Scientist, Analytical Development

We are seeking a Scientist, Analytical Development to join our dynamic and diverse Quality Control team. In this role, you will use your experience and expertise to support and execute studies for the development, qualification, and validation of analytical assays to assess in-process samples and finished products. 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

• Execute routine and non-routine analytical testing for cell/gene and combination products using standard techniques such as ELISA, multi-colour flow cytometry, qPCR, fluorescent microscopy, and other analytics as needed.
• Participate in development and qualification of analytical assays (g., viability, identity, potency, and purity) following regulatory guidance (e.g., ICH, FDA, ISO) and transfer of analytical methods into and out of QC Analytics.
• Support the design and execution experimental protocols, author experimental reports, and present data summaries to stakeholders.
• Maintain analytical databases and analyze complex data sets using statistical tools, ensuring accuracy, integrity, and compliance.
• Work with the Aspect’s Process Development, Manufacturing, R&D, and Engineering teams to generate, optimize, and characterize analytical assays to support internal pipeline and regulatory development.
• Create and maintain Standard Operating Procedures (SOPs), batch records, and other documentation as required in compliance with Good Documentation Practices (GDP).
• Participate in laboratory investigations, out-of-specification (OOS) results, and out-of-trend (OOT) incidents, assisting in root cause analysis and corrective actions.
• Ensure all testing activities meet regulatory (e.g., FDA, EMA) and internal quality standards. Identify opportunities for continuous improvement of QC processes and systems 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 Experience: A Masters or Doctorate in a relevant scientific discipline (e.g., Biology, Cell Biology, Experimental Medicine, Biotechnology, or related discipline) plus 4-6 years of quality experience, in Analytical Development and/or Quality Control, preferably in cell/gene therapy. Experience in assay qualification/validation is considered an asset.
• 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, 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.
• Effective Communicator: You are an active listener who can communicate to different audiences in diverse situations.
• Critical Thinker: You excel at evaluating difficult challenges, seeking input from different sources, and contributing to well-informed decisions.

The hiring range for this role is $87,000 - $97,000, 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!