Process Engineer II (Cryopreservation)

We are seeking a Process Engineer II, Cryopreservation to join our dynamic Technical Operations team. In this pivotal role, you will support the development and optimization of packaging processes, with a focus on developing cryopreservation strategies and executing stability, packaging, and shipping studies to ensure the integrity and viability of our drug product (DP) across all stages of operation. The majority of your time will be spent in the lab, driving hands-on experimentation and analysis to refine and validate processes. Your contributions will be critical in advancing healthcare, driving the development of BTTs that have the potential to revolutionize the treatment of diseases. 

Responsibilities 

• Collaborate with R&D and Analytics Development to design, execute, and develop cryopreservation protocols, including selection of cryoprotectant procedures, that preserve the integrity, function, and viability of our DP. 
• Design, execute, and interpret experiments to optimize freezing, thawing, and storage conditions for our BTT, ensuring maximum viability and potency of cells.
• Design and execute studies to assess stability under cryogenic conditions. 
• Design, execute, and interpret stability studies on the shelf-life of the DP in compliance with ICH guidelines.
• Conduct forced degradation studies to support formulation development. 
• Develop shipping and packaging protocols ensuring container closure systems maintain integrity throughout shelf-life and shipping. 
• Conduct risk assessments and failure mode analyses to identify and mitigate potential issues in packaging and shipping.
• Assist in sourcing,  evaluating, and qualifying  packaging materials and services in collaboration with external vendors ensuring alignment  with Aspect’s quality standards and adherence to ICH guidelines.
• Conduct packaging compatibility, extractables/leachables, and shipping simulation studies as needed.
• Work closely with R&D, Quality Assurance and Manufacturing teams to align packaging processes with overall product development and commercialization goals.
• Prepare and maintain thorough documentation of experimental designs, standard operating procedures, technical protocols, and reports in compliance with regulatory requirements (Annex 1 and ISO13485 standards)
• Support technology transfer activities to manufacturing sites, ensuring robustness and reproducibility of packaging and stability protocols.
• Contribute to preparation of relevant sections for regulatory submissions (e.g., IND)  by developing and providing documentation  that adheres to regulatory  guidelines. 
• Analyze scientific data to identify trends, drive improvements, and support decision-making.

Qualifications & Experience                                                                    

• Education + Experience:  A Master’s or Bachelor’s degree in Biomedical Engineering, Materials Science, or a related field, and 7-9 years of industry experience. 
• Technical Expertise: Strong foundation in packaging process development, preferably in the cell therapy or biologics space. Experience with cryopreservation protocols, formulation stability testing, and shipping logistics.
• GMP & GDP Knowledge: Working knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). 
• Early-Stage Regulatory Understanding: Demonstrated understanding of the requirements for early-stage regulatory filings ( e.g., IND), particularly as they related to process development and CMC sections. 
• Mission-Driven: You are passionate about enabling the development of life-changing therapies and driving high standards to support patient safety and product excellence.
• Thrive in Ambiguity: You are highly adaptable, agile, and poised when faced
  with change, ambiguity and competing priorities.
• Go-Getter: You work with a sense of urgency, are results-driven, and thrive in a fast-paced, interdisciplinary and entrepreneurial environment. You are willing to roll up your sleeves and do what it takes to get the job done.

The hiring range for this role is $103,000 - $147,000 CAD, 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.

Aspect Biosystems is a Canadian biotechnology company creating bioprinted tissue therapeutics to transform how we treat disease. Our bold team of innovators and entrepreneurs have joined us from all over the globe to create a new class of regenerative medicine and work towards a future where our bioprinted tissues are used to save lives and make people healthier. We are endlessly curious and wildly passionate about what we do. Every person on our team is a key contributor to our success and is eager to roll up their sleeves to make a difference in the ever-changing world of biotech. If you are committed to making a real impact and accelerating the development of life-changing therapies, we want to hear from you!

Curious about our current perks and benefits? Learn more here.

At Aspect Biosystems, our strength has always been in our diversity. Different people, thinking differently, unified in creating a world that is better for us all. We are committed to creating an inclusive environment for everyone on our team. All aspects of employment — including the decision to hire, promote, discipline, or terminate — are based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, colour, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, provincial, or local law.

If you're interested in joining our team but don't see a job posting that matches your experience or background, we encourage you to submit a general application to be considered for future opportunities!