Process Engineer I (Bioprinting CMC)

We're seeking a highly motivated Process Engineer I to join our high-performing Bioprinting CMC team. In this pivotal role, you will be instrumental in developing, characterizing the drug product (DP), and refining the manufacturing processes for our groundbreaking tissue therapeutics, driving them from early-stage development through to IND (Investigational New Drug) submission and beyond. Your contributions will be critical in advancing healthcare by establishing the foundational manufacturing processes for therapeutics with the potential to revolutionize the treatment of diseases previously deemed incurable.

Responsibilities

• Design and execute experiments to develop and optimize manufacturing processes for production of DP. 
• Design and conduct experiments to identify critical process parameters (CPP) and critical quality attributes (CQA).
• Collaborate extensively with Aspect’s Technical Operations, Research and Development, and Engineering teams to innovate, optimize, and translate laboratory -scale bioprinting processed to scalable manufacturing operations. 
• Assisting with the technology transfer of processes to different manufacturing sites. 
• Establish and perform rigorous testing and validation protocols for DP to ensure they meet predefined specifications for structure, function, and biological activity.
• Provide technical support for troubleshooting and participate in out-of specification and root cause analysis during manufacturing deviations or process improvements.
• Ensure the preparation of materials and reagents for DP processes adheres to Good Documentation Practices (GDP).
• Lead the development, characterization, and validation of bioprinting to meet project-specific and company-wide milestones.
• Ensure that optimization and scaling strategies for DP production align with current Good Manufacturing Practices (cGMP) regulations.
• Contribute to preparation of relevant sections for regulatory submissions (e.g., IND)  by developing and providing documentation  that adheres to regulatory  guidelines. 
• Developing protocol and processes that aligns with Annex1 and ISO13485 standards.

Qualifications & Experience

• Education + Experience: A Master’s or Bachelor’s degree in Biomedical Engineering, Materials Science, or a related field, and 5-7 years of industry experience. 
• Process Development & Characterization Experience: Strong hands-on background in the development, characterization, and optimization of biomanufacturing processes in a cGMP setting, ideally within cell or tissue therapy.
• Analytical Techniques & Proficiency: Skilled in various analytical techniques relevant to process and product characterization, including but not limited to mechanical testing, microscopy, and other relevant assays. Expertise in statistical process control methodologies and Design of Experiments (DOE) for process optimization and analysis is essential.
• GMP & GDP Knowledge: Thorough 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 relate 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.

The hiring range for this role is $77,000 - $110,000 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!