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Analytical Method Development Expert - Oferta z Jobs.pl

Badania i Rozwój » Specjalista ds. badań i rozwoju

  • Województwozagranica
  • Miejscowośćinne
  • AdresUnited Kingdom
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Analytical Method Development Expert

Nr ref.: /JOBS.pl

  • Salary: 40000.00-47000.00 British Pound . GBP (Annual)


    I am currently looking for a new Analytical Method Development Expert to join the R&D team of my client's global healthcare organisation, specialising in Inhalation, based in Loughborough.

    Working Hours -37.5 hours per week, Monday - Friday on a permanent basis, with a competitive salary and benefits.

    Overall Mission

    *Work as part of a team responsible for the testing and development of new inhalation pharmaceutical products as part of a successful R&D organisation.
    *You will be responsible for leading the development of analytical methods that will be used for the testing of pharmaceutical products.
    *This will include 'from scratch' methods which will have marginal or zero literature available.
    *The principal dosage form will be inhalation, and the main technique will be LC. T
    *The successful candidate will also be required to have a knowledge of organic chemistry, in order to facilitate full contribution to the development of stability indicating impurity methods.

    Knowledge & Skills required;

    *Very knowledgeable in the theoretical aspects of analytical method development with particular emphasis on development of LC methods
    *Practical experience of the execution of method development and method validation
    *Knowledge of organic chemistry and experience of relating this knowledge to the prediction of degradation pathways of organic molecules.
    *Experienced in the validation requirements for analytical methodology in the pharmaceutical industry (MHRA/FDA/ICH etc.)
    *Experienced in working to GMP (good manufacturing practice)
    *A track record of problem solving and production of robust methodologies to analyse pharmaceutical products.
    *Experience of a wide range of instrumental as well as practical experience of "wet" and classical chemistry.
    *Proven ability to work methodically and pay meticulous attention to detail.
    *Experienced in the characterisation of organic impurities, with emphasis on utilising LC with mass spectrometry detection as the principal means of elucidation
    *Broad knowledge of current industry practices, with an established network of relevant external contacts, ideally having history of authoring relevant publications
    *Working knowledge of analytical method life cycle management, to include Quality by Design and method risk assessments


    *Degree qualified, MSc or PhD in Chemistry and/or Biochemistry
    *Extensive experience in a method development role in the pharmaceutical industry.


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