Senior Bioanalytical Laboratory Specialist

4 days ago


Toronto, Canada Novum Pharmaceutical Research Services Full time
Job Summary

We are seeking a highly skilled and experienced Laboratory Analyst to join our team at Novum Pharmaceutical Research Services. The successful candidate will be responsible for performing extraction of drugs/metabolites from bio-study samples, developing and validating bio-analytical methods, and operating laboratory equipment in accordance with GCP/GLP and OECD Series on Principles of Good Laboratory Practice.

Responsibilities:

  • Perform extraction and bioanalysis of drugs and metabolites from biological samples in bio studies using LC-MS/MS, by established procedures and in compliance with GCP, GLP, OECD Series on Principles of Good Laboratory Practice, SOP, and regulatory guidelines
  • Develop and validate bio-analytical methods under GCP/GLP and SOP guidelines using LC-MS/MS
  • Operate calibrated laboratory instrumentation such as LC-MS/MS, HPLC, UPLC, UHPLC, LHS, balances, evaporators, centrifuges, etc. in accordance with SOP specifications.
  • Perform calibration of laboratory instrumentation such as LC-MS/MS, HPLC, UPLC, UHPLC, LHS, pH meters, pipettes, etc.
  • Perform development and validation of specific laboratory documentation (e.g. laboratory logbooks/ worksheets, analytical data, project notes/forms/memos) for assigned projects and regulatory submissions and in compliance with the Principles of Good Laboratory Practice and responsible for the quality of the data.
  • Assist Research scientists in performing root cause analysis and corrective action when experiment failure occurs.
  • Preparation of Method SOPs, system SOPs, and instrument SOPs.
  • Identify and report instrumental, analytical, health, and safety issues.
  • Notify department management regarding omissions, incomplete results, or other irregularities.
  • Documents and communicate any deviations from the instructions directly to the immediate Supervisor and/or if appropriate, the Principal investigator.
  • Maintain training records, documenting training entries promptly.
  • Work in a safe manner that does not endanger yourself and coworkers.
  • Flexible to work in shifts, necessary to ensure completion of assigned tasks.
  • Archival of Bioanalytical data.
  • Responsibilities regarding the conduct of GCP/GLP and Non-GLP studies In addition to General Responsibilities, the following are additional responsibilities regarding the conduct of GCP/GLP and Non-GLP studies: Attachment 1 SOP NOV/QA/0001-1
  • Generate analytical test results in compliance with all current SOPs, protocols, study plans, and applicable GLP (OECD), EMA, ICH, FDA, and TPD requirements.
  • Document and communicate any deviations to these instructions directly to the Principal Investigator (for GLP studies) or Study Director (for Non-GLP studies).
  • Record raw data promptly and accurately and in compliance with the OECD Principles of Good Laboratory Practice.
  • Exercise health precautions to minimize risk and to ensure the integrity of the study.
  • Communicate to the Laboratory Management any relevant known health or medical condition so he/she can be excluded from operations that may affect the study

Qualifications:

  • Has completed a Bachelor of Science or college program in analytical chemistry, or pharmaceutical sciences with chemistry laboratory exposure.
  • 2-5 years experience in the Pharmaceutical industry is required.
  • Knowledge of extraction procedures, bioanalytical method validation, instrument calibration, and spreadsheet software.
  • Excellent analytical skills are essential.
  • Word processing is essential.
  • Strong organizational skills.
  • Good interpersonal skills.
  • This position requires effective written and oral communication in the English language.
  • Excellent report writing skills.
  • Must be flexible and effective in the completion of tasks. Ability to retain and apply technical data and to source out required technical information of moderate complexity.


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