Senior​/Staff Engineer, Pharmaceutical Delivery

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.

We are looking for a Senior/Staff Engineer, 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. You’ll work closely with Quality, Regulatory, Formulation, and Drug Product teams, sitting at the intersection of hardware engineering and biology, ultimately shaping how our antibody therapies reach patients and become clinical reality.

• Steering delivery device strategy and technical execution across our growing portfolio of drug-device combination programs
• Leading Design History File creation from the ground up, translating user needs into ironclad product specs, design controls, and trace matrices
• Developing AbCellera’s Human Factors (HF) program from formative studies through summative validation, and authoring the Instructions for Use, device labelling content, and the HF engineering report
• Conducting gap analysis assessments to de-risk scale up and confirm that each fill and assembly site can meet the device-critical attributes defined in the Device Input Requirements
• Driving external technical partnerships, holding CDMOs, suppliers, and consultants to high standards while actively optimizing work packages and project scope
• Owning the drug-device interface; seamlessly translating formulation and container closure attributes into precise device design inputs, while aligning Process Development teams on drug product constraints
• Leading packaging and shipping evaluation designs for Prefilled Syringes and Autoinjectors to guarantee product integrity through distribution
• Partnering with Quality Assurance to review, author, and maintain medical device/combination product QMS SOPs and align Quality Agreements with suppliers
• Integrating human factors strategies, design reviews, and design freeze milestones into broader CMC project timelines prior to clinical assembly
• Supporting regulatory strategies and authoring device-related sections for clinical submission packages (IND/CTA)

• You bring meaningful, hands-on experience in device engineering - from mechanical, biomedical, or chemical engineering, or another related field that’s given you real depth in developing pharmaceutical delivery devices. We’re looking at roughly 8+ years of experience (6+ with a Master’s) for the Senior level, and 12+ years (10+ with a Master’s) for Staff, where you’ve built the depth to take on a more senior scope
• You have direct experience in drug delivery systems and combination products (prefilled syringes, autoinjectors, or safety systems preferred), though strong medical device experience with parenteral drug delivery exposure will be considered
• You possess a solid working knowledge of FDA Design Controls (21 CFR 820.30, 21 CFR Part
  4) and relevant standards (ISO 13485, ISO 11608, ISO
  11040, ISO 14971, IEC 62366)
• You have direct experience managing external device partners/CDMOs, with the technical authority to scrutinize scope and hold vendors accountable
• You are familiar with Human Factors Engineering principles and integrating user research into formal device design controls
• You have experience with distribution and transport simulation studies for parenteral presentation types
• You possess excellent cross-functional communication skills, strong attention to detail, and a collaborative mindset suited for a fast-paced biotech environment

AbCellera’s hiring range for the Senior Engineer role is CAD $116,000 - $145,000 annually and the range for the Staff Engineer role is CAD $140,000 - $174,600 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, an annual…