Director, CMC Quality
AbCellera
AbCellera seeks an experienced Director of CMC Quality to lead quality strategy and compliance for antibody products from clinical development through commercialization. The role requires deep technical expertise in cGMP regulations, product control strategies, and cross-functional collaboration to ensure regulatory compliance and product lifecycle continuity.
Responsibilities
- Serve as senior Quality leader on CMC core team communicating strategy, risks, and changes
- Lead CMC product Quality sub-team defining strategy and deliverables across product lifecycle
- Implement phase-appropriate control strategies for specifications, testing, and comparability
- Maintain Product Quality Risk Register identifying and escalating manufacturing and supply chain issues
- Provide regulatory expertise for clinical and commercial submissions and health authority inspections
Requirements
- Bachelor's degree in Life Sciences or Engineering; Master's or PhD preferred
- 12+ years biopharmaceutical experience in Quality, Regulatory, or Manufacturing Compliance
- CMC development and commercialization experience with prefilled syringes and autoinjectors
- Deep understanding of global cGMP regulations and phase-appropriate requirements
- Expertise in product and process control and comparability strategy design
- Strong leadership capability with cross-functional stakeholder management skills
Vacancy posted 4 days ago
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