We're looking for a highly motivated Senior Process Engineer to take on an important role in our dynamic and dedicated Process Development team. Reporting to the Head of Process Development, you will work on developing an aseptic manufacturing workflow for our bioprinted tissue therapeutics. You’ll be joining a company committed to developing regenerative medicines that deliver life-changing, functional cures for patients living with serious diseases. 

Responsibilities 

• Leading the conceptualization, design, implementation and characterization of complex fluidic systems, bioreactor scaling strategies, and automated cell processing workflows (wash, concentrate, harvest) to reduce process risk and improve robustness.
• Working with Process Development, Bioengineering, Engineering and Manufacturing to ensure seamless technical integration of the cell therapy process into the final device platform, focusing on closed-system design and single-use technologies.
• Leading process risk assessments (e.g., FMEA, PHA) for both the cell manufacturing process and its interaction with the medical device component.
• Developing mathematical models and implementing approaches such as DOE (Design of Experiments) to help define critical process parameters (CPPs) and critical quality attributes (CQAs).
• Supporting technology transfer to Manufacturing including support for process qualification as well as assisting in early phase clinical manufacturing as needed.
• Providing technical support for troubleshooting and participating in out-of specification and root cause analysis during manufacturing deviations or process improvements.
• Working with our Quality team to define the validation strategies for sterilization, biocompatibility, and extractables/leachables (E&L) as well as providing the technical backbone for regulatory filings (CTA/IND).
• Identifying gaps in current cell therapy manufacturing and developing patentable technologies to improve yield, purity, and scalability.
• While an individual contributor role, you will mentor others and foster a culture of technical excellence and rigorous data-driven decision-making.

Qualifications & Experience

• Education + Experience: M.S. or Ph.D. in Chemical Engineering, Bioengineering, Biomedical Engineering, or a related life science field with 6-8+ years of relevant industry experience, in cell therapy, bioprocess development, or biologics manufacturing.
• Knowledge: Strong hands-on background in the development, characterization, and optimization of biomanufacturing processes is required, preferably within cell therapy. 
• You have expertise in the design, implementation, and characterization of complex fluidic systems, including automated cell processing workflows (e.g., wash, concentrate, harvest). Proven ability to develop mathematical models and apply statistical methods (such as Design of Experiments, or DOE) for process characterization and defining Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). Experience with bioreactor systems and scaling strategies is desirable.
• You have thorough knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Familiarity with regulatory requirements for cell therapy products (e.g., providing technical content for CTA/IND filings).
• You have strong analytical, problem-solving, and data-driven decision-making skills. Excellent written and verbal communication skills, including the ability to present complex data and mentor junior team members.
• You thrive in a multi-disciplinary team environment and believe that we can get further, faster by working together.
• You are an active listener who can effectively communicate to different audiences in diverse situations. 

The hiring range for this role is $124,737 -  $131,689 CAD annually. Our ranges are based on market data. 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. Note that base salary is just one part of the overall compensation at Aspect. Members of the Aspect team also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.

We're looking for a Scientist, Analytical Development to join Aspect's 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 a 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.

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.
• Problem-Solver: You have a keen eye for detail and a methodical approach to troubleshooting analytical challenges.
• Innovation Mindset: You're eager to learn new techniques and contribute to the continuous improvement of analytical processes.

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.

Thank you for your interest in joining Aspect Biosystems! This job posting serves as a general application for candidates who are eager to explore opportunities with our company. By submitting your application here, you're expressing your interest in potential future roles with Aspect Biosystems.

We're always on the lookout for talented individuals who share our passion for innovation and are excited about the possibility of contributing to our mission to transform the treatment of disease with bioprinted tissue therapeutics. While there may not be specific openings available at the moment, we encourage you to submit your application so we can keep your information on file for future opportunities that align with your skills and experience.

Please note that submitting your application through this posting does not guarantee immediate consideration for a specific position. However, it allows us to review your profile and reach out to you when relevant opportunities arise.

Thank you again for considering Aspect Biosystems as a potential employer. We look forward to reviewing your application and potentially welcoming you to our team in the future!