Scientist, Analytical Development

<p>We're looking for a <strong>Scientist, Analytical Development </strong>to join our technical operations team. In this role, you'll be instrumental in developing, optimizing, and qualifying analytical methods that support our cutting-edge bioprinted tissue therapeutics. Reporting to our Head, Quality Control and Analytical Development, you'll play a crucial part in ensuring the quality and characterization of our innovative products as we advance toward clinical development.</p> <p><strong>Responsibilities </strong></p> <ul> <li>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.</li> <li>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).</li> <li>Perform routine analytical testing as needed to support process development, product characterization, and early-stage stability studies.</li> <li>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.</li> <li>Identify and troubleshoot analytical method issues, propose solutions, and implement corrective actions.</li> <li>Work cross functionally with Process Development, Quality Control, Research & Development, and Manufacturing to support product development milestones and resolve analytical challenges.</li> <li>Perform routine maintenance and calibration of analytical instruments and ensure proper functioning.</li> <li>Adhere to and contribute to the development of robust analytical quality systems, ensuring data integrity, traceability, and compliance with internal and external regulations.</li> </ul> <p><strong>Qualifications & Experience</strong></p> <ul> <li><strong>Education & Experience:</strong> 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. </li> <li><strong>Analytical Expertise:</strong> Proven hands-on experience with a range of analytical techniques, such as flow cytometry, ELISA, and/or cell-based assays.</li> <li><strong>GxP Knowledge:</strong> Familiarity with GxP principles (GLP, GMP) and an understanding of regulatory expectations for analytical method development, qualification, and validation for biologics or advanced therapies.</li> <li><strong>Problem-Solver:</strong> You have a keen eye for detail and a methodical approach to troubleshooting analytical challenges.</li> <li><strong>Innovation Mindset:</strong> You're eager to learn new techniques and contribute to the continuous improvement of analytical processes.</li> </ul> <p>The hiring range for this role is $90,000 - $96,300, annually. Our pay scales are based on market data to ensure that compensation is competitive and fair. Offered salaries will be based on a combination of factors including, but not limited to, job-related knowledge, skills, education, and experience. For candidates who exceed role requirements, we are open to exploring above-range offers. Base salary is just one part of the overall compensation at Aspect, team members also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.</p> <p><br>&