Validation Analyst/Specialist (bioanalysis)

Our client, a global company providing bioassay, non-clinical, clinical and bioanalytical solutions to pharmaceutical and biotechnology companies, is currently seeking for a Validation Analyst/Specialist.

Nature of position

Under the supervision of the Director of Operations, your main mandate will be to perform various regulated analyses of drugs and metabolites for production studies and method validation by LC-MS/MS. As such, you will :

• Performs regulated analysis of drugs and metabolites in biological samples (extraction methods) for production studies and for method validation by LC-MS/MS in accordance with Good Laboratory Practice (BPL), U.S. Food and Drug Administration regulations (21 CFR Part 58) and OECD principles ;
• Assist in the preparation of reports ;
• Participate in problem solving related to bioanalytical methods as needed ;
• Ability to prioritize and organize multiple requests in a day ;
• Have good writing skills and a willingness to constantly learn in relation to therapeutic areas ;
• Write and review standard operating procedures (PON) ;
• Carry out every other task compatible with your functions.

Required qualification

• University degree or college diploma in biochemistry, chemistry or other relevant training ;
• Minimum of 3 years of relevant experience in bioanalysis (GLP knowledge is an asset) ;
• Knowledge of HPLC and mass spectrometers ;
• Knowledge of Microsoft Office, ThermoFisher Scientific Watson LIMS and Sciex Analyst software ;
• Ability to work independently and prioritize tasks ;
• Ability to work efficiently to ensure projects are completed on time.

Education / training

Bachelor in chemistry, D.C.S. - Analytical chemistry technic

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