Analytical Early Chemical Development Scientist

Analytical Early Chemical Development Scientist

Eurofins

Macclesfield, United Kingdom

The purpose of this job is to support analysis of pharmaceutical raw materials, intermediates and drug substance with accurate results within an acceptable timeframe.

Job Responsibilities:

• To perform routine and non-routine Analytical Testing using a broad range of analytical techniques for RSM, Intermediates and Drug Substance at early phase development including LC, IC, GC, MS, ICP and spectroscopic methodology;
• Testing support to DSM;
• Stability Study Testing Support;
• Reference Standard Requalification support;
• Method Development and Method Validation experience would be desirable;
• Synthetic Chemistry support small scale;
• To review analytical data for GMP compliance;
• To prepare and approve results for tests in which they have received the appropriate training and are deemed competent;
• To train as required, other Eurofins or Client employees in analytical techniques and electronic system in which the Analyst is competent;
• To initiate and follow-up OOS results and action limits as per customer procedures;
• 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;
• 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:

• A degree in Chemistry or a related discipline is required;
• Proven relevant experience of pharmaceutical analysis in a development laboratory, or equivalent, is desired;
• Experienced and competent with traditional analytical techniques as well as modern instrumental equipment (HPLC, IC, GC Karl Fischer, Mass Spectroscopy, ICP and other Spectroscopic techniques). Able to interpret raw data and draw conclusions regarding troubleshooting of instruments and methods;
• Experience working with oligonucleotides and peptides would be desirable;
• Thorough understanding of chromatographic techniques with some trouble shooting capabilities;
• Thorough understanding of requirements for working in a GMP environment;
• Ability to quickly learn new processes. Works proactively to offer suggestions for new ways to improve existing processes;
• Ability to work on own initiative and be capable of developing solutions to problems as part of a team;
• Good communication skills both internally and externally. Must be able to communicate documents or concepts to co-workers or clients independently;
• Thorough understanding of requirements for working in a GMP environment;
• Ability to work using fully electronic media, including MS Office;
• Ability to form strong working relationships with colleagues;
• Good team player, organised, accurate, have strong documentation skills;
• Passionate about quality and customer service.