Scientist- Analytical Department- Analytical Chemistry
The Scientist is responsible for acting as Study Director for Validation Studies and Analytical Principal Investigator for designated preclinical or clinical studies in a CRO environment. They will ensure the overall integrity of all Analytical data with respect to GLPs and appropriate regulatory requirements.
Research and develop high performance liquid chromatography – UV, Fluorescence or ELSD detection methods for a variety of different dose or inhalation samples
Responsible for Analytical preclinical or clinical validation projects. Conduct studies in compliance with the Study Plan/Amendments, GLPs, SOPs, and current industry best practices.
Serve as the single point of contact in the Analytical Department for Toxicology Study Directors with respect to their Toxicology Studies.Perform the sample analysis and co-ordinate results with the Toxicology Study Director.
Review and provide comments and recommendations for the Analytical portions of preclinical Toxicology Study Plans
Generate reports, or reporting of results, within study timelines, and ensure any deviations/exception events are acceptable, including their impact on study data.
Interpretation, analysis, documentation, and reporting of results on Analytical projects (validation and sample analysis).
Respond to QA comments on each phase of a study.
Communicate Analytical data with various Clients, consultants and Toxicology Study Directors.
Keep up to date with respect to pertinent regulatory developments in the industry
To meet client timelines for all Analytical analysis and reporting
Review and apply current/revised SOPs
To perform other duties as required
Internal: Between departments, Toxicology Study Directors, QA, or as required
External: Clients, Consultants
Bachelor of Science B.Sc. (Chemistry, Biochemistry or related field).
3 Years Scientific experience of project management
Passion for Analytical Chemistry in a preclinical CRO environment.
Experience and knowledge of analytical instrumentation (eg – HPLC-UV, Fluorescence, ELSD)
Interest in regulatory agency guidelines (OECD, FDA).
A strong team player with excellent oral and written communication skills.
Skilled in data interpretation and report writing.
Excellent interpersonal skills.
Bilingual English and French