Director, CMC Quality - Antibody Therapeutics

Peptide Atlas; Vancouver; Vor Ort; CAD 180.000 - 220.000; Vollzeit

Benefits dieser Stelle

Equity

Annual bonus

RRSP contribution

Active Lifestyle Allowance

Health benefits

Professional development

Vacation

Zusammenfassung

AbCellera is seeking an experienced Director, CMC Quality to act as a technical quality expert for antibody products from clinical development through post-commercialization. You will lead quality decisions, manage risks, and partner across teams to ensure product quality and regulatory compliance.

You will set quality strategy, oversee change control and product comparability, and support regulatory submissions with subject matter expertise.

Qualifikationen

• Bachelor’s degree in Life Sciences or Engineering; MS/PhD preferred.
• 12+ years of biopharmaceutical experience in Quality, Regulatory, or Manufacturing Compliance.
• CMC development and commercialization experience across antibody products.

Aufgaben

• Serve as senior Quality leader on the CMC core team and communicate quality strategy, deliverables, risks, and changes.
• Lead the CMC product Quality sub-team to define strategy and deliverables across the product lifecycle.
• Execute product strategy with quality and scientific rigor aligned to development, tech transfers, and regulatory filing strategies.
• Implement phase-appropriate control strategies for materials, drug substance, and drug product specifications and controls.
• Maintain Product Quality Risk Register and escalate quality/compliance risks as needed.
• Interpret and apply global regulatory guidelines (Health Canada, FDA, EMA, ICH) to product quality.
• Assess changes and deviations for quality impact and develop implementation plans.
• Contribute quality expertise to clinical and regulatory submissions and inspections.

Kenntnisse

CMC Quality leadership

Regulatory compliance

Cross-functional leadership

Quality risk management

Global regulatory filing

Ausbildung

Bachelor’s degree in Life Sciences or Engineering

MS or PhD preferred

Jobbeschreibung

AbCellera is seeking an experienced Director, CMC Quality to act as a technical quality expert for antibody products from clinical development through post-commercialization. You will lead quality decisions, manage risks, and partner across teams to ensure product quality and regulatory compliance.

You will set quality strategy, oversee change control and product comparability, and support regulatory submissions with subject matter expertise.