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Salary: CAD 90,000 - 96,300 / annual
Aspect Biosystems is seeking a Scientist, Analytical Development to join the technical operations team, reporting to the Head of Quality Control and Analytical Development. You will be instrumental in developing, optimizing, and qualifying analytical methods that support the company's cutting-edge bioprinted tissue therapeutics platform.
Key responsibilities include:
• Design, execute, and optimize a variety of analytical methods (cell-based assays, bioanalytical and flow cytometry methods) for characterization, release, and stability testing of raw materials, in-process samples, and final drug products.
• Participate in and execute experiments for qualification and validation of analytical methods in accordance with phase-appropriate regulatory guidelines (ICH, FDA, Health Canada, EMA).
• Perform routine analytical testing 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.
• Adhere to and contribute to the development of robust analytical quality systems, ensuring data integrity, traceability, and regulatory compliance.
Aspect Biosystems is a biotechnology company pioneering regenerative medicine using a full-stack tissue therapeutic platform that integrates proprietary AI-powered bioprinting technology, therapeutic cells, hypoimmune cell engineering, and advanced biomaterials. The company is advancing its therapeutic pipeline across multiple endocrine and metabolic diseases, including diabetes and rare endocrine disorders.
QUALIFICATIONS & REQUIREMENTS:
• Education: Bachelor's or Master's degree in a relevant scientific discipline.
• Experience: 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 understanding of regulatory expectations for analytical method development, qualification, and validation for biologics or advanced therapies.
• Problem-Solving: Keen eye for detail and methodical approach to troubleshooting analytical challenges.
• Innovation Mindset: Eager to learn new techniques and contribute to continuous improvement of analytical processes.
