We are seeking an enthusiastic Senior Associate, QC Analytics to join our Quality Control team. You will play a key role in the Chemistry, Manufacturing, and Controls (CMC) department, ensuring the seamless transition of biomaterials from research and development into manufacturing for our bioprinted therapeutics. The contributions made in this position will have a profound impact on the future of healthcare by enabling the creation of bioprinted tissues that have the potential to revolutionize the treatment of currently incurable diseases.
Responsibilities
- Perform routine and non-routine analytical testing for raw materials, in-process samples, and finished products, ensuring compliance with established SOPs and regulatory guidelines (e.g., GTP, GxP, GMP).
- Assist in the development, qualification, and transfer of analytical methods to support product characterization, release, and stability testing for cell therapy and combination therapy programs.
- Accurately record, analyze, and interpret analytical data. Prepare clear and concise documentation, including test reports, summaries, and method development protocols.
- Strictly follow and maintain Standard Operating Procedures (SOPs) related to analytical testing, equipment operation, and data management.
- Participate in laboratory investigations, out-of-specification (OOS) results, and out-of-trend (OOT) incidents, assisting in root cause analysis and corrective actions.
- Perform routine maintenance, calibration, and qualification activities for QC analytical equipment.
- Work closely with the Analytical Development, Process Development, R&D, and Manufacturing teams to ensure seamless analytical support throughout the product lifecycle.
- Identify opportunities for process improvements within QC analytics to enhance efficiency, accuracy, and compliance.
- Contribute to the preparation of relevant sections for regulatory submissions (e.g., IND, CTA) by providing accurate analytical data and documentation support.
Qualifications & Experience
- Education: Bachelor’s or Master’s in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences) plus 3-5+ years of quality experience, in Analytical development and QC, preferably in cell/gene therapy.
- Regulatory Knowledge: Deep understanding of GxP principles (GLP, GMP, GCP) and regulatory expectations in North America and EU, with experience in analytical testing requirements for biologics and/or cell therapies.
- Analytical Quality Systems: Experience with quality systems supporting analytical method validation, stability programs, reference standards, data integrity, and QC laboratory operations in early-stage biotech or clinical-phase organizations.
- Audit & Compliance: Experience with audits (internal, vendor, regulatory) with a focus on analytical laboratories and data, and quality risk management specifically related to analytical methods and testing.
- Collaborative Partner: You thrive in cross-functional environments and know how to balance compliance with innovation.
- Quality Champion: You take pride in fostering a strong quality culture and embedding it into every stage of product development.
- 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 $61,000 - $87,000, 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!
Top Skills
Aspect Biosystems Vancouver, British Columbia, CAN Office
Vancouver, British Columbia, Canada
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