The Senior Scientist will be responsible for developing the careers of all staff members within the Bioanalytical group and supporting the development of the Bioanalytical business. They will write new SOP's and update current SOP's, including those applicable to GC-MS, and to current GLP regulatory requirements. In addition, they will be acting as Study Director or Analytical Principal Investigator for designated preclinical or clinical studies in a CRO environment. Analytical data integrity, on time reporting, and meeting project budgets are all critical aspect of supporting client project goals.
Research and develop for LC-MS/MS and GC-MS assays.
Conduct analytical pre-clinical and clinical studies in compliance with the Study Plan/Amendments, GLPs, SOPs, and current industry best practices.
Interpretation, analysis, documentation, and reporting of results on Analytical projects (validation and sample analysis).
Co-ordinate results with various Clients, consultants and Toxicology Study Directors.
Generate reports, or reporting of results, within study timelines, and ensure any deviations/exception events are acceptable, including their impact on study data.
Respond to QA comments on each phase of a study.
Keep up to date with respect to pertinent regulatory developments in the industry
Write, review and apply all relevant SOPs
Design system and software validations
Internal: Between departments, Toxicology Study Directors, QA, or as required
External: Clients, Consultants
A minimum of 10 Years Scientific experience of project management in a CRO environment
Passion for Bioanalytical Chemistry and instrumentation in a preclinical CRO environment.
Excellent understanding of bioanalytical analysis and the associated regulations
Experience and knowledge of analytical instrumentation (LC-MS/MS, GC-MS)
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