Senior Bioanalytical Chemist – Development and Validation of LC-MS/MS Assays

2 weeks ago

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

ITR Laboratories Canada Inc is a trusted partner in Drug Safety Testing, serving the pharmaceutical and biotechnology industries for over 30 years.

We are committed to bringing new medicines to the world which relieve patients suffering from serious diseases.

Job Description

The Scientist will be responsible for developing and validating bioanalytical LC-MS/MS assays. They will write new standard operation procedures (SOPs) and update current SOPs to current GLP regulatory requirements.

In addition, they will act as Study Director or Analytical Principal Investigator for designated preclinical or clinical studies in a CRO environment.

Key responsibilities include:

  • 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).
  • Coordinate results with various Clients, Consultants, and Toxicology Study Directors.
  • Generate reports 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.
  • Stay up-to-date with respect to pertinent regulatory developments in the industry.
  • Write, review, and apply all relevant SOPs.
Required Skills and Qualifications

To be successful in this role, you will need:

  • Bachelor of Science degree in Chemistry, Biochemistry, or related field.
  • Experience of project management in a CRO environment.
  • Excellent understanding of bioanalytical analysis and 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.
  • Data interpretation and report writing skills.
  • Bilingual English and French.
Benefits

This position offers:

  • Permanent full-time position.
  • Group insurance plan.
  • Group RRSP.

A stimulating and friendly work environment.

Estimated Salary Range

$80,000 - $110,000 per year, depending on experience.

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