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Scientist, Analytical Development
Aspect Biosystems
Vancouver, CAN
Full-time
Mid · 3+ years experience
Onsite
CAD 90000-96300 yearly / year
Discovered Yesterday
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Responsibilities
- Design, execute, and optimize a variety of analytical methods (e.g. cell-based assays, bioanalytical and flow cytometry methods) for the characterization, release, and stability testing of raw materials, in-process samples, and final drug products.
- Participate in and execute experiments for the qualification and validation of analytical methods in accordance with phase-appropriate regulatory guidelines (e.g., ICH, FDA, Health Canada, EMA).
- Perform routine analytical testing as needed to support process development, product characterization, and early-stage stability studies.
- Accurately record, analyze, interpret, and present experimental data. Author and review technical reports, study protocols, and standard operating procedures (SOPs) in compliance with GxP principles.
- Identify and troubleshoot analytical method issues, propose solutions, and implement corrective actions.
- Work cross functionally with Process Development, Quality Control, Research & Development, and Manufacturing to support product development milestones and resolve analytical challenges.
- Perform routine maintenance and calibration of analytical instruments and ensure proper functioning.
- Adhere to and contribute to the development of robust analytical quality systems, ensuring data integrity, traceability, and compliance with internal and external regulations.
Qualifications & Experience
- Education & Experience: Bachelor's or Master's degree in a relevant scientific discipline with 3-5 years of relevant experience in analytical development within the biotechnology or pharmaceutical industry with hands-on experience in cell therapy, gene therapy, or combination products.
- Analytical Expertise: Proven hands-on experience with a range of analytical techniques, such as flow cytometry, ELISA, and/or cell-based assays.
- GxP Knowledge: Familiarity with GxP principles (GLP, GMP) and an understanding of regulatory expectations for analytical method development, qualification, and validation for biologics or advanced therapies.
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