Analyste Bioanalytique

Under medium supervision, the analyst performs analyses of drugs and their metabolites in biological samples using various extraction methods (liquid/liquid, SPE, etc.) while following standard operating procedures (SOPs) and Good Laboratory Practice (GLP).Responsibilities & duties: Regulated Bioanalysis : Independently perform quantitative analyses of drug molecules in biological matrices for pharmacokinetic, bioequivalence and bioavailability studies.Method Validation : Assist in method development and validation of LC/MS/MS bioanalytical methods for protein precipitation, liquid-liquid extraction and solid-phase extraction. Under supervision, prepare validation worksheets and plans.Data processing : Have a basic understanding of integration parameters and know when and how to reinject samples or reintegrate sample chromatograms.Data reporting : Ability to compile data.Instrumentation : Can set up and run routine operations independently, including becoming familiar with basic HPLC and MS troubleshooting procedures. Operate the Hamilton robot for simple studies such as a simple two-way crossover or preclinical analysis.Training : complete all specified training modules for sample extraction and cleaning, optimization of liquid chromatography and mass spectrometry conditions, data review and report writingDocument preparation : Review and revise BioLab SOPs and forms as required Skills, knowledge & aptitudes : Knowledge of computer systems (MS Office)Knowledge of GLP & GMPKnowledge of required laboratory instruments (HPLC, LCMS, Mass Spectroscopy)Understanding of laboratory documentation requirements (Different types of extractions : protein precipitation, liquid-liquid extraction, solid-phase extraction)