Associate Scientist, Formulation Development
$64,000–$80,000 year
On-siteVancouver, British Columbia, Canada
Job Summary
Conduct pre-formulation and formulation development studies for antibody-based drug products, including buffer preparation, sample handling, and testing. Perform forced degradation, thermal, freeze-thaw, agitation, and photostability studies to assess formulation robustness. Draft standard operating procedures, work instructions, and study protocols. Design, execute, and monitor stability studies, compiling and trending data while supporting investigations of atypical results. Support small-scale fill-finish activities, including fill volume determination, filtration, and mixing studies. Conduct biophysical and analytical characterization using methods such as SEC, IEX CE-SDS, DSC, and DLS. Compile data into reports and communicate technical results to diverse audiences. Maintain accurate records in electronic lab notebooks in accordance with Good Documentation Practices. Perform routine laboratory operations, including instrument qualification, calibration, and inventory management.
Required Qualifications
- equivalent of 2+ years of industry experience
- Bachelor's or Master's degree
- experience with protein formulation, stability, and biophysical characterization for liquid or lyophilized drug products
- strong understanding of how process parameters, equipment, raw materials, scale, site differences, and process-related stresses can impact product quality
- familiar with various analytical techniques for characterizing biopharmaceuticals (e.g., liquid chromatography, capillary electrophoresis, and/or spectroscopy-based methods)
- working knowledge of electronic lab notebooks (e.g., Benchling), and with 21 CFR Part 11 compliance requirements
- strong organizational, data management, and time management skills, with excellent attention to detail
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