The Analytical Development Research Associate role will participate in the development and troubleshooting of assays necessary for assessing protein characteristics and the quality of manufactured lots. This role will also participate in the routine execution of developed assays and the maintenance of laboratory equipment. The incumbent will also use defined scientific practices in the development of appropriate formulations to ensure stability and suitability for clinical administration of a drug product. Additional responsibilities will be to participate in the pre-validation of developed assays using defined scientific and regulatory practices required for assay transfer to QC laboratories, to participate in the trending of data, and the writing and/or review of analytical documentation (analytical development reports, analytical methods, work instructions for the use of laboratory equipment, etc.).
This is a full-time position that reports to the Analytical Development Manager and is based in Montreal.
Duties and Responsibilities:
- Analyze recombinant protein candidates produced from a mammalian cell line system platform using typical assays for protein characterization (e.g.: HPLC, CE, SDS-PAGE, DLS, ELISA, cell-based assays)
- Participate in the development of protein formulation chemistry and the execution of required analyses.
- Participate in the development of analytical assays on lead recombinant proteins for R&D purposes as well as for transfer to quality control laboratories.
- Responsible for experimental data analysis and proper documentation (electronic lab notebook and records).
- Generate protocols and reports on performed experiments.
- Responsible for laboratory equipment maintenance.
- Provide technical/scientific support during analytical development.
- Participate in technology transfer activities.
- Minimum Undergraduate degree (B.Sc.) in biochemistry, biotechnology, life sciences or equivalent.
- At least 2 years of experience in the performance of analyses for the development of recombinant proteins or relevant experience in the biotechnology or biopharmaceutical industry.
- Experienced with HPLC and/or Capillary Electrophoresis (CE), Dynamic Light Scattering (DLS) and immunological techniques (ELISA).
- Precision, attention to detail and team spirit.
- Knowledge of analytical technologies for proteins.
- Ability to execute experiments independently.
- Ability to work in cross-functional teams and in a fast-paced environment.
- Experience in problem solving and troubleshooting.
- Knowledge of the current Good Manufacturing Practices (cGMP) is an asset.
- Good verbal and written communication skills in French and English.
Key words: Biochemistry, recombinant proteins, protein analyses, HPLC, Capillary Electrophoresis, ELISA, DLS