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Analytical Method Development Lead - Loughborough
I am currently looking for a new Analytical Method Development Expert to join the R and 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.
*Work as part of a team responsible for the testing and development of new inhalation pharmaceutical products as part of a successful R and D organisation.
*You will be responsible for leading the development of analytical methods that will be used for the testing of pharmaceutical products.
*Supporting the testing of drug products with '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.
*Work with clients and on new development projects on drug development.
*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 and Compulsory requirements
*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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