Principal Analytical Scientist

Proclinical are in search of a motivated experienced analytical chemist to join a Drug Substance and Product Analysis teams in England. As a member of a team you will lead analytical aspects aligned to the development, manufacture and supply of new small molecule drug substances.

Job Responsibilities

• Lead the transfer of methods to commercial manufacturing sites
• Author sections of regulatory submissions and develop responses to regulatory questions
• Contribute to the development of the analytical control strategy for new drug substances
• Executing analytical work safely in accordance with GMP
• Apply analytical techniques including; HPLC, GC, KF and spectroscopic techniques which will cover projects right across the development cycle from first time in human through to commercialisation
• Working in a matrix team to ensure appropriate analytical methods are in place as required for the assessment of intermediates and drug substance and their release for clinical use
• Clearly report the results of your experiments and communicate the results and your

Skills and Requirements

• BSc/MChem (or equivalent) in a relevant discipline
• Previous experience of analytical techniques including; HPLC, GC, KF and spectroscopic techniques
• Knowledge of ICH quality guidelines and their applicability to small molecule drug substance
• GMP knowledge / experience
• Knowledge of the requirement for releasing drug substances for clinical studies

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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