Analytical Chemical Development Scientist
Eurofins
Macclesfield, United Kingdom
The purpose of this role is to provide Analytical support to the client’s drug substance development area from late phase clinical through to commercial development support.
Job Responsibilities:
- To perform routine and non-routine Analytical Testing using a broad range of analytical techniques for Regulatory starting materials, Intermediates and Drug Substance including LC, GC, MS, and spectroscopic methodology;
- Support the development and subsequent validation of LC and GC analytical methodology;
- Support any relevant technical troubleshooting activities;
- Ensure work activities are conducted to the highest standards of quality and GMP compliance;
- To identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement;
- To document data as dictated by current client policies and procedures;
- Operate in electronic systems including electronic notebooks and chromatographic data systems;
- To ensure that all documentation is carried out on time, is accurate and legible and conforms to the relevant quality standards;
- To update any relevant documentation when requested by Lead Scientist or client representative.
- To participate in the preparation of reports.
Qualifications:
- Degree in Chemistry or analytical chemistry is essential;
- A sound, fundamental knowledge of Chemistry is essential with an emphasis on organic chemistry and analytical science;
- Knowledge and experience within a pharmaceutical development environment and an understanding of the drug development process would be desirable;
- Method development experience is required;
- Method validation experience ideal;
- Knowledge and experience of drug substance and API analysis;
- Knowledge and experience of modern analytical techniques such as HPLC and GC within a development environment is essential;
- At least 4 years’ relevant experience of pharmaceutical analysis in a development laboratory;
- Experience of additional techniques such as NMR and LC-MS would be an advantage;
- Proven ability to troubleshoot issues relating to instrumentation and analysis as required;
- Good understanding of requirements for working in a GMP environment.
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