Abcellera
Director, Pharmaceutical Delivery
Overview
We are looking for a Director, Pharmaceutical Delivery to become a key technical driver for device development across our combination product programs, including pre-filled syringes and autoinjectors. In this role, you’ll architect our design control framework and lead strategic supplier partnerships that turn design intent into manufactured reality.
About Abcellera
Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.
Requirements & Eligibility
- Bachelor’s or post-graduate degree in mechanical, biomedical, or chemical engineering, or a related field
- At least 12 years of meaningful, hands-on experience in device engineering
- Proven track record of advancing combination products, including prefilled syringes with safety devices, and autoinjectors, from clinical development through commercial approval
- Deep expertise in design controls and quality system requirements for combination products, with extensive experience applying FDA regulations and international standards
Key Responsibilities
- Providing strategic leadership for the design, development, verification, validation, transfer, and commercialization of drug-device combination products including prefilled syringe and autoinjector platforms
- Owning and overseeing combination product development strategies, design control activities, and Design History File (DHF) deliverables
- Leading cross-functional internal subject matter experts and external partners to advance development of combination products through commercial launch
- Providing oversight of Human Factors (HF) strategies and activities, including instructions for use (IFU) development
- Leading device-related risk management, technical due diligence, and gap assessments to de-risk technology transfers and scale-up efforts
- Driving external technical partnerships, holding CDMOs, suppliers, and consultants accountable to technical, quality, timeline, and budget objectives
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