistical analysis (experience in one of the following: R, SPSS, SAS, Minitab, GraphPad Prism)
  • Experience of data visualisation tools (E.g. Spotfire)
    • Competitive remuneration and company benefits applyLocation: Chesterford Research Park, UK or Warsaw, PolandClosing Date: 15th May 2020Next Steps, if you are interested in the role please apply!AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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