Karen Mathews

Principal Scientist at Achilles Therapeutics plc
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Contact Information
us****@****om
(386) 825-5501
Location
Greater Cambridge Area, UK

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Experience

    • United Kingdom
    • Biotechnology Research
    • 100 - 200 Employee
    • Principal Scientist
      • Apr 2022 - Present

      Analytical Project Manager within Product Characterisation Analytical Project Manager within Product Characterisation

    • United Kingdom
    • Biotechnology Research
    • 1 - 100 Employee
    • Bioanalytical Laboratory Manager
      • Aug 2021 - Mar 2022

      Introduction of new procedures to ensure regulatory compliance (cGCLP). Oversight and technical input for internal and outsourced validation and sample analysis. Introduction of new procedures to ensure regulatory compliance (cGCLP). Oversight and technical input for internal and outsourced validation and sample analysis.

    • United Kingdom
    • Biotechnology Research
    • 700 & Above Employee
    • Analytical Project Manager/Senior Scientist - Large Molecule Bioanalysis
      • Aug 2015 - Aug 2021

      Project lead for method development, validation and application of bioanalytical methods including Biomarkers, qualitative and quantitative analysis of therapeutic drugs (PK) and immunogenicity (ADA) within a range of therapeutics and biological fluids. Organisation and running of projects, including ensuring timeline and regulatory adherence, resource planning and sponsor liaison. Technical writing of project plans, reviews and reports. Line management of scientists and day to day management of junior staff within my department. Familiarity with development and running of assays on a variety of platforms including ELISA, ECL (MSD), Luminex (Magpix) and AlphaLISA. Show less

    • France
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Technical Specialist - Analytical Development
      • Mar 2014 - Jul 2015

      Implementation and development of a body of work to characterize a biological product working to cGMP requirements. Working with project owners and technical experts to define requirements for work packages and select and develop assays to meet those requirements. Development and technical troubleshooting of assays using several methodologies including plate based assays, quantitative potency assays, molecular biology techniques and quantitation and analysis of product impurities.Responsibility for the day to day running of the project for method development. Provision of technical expertise along with progress data to the project leadership team and feedback of project requirements to my team to allow scheduling of work. Co-ordination of project related tasks with internal departments and external contractors. Providing direction and support to junior members of the team. Writing and review of technical documents. Show less

    • Technical Scientist - Analytical Development
      • Mar 2011 - Feb 2014

      Responsible for the selection, development, validation and troubleshooting of assays for a range of compounds including coagulation drugs and therapeutic toxins. Writing developmentand validation protocols, production of the associated reports and preparation ofstandard operating procedures (SOP’s). Performing technology transfer of the method as appropriate. Technical skills including plate based assays, coagulation assays, quantitative potency assays, impurity and product integrity testing. Show less

    • Senior Scientist
      • Jan 2010 - Dec 2010

      Development of in vitro assays for analysis and characterization of small molecule tissue and plasma kallikrein inhibitors. Testing and screening of the potential of compounds to inhibit enzyme activity. Design and development of assays including ELISA, Radioimmunoassay and coagulation assays. Use of Robotics (Biomek). Development of in vitro assays for analysis and characterization of small molecule tissue and plasma kallikrein inhibitors. Testing and screening of the potential of compounds to inhibit enzyme activity. Design and development of assays including ELISA, Radioimmunoassay and coagulation assays. Use of Robotics (Biomek).

Education

  • University of Liverpool
    Doctor of Philosophy (PhD), Pharmacology and Immunology
    2004 - 2009
  • University of Liverpool
    Bachelor of Science (BSc), Pharmacology
    2001 - 2004

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