We're looking for a highly motivated Process Engineer I to take on an important role in our dynamic and dedicated Process Development team. This is a chance to make a direct and lasting contribution to the manufacturing of our groundbreaking implantable cell therapy products. You will be instrumental in evolving our processes from early-stage development through to IND (Investigational New Drug) submission and clinical manufacturing.
Responsibilities
- Develop an aseptic manufacturing workflow for our bioprinted tissue products with phase appropriate controls for clinical manufacturing.
- Collaborate with Aspect’s Technical Operations, Research and Development, and Engineering teams to translate laboratory-scale bioprinting processes to scalable manufacturing operations.
- Prepare relevant sections of regulatory documents such as pre-IND and IND filings.
- Apply process development tools such as QbD, FMEA and Material risk assessments to prioritize activities.
- Design and conduct experiments to identify critical process parameters (CPP) and critical quality attributes (CQA).
- Ensure the preparation of materials and reagents adheres to Good Documentation Practices (GDP).
- Ensure that optimization and scaling strategies align with current Good Manufacturing Practices (cGMP) regulations including 21 CFR Parts 210 and 211 and EU Annex1.
- Assist with technology transfer to different manufacturing sites.
- Provide technical support for troubleshooting and participate in out-of specification and root cause analysis during manufacturing deviations or process improvements.
Qualifications
- 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.
- Early-Stage Regulatory Understanding: Experience in preparation of early-stage regulatory filings (e.g., IND), particularly as they relate to process development and CMC sections.
- Process Development & Characterization Experience: Strong hands-on background in the development, characterization, and optimization of biomanufacturing processes is required, preferrably within cell therapy.
- Experience in the design and specification of single use consumables for aseptic operation is desirable.
- Experience with cryopreservation process optimization is desirable.
- Experience with bioreactor operation and optimization is desirable.
- Experience with production and packaging of implantable medical devices is desirable.
- 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).
- 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!
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What We Do
Aspect Biosystems is a biotechnology company pioneering the development of bioprinted tissue therapeutics to transform how we treat currently incurable diseases. Aspect is creating these next generation cell therapies by applying its full-stack tissue therapeutic platform, which combines the company’s proprietary bioprinting technology, therapeutic cells, biomaterials, and computational design. Aspect’s bioprinted tissue therapeutics are designed to replace, repair, or supplement biological function inside the body with the aim of treating currently incurable diseases such as type 1 diabetes as well as genetic and acquired liver diseases.
