Scientist- Analytical Department – Bioanalysis

4 weeks ago


Baied'Urfé, Canada ITR Laboratories Canada Inc. Full time

At ITR Laboratories Canada INC

Our Mission is to bring new medicines to the world which relieve patients suffering from serious diseases.

ITR Laboratories Canada has been servicing the pharmaceutical and biotechnology industries for over 30 years and has established itself as a trusted partner worldwide in Drug Safety Testing. We are actively seeking a Scientist- Analytical Department – Bioanalysis (LC-MS/MS) to join our team as we continue to expand our reach and services.

Responsibilities:

The Scientist will be responsible for developing Bioanalytical LC-MS/MS assays. They will write new standard operation procedures (SOP’s) and update current SOP’s 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.

Tasks Performed:

  • Research and development for LC-MS/MS assays including troubleshooting ongoing 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.

Education/Qualifications :

 

  • Bachelor of Science B.Sc. (Chemistry, Biochemistry or related field).

 

Experience

 

  • Experience of project management in a CRO environment.
  • Excellent understanding of bioanalytical analysis and the associated regulations.
  • Experience and knowledge of analytical instrumentation (LC-MS/MS).
  • Passion for regulatory agency guidance (OECD, FDA, ICH).
    A strong team player with excellent oral and written communication skills.
  • Skilled in data interpretation and report writing.
  • Bilingual English and French

 

 

This position offers:

  • Permanent full-time position, 
  • Group insurance plan and group RRSP.
  • A stimulating and friendly work environment.

Start Date: ASAP  

 



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