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