You will love this role if you have a passion for science and medicine, you thrive in a fast-paced environment and enjoy contributing to drug development in an integrated communicative team environment.
The Analytical Development Scientist will be responsible for the planning / development / implementation / optimization of assays necessary for assessing protein characteristics. The incumbent will participate in the assessment of the quality of manufactured lots using platform tests and support R&D activities. Additional responsibilities will be to plan and execute the pre-validation of developed assays using defined scientific and regulatory practices required for assay transfer to QC laboratories. An important part of the role will be to structure data analysis, perform the trending of data, and to write and/or review analytical documentation (analytical development reports, analytical methods, work instructions for the use of laboratory equipment, etc.). The incumbent will also organize and execute the development of appropriate formulations to ensure stability and suitability for clinical administration of a drug product.
This is a full-time position that reports to the Associate Director, Analytical Development and is based in Montreal.
Duties and Responsibilities:
- Design the development or implementation of analytical assays for protein-based compounds.
- Lead the development of robust analytical procedures adapted to manufactured proteins assay panel.
- Use scientific knowledge and field established best practices in use for product analytical characterization.
- Provide scientific support and guidance during assay development and product characterization.
- Participate in the assay transfer, qualification or validation as per ICH guideline to QC laboratories.
- Perform structured data analysis, trending and basic statistics.
- Generate internal protocols, reports and procedures.
- At a minimum a graduate level (M.Sc.) in biochemistry, biotechnology, life sciences or equivalent.
- At least 3 years of experience in analytical development or relevant experience in the biopharmaceutical or biotechnology industry.
- Experienced in protein chemistry and related analytical methods.
- Hands on experience with HPLC and/or Capillary Electrophoresis (CE), Dynamic Light Scattering (DLS) and/or immunological techniques (ELISA).
- Experienced in experimental planning, problem solving and troubleshooting.
- Demonstrated structured analytical thinking, precision and attention to details.
- Ability to execute experiments independently and efficiently.
- Ability to work in cross-functional teams and in a fast-paced environment.
- Experience of the current Good Manufacturing Practices (cGMP) is an asset.
- Excellent verbal and written communication, written and spoken.
Key words: Biochemistry, Protein Analyses, Assay Development, HPLC, Capillary Electrophoresis, ELISA, DLS