Director, Combination Products & Device Development

AbCellera

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.

Responsibilities

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

Requirements

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

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Vacancy posted 18 days ago

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