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Analyste Expert, bioanalytique

Analyste Expert, bioanalytique

PharmascienceMontréal, QC, CA
20 days ago
Job type
  • Full-time
Job description

The Expert Bioanalytical Analyst performs impurity confirmation tests in pharmaceutical products and elemental analyses in biological samples using various extraction methods (liquid / liquid, SPE, etc.) and ensures that SOPs, good laboratory practices, and good manufacturing practices are followed. Additionally, demonstrates leadership within the laboratory.

Duties and Responsibilities :

  • Sample Analysis : Perform quantitative analysis of elements in biological matrices for non-clinical and clinical studies and confirmatory testing of impurities in medicines and pharmaceutical product as per GMP requirements.
  • Validation : Perform validation of LC / MS / MS and ICP-MS analytical methods. Assist in method development when needed. With supervision prepare validation worksheets and validation plans.
  • Data Processing : Have a basic understanding of integration parameters and when and how to reinject samples or reintegrate samples chromatograms.
  • Data Reporting : Ability to compile data.
  • Instrumentation : Can setup and start routine runs independently, including familiarity with HPLC, ICP and MS basic troubleshooting procedures.
  • Training : Complete all training modules specified for samples extraction and clean up; optimization of HPLC-MS / MS and ICP-MS conditions; data review and report writing.
  • Document Preparation : Review and revise SOPs as assigned.
  • Participates in the investigation and CAPA process.

Skills, Knowledge and Abilities :

  • Knowledge of Good Laboratory Practices and Good Manufacturing Practices
  • Technical knowledge of instrumental testing such as HPLC-MS / MS, ICP-MS
  • Technical knowledge of protein precipitation; liquid-liquid extraction and solid phase extraction
  • Good knowledge of method validation guidelines
  • Any experience in other types of analytical techniques would be an asset.
  • Attitude for teamwork.
  • Practical knowledge of computers and laboratory data analysis programs.
  • Work experience in the pharmaceutical industry.