Senior Analyst Method Development

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

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.
* 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 & 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

Qualifications

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