Head, Quality Control and Analytical Development

We are seeking a Head, Quality Control & Analytical Development to join Aspect's technical operations team to lead and scale our quality function spanning Analytical Development, Quality Control, and Biomarker development and testing, and analytical support of research programs. Reporting to the SVP, Technical Operations, the Head of Quality Control and Analytical Development will be responsible for building a comprehensive, phase-appropriate quality function to support the development and manufacturing of our bioprinted tissue therapeutics.

**Responsibilities**
- Own and oversee the full scope of Analytics, QC Analytics, QC Microbiology, and Analytical development, Biomarker development, and research analytical support.
- Build and lead a high-performing team across multiple disciplines, embedding a culture of compliance, science-driven decision making, and continuous improvement.
- Lead the Analytical Development and QC Analytics function responsible for developing, qualifying, and executing methods to support product characterization, release, and stability testing for cell therapy and combination therapy programs.
- Design, implement, and maintain the SOPs, ensuring compliance with applicable regulatory requirements (e.g., GTP, GxP, GMP FDA, Health Canada, EMA, ISO14385).
- Oversee QC testing programs, including environmental and microbiological monitoring, release testing, and stability.
- Ensure compliance with applicable regulatory requirements (e.g., GxP, Health Canada, FDA, EMA) as the company scales toward IND-enabling and clinical-stage activities.
- Establish and maintain rigorous quality oversight for nonclinical and analytical processes, ensuring the validity, reliability, integrity, and traceability of analytical data.
- Collaborate cross-functionally with Process Development, R&D, Regulatory, and Operations teams to embed a quality culture and robust analytical processes throughout the product lifecycle.
- Oversee the qualification of assay methods and ensure documentation is robust.
- Serve as the senior Analytical representative in interactions with health authorities, partners, and external auditors, and contribute quality expertise to regulatory submissions (e.g., IND, CTA) through the authoring and review of relevant sections and documentation.

**Who You Are**
- **Education & Experience**: Bachelor's, Master's, or PhD in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences) and10+ years of quality experience, with leadership roles in Analytical development and QC, preferably in cell/gene therapy, including at least 3 years in a leadership role overseeing analytical quality functions. Experience in combination products is preferred.
- **Regulatory Knowledge**: Deep understanding of GxP principles (GLP, GMP, GCP) and regulatory expectations in North America and EU, with specific expertise in analytical testing requirements for biologics and/or cell therapies; experience supporting IND/CTA filings and inspections with a focus on analytical data and method validation.
- **Cell Therapy Experience**: Direct experience with quality oversight of analytical methods used for advanced therapies (e.g., autologous/allogeneic cell therapy, tissue engineering, or regenerative medicine), including potency assays, identity tests, and characterization methods, is strongly preferred.
- **Analytical Quality Systems**: Proven track record of building or implementing quality systems with a strong emphasis on analytical method validation, stability programs, reference standards, data integrity, and QC laboratory operations in early-stage biotech or clinical-phase organizations.
- **Strategic Thinker**:You bring a forward-looking mindset and can anticipate analytical needs as the organization moves toward the clinic.
- **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.

**Who We Are**

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

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