Director, CMC Quality

The role

The Director, CMC Quality serves as a technical quality expert for antibody products from clinical development through post-commercialization. You will provide quality leadership and act as the single point of contact for technical decisions, risks, and activities for assigned products.

What you will do

• Serve as the senior Quality leader on the CMC core team to communicate product Quality strategy, deliverables, risks, and changes
• Lead the CMC product Quality sub-team to define product quality strategy, priorities, and deliverables
• Execute product strategy using quality and scientific knowledge aligned with CMC development and regulatory filing strategies
• Implement phase-appropriate control strategies for starting materials, drug substance, drug product, and stability
• Maintain the Product Quality Risk Register to identify, mitigate, and escalate issues
• Monitor and review cross-functional processes and product data to identify trends and quality risks
• Interpret and apply regulatory guidelines such as 21CFR, EU GMP, USP, Ph. Eur., and ICH
• Assess changes, deviations, and other events for product quality impact
• Provide Quality expertise for clinical and commercial regulatory submissions and health authority inspections

Required qualifications

• Bachelor’s degree in Life Sciences or Engineering (e.g., Biology, Biochemistry, Chemical Engineering)
• 12+ years of biopharmaceutical experience in Quality, Regulatory, or Manufacturing Compliance
• Experience includes CMC development and commercialization of products such as pre-filled syringes and autoinjectors
• Deep understanding of global cGMP regulations (Health Canada FDA, EMA, ICH)
• Demonstrated expertise in designing and executing product & process control and comparability strategies
• Excellent interpersonal and communications skills
• Demonstrated strong leadership capability
• Detailed-oriented and highly organized

Nice to have

• MS or PhD
• Prior CMC Quality leadership experience

Benefits

• Equity
• Annual bonus dependent on team and company performance
• 6% (non-match) RRSP contribution
• CAD $1,500 annual Active Lifestyle Allowance
• Annual vacation
• Professional development opportunities
• Comprehensive health benefits
• Scientific and technical mentorship

Before you apply

• Please submit your application through our website and refer to Job ID 23421 in your cover letter
• We are only able to contact those who are selected for an interview

About the company

AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology.