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 pre-clinical analytical studies and clinical studies in compliance with the Study Plan/Amendments, GLPs, SOPs, and current industry best practices;
- Interpret, analyze, document, and report of results on Analytical projects (validation and sample analysis);
- Co-ordinate results with various Clients, consultants and Toxicology Study Directors;
- Produce reports and ensure that any deviations be accepted, including their impact on the data of the study;
- Respond to QA comments and questions on each phase of study;
- Keep up to date with regulatory developments in the industry;
- Write, review and apply all relevant SOPs.
- Bachelor of Science B.Sc. (Chemistry, Biochemistry or related field).
- A minimum of 10 years of 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 regulations associated;
- Experience and knowledge of the analytical instrumentations (LC-MS / MS, GC-MS);
- Knowledge of regulatory agency guidelines (OECD, FDA);
- A strong team player with excellent communication skills;
- Skilled in interpretation of data and report writing;
- Written and oral comprehension in both English and French.
Fields marked with an asterisk (*) are required.