Director, Combination Products & Device Development
AbCellera · Vancouver
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
AbCellera seeks a Director of Combination Products & Device Development to lead the design, development, and commercialization of drug-device platforms including prefilled syringes and autoinjectors. This role bridges hardware engineering and biology, overseeing design control frameworks, regulatory compliance, and supplier partnerships to deliver antibody therapies to patients.
What they're looking for
- Bachelor's degree or higher in mechanical, biomedical, or chemical engineering or related field
- Extensive experience developing combination products, prefilled syringes, or autoinjector systems
- Expertise in design control, Design History Files, and global regulatory requirements
- Proven leadership managing cross-functional teams and external partners including CDMOs and suppliers
- Knowledge of human factors validation, risk management, and quality management systems
- Experience with device-drug interface integration and manufacturing scale-up
What you'll be doing
- Architect and oversee design control framework and DHF deliverables for combination product programs
- Lead cross-functional teams and external partners through development, transfer, and commercialization phases
- Manage human factors strategies, instructions for use development, and regulatory documentation
- Own device-drug interface alignment, including container closure systems and manufacturing capabilities
- Drive quality management systems, supplier controls, and governance processes across combination products
Privacy & handoff
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