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Scientist- Analytical Department- Analytical Chemistry

May 5 2017
Industries Pharmaceutical, Biotechnology
Categories Chemistry
Baie-d'Urfe, QC

Scientist- Analytical Department- Analytical Chemistry

Primary Responsibilities:

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.

Tasks Performed:

  • 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 network