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Assay Development Lead

Marketplace Group
Job LocationNewcastle Upon Tyne
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Leading Medical Devices organisation requires an Assay Development Lead, skilled in cutting edge scientific techniques and someone who can take a product from defined requirements to commercial launch.You will be responsible for leading Assay Development and deliver a portfolio of IVD assays for commercialisation on the platform. The assay technologies include sample processing methods, pathogen concentration methods, DNA/RNA extraction, multiplexed PCR and qPCR assay design and development, and end-point PCR assay design and development.Key Roles & Responsibilities

  • A key success factor for this position is the ability to work in a fast paced, cross functional group environment, with a focus on delivery of objectives to timelines, and a willingness to be involved across a wide area of responsibilities.
  • The jobholder will be responsible for leading all aspects of IVD assay design and development.
  • Lead and develop an extensive assay design and development team
  • Continuously identify and implement process improvements
  • Manage and track the Assay Development spend including OPEX and CAPEX making appropriate decisions to minimise expenditure while delivering on business-critical goals
  • Develop IP, keeps abreast of competitor patents and technologies and support the patent process including drafting and reviewing claims
  • Work with the Systems Integration team and Project Management team to identify plans, resources and schedules as well as both project and individual tasks
  • Apply a breadth of knowledge to both directly solve problems and guide the team through structured problem solving. Identify technical risks and proactively implement mitigation strategies and plans
  • Transfer assays to manufacturing and quality control and provide product lifecycle support (as required)
  • Build relationships and projects with external evaluation partners and laboratories to gather assay performance and utility data
  • Plan, lead and manage validation activities in line with IVD regulatory requirements
    • Skills and experience:
  • Hold a Ph.D. or have equivalent experience in Molecular Biology or a related discipline
  • Have in depth knowledge of DNA and RNA amplification techniques, detection technologies, sample processing technologies, molecular assay design and infectious diseases.
  • Be experienced in taking a product from defined requirements through to commercial launch
  • Have a track record of publishing and presenting the outcome of assay design and development activities
  • Be experienced in assay performance evaluation and regulatory submissions
  • Be skilled in cutting edge scientific techniques and their application to rigorous and ethical scientific research, maintaining confidentiality at all times
  • Adhere at all times to the legislation, guideline and demands of the external and internal regulatory environments including working to ISO13485 and ISO14971
  • Manage working practices within Cat 3 laboratories
  • Be experienced in point-of-care diagnostics and lab-on-a-chip microfluidics devices
  • Have experience working with multiple sample matrices including blood, plasma, urine, saliva, etc.
  • Have previous experience working with STIs, HPV, TB and respiratory assays
  • Bring knowledge of statistics and advanced data presentation
  • Be experienced in bioinformatics and NGS
    • Required skills
  • Assay Development
  • ISO13485

    • Keyskills :
    Assay Development ISO13485

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