Director, Drug-Device Platform & Development

AbCellera Biologics Inc.; Vancouver; On-site; CAD 200,000 - 250,000; Full time

Benefits offered by this job

Equity

Annual bonus

RRSP contribution 6%

Active Lifestyle Allowance CAD 1,500

Health benefits

Professional development

Job summary

AbCellera Biologics Inc. is seeking a Director, Combination Products & Device Development to drive device strategy across combination product programs, including pre-filled syringes and autoinjectors.

You will lead a cross-functional team of engineers and oversee DHF, HF, and regulatory docs to ensure compliant, scalable delivery. This role demands deep industry experience with a proven track record in bringing drug-device combinations from development to commercial launch, with strong

Qualifications

• Bachelor’s or post-graduate degree in mechanical, biomedical, or chemical engineering, and at least 15 years of hands‑on device engineering experience
• Proven track record in developing and commercializing drug‑device combination products
• Deep expertise in design controls and quality system requirements for combination products

Responsibilities

• Lead design, development, verification, validation, transfer, and commercialization of drug-device combination products
• Oversee design control activities and Design History File (DHF) deliverables per global regulatory standards
• Mentor and lead engineers, fostering scientific excellence and cross-functional collaboration
• Oversee Human Factors strategies, including IFU development and HF studies
• Lead device-related risk management and due diligence for tech transfers and scale-up
• Manage external partners/CDMOs to meet technical, timeline, and budget objectives
• Own drug-device interface alignment across input requirements, EDDOs, and packaging
• Guide packaging, shipping, and distribution strategies for prefilled syringes and autoinjectors
• Collaborate with Quality, Regulatory, Manufacturing, and Supply Chain to maintain QMS and supplier controls
• Provide regulatory documentation content for IND/CTA/BLA/MAA submissions

Skills

Device engineering

Leadership

Design controls

FDA regulations

Quality systems

Prefilled syringes

Autoinjectors

External partners

Human Factors

Cross-functional comms

Education

Engineering degree (Mechanical/Biomedical/Chemical)

Job description

AbCellera Biologics Inc. is seeking a Director, Combination Products & Device Development to drive device strategy across combination product programs, including pre-filled syringes and autoinjectors.

You will lead a cross-functional team of engineers and oversee DHF, HF, and regulatory docs to ensure compliant, scalable delivery. This role demands deep industry experience with a proven track record in bringing drug-device combinations from development to commercial launch, with strong