Method Development Expert

Permanent East Midlands Jobs & Advice in Medical/Pharmaceutical/Scientific
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Job Description

Analytical Method Development Expert

An exciting and unique opportunity has come up for an analytical method development scientist to join a growing CDMO at their site in the Midlands. Joining the R&D team, you will be working as part of a team responsible for the testing and development of new inhalation pharmaceutical products as part of a successful R&D organisation.

Main Responsibilities

The Analytical Method Development Chemist is responsible for leading the development of analytical methods that will be used for the testing of pharmaceutical products. This will include developing methods 'from scratch' which will have marginal or zero literature available. The principal dosage form will be inhalation, and the main technique will be LC. The successful candidate should have a knowledge of organic chemistry, in order to facilitate full contribution to the development of stability indicating impurity methods.

Knowledge & Skills

Ideally the successful candidate will have extensive experience working in analytical method development and method validation, with particular emphasis on development of HPLC methods.

This experience will ideally be gained as the main focus of your role. Additional desirable experience includes:

* Knowledge of organic chemistry and experience of relating this knowledge to the prediction of degradation pathways of organic molecules is preferred.

* 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, with experience of inhalation products preferred

* Experience of a wide range of instrumental analysis 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 is preferred, 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

Overall this is a great opportunity for an experienced method development specialist to use their wealth of knowledge in an R&D setting, and expand current knowledge and skills.

If this sounds like the opportunity for you, please apply with your CV now

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