Our client, a global company providing biological, non-clinical, clinical and bioanalytical assay solutions to pharmaceutical and biotechnology companies, is currently seeking a Validation Analyst/Specialist.
Nature of position
Under the supervision of the Director of Operations, your main mandate will be to rigorously follow standard operating procedures (SOP) and good laboratory practices (GLP). As a manager, you will carry out various regulated analyzes of drugs and metabolites for production studies and for method validation by LC-MS/MS. In case of problem areas, you consult your immediate supervisor, propose appropriate action plans and make informed decisions to ensure efficient and compliant operations. As such you will see to:
- Perform the regulated analysis of drugs and metabolites in biological samples (extraction methods) for production studies and method validation by LC-MS/MS, in accordance with Good Laboratory Practices (GLP), regulations of the United States Food and Drug Administration (21 CFR Part 58), and principles of the OECD;
- Complete relevant forms related to sample analysis and document all steps performed;
- Analyze results by verifying chromatography and concentration data obtained;
- Assist the immediate supervisor in resolving analytical problems and generating data;
- Report any equipment or material issues to the immediate supervisor to ensure timely repair or replacement of equipment;
- Document all required information or deviations in a timely manner and in accordance with GLP and SOP (information sheet, deviation);
- Interact with R&D staff on ongoing validations and report any issues (system issues, extraction problems, etc.);
- Perform any other tasks related to the position.
- University degree or college diploma in biochemistry, chemistry, or any other relevant field;
- Minimum of 5 years of relevant experience in bioanalysis, including a minimum of 2 years of method validation;
- Knowledge of GLP regulations;
- Understanding of various extraction procedures (SPE, liquid-liquid, protein precipitation, derivatization);
- Relevant experience in bioanalysis (HPLC and mass spectrometry);
- Proficiency in both French and English, both orally and in writing;
- Ability to work independently and prioritize tasks;
- Ability to work efficiently to ensure projects are completed within the specified deadlines.
Salary and condition
Salary and conditions according to company policy and candidate experience.
The location shown on the map is approximate and is included for information purposes only.