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Job summary

The role involves steering delivery device strategy for drug-device combination programs and architecting design control frameworks. You will lead strategic supplier partnerships and ensure device development meets regulatory and quality standards from design intent to clinical reality.

Job details

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. How you might spend your days 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) We’d love to hear from you if 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, ISO11040, 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 What we offer 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 bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution. You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship are a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials. About AbCellera Creating medicines is the most important work we can do. We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline. Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications. We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience. We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines. To apply Please submit your application through our website and refer to Job ID 23388 in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.

What you’ll do

The role involves steering delivery device strategy for drug-device combination programs and architecting design control frameworks. You will lead strategic supplier partnerships and ensure device development meets regulatory and quality standards from design intent to clinical reality.

Requirements

Candidates must have 8-12+ years of experience in device engineering, specifically with parenteral drug delivery systems like autoinjectors or prefilled syringes. A strong working knowledge of FDA design controls and relevant ISO standards is required.

Benefits

• Equity • Annual bonus • RRSP contribution • Active lifestyle allowance • Annual vacation • Professional development • Health benefits

Listed skills

• Quality assurance · Preferred
• Project management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Device engineering
• Combination products
• Design controls
• Human factors engineering
• Mechanical engineering
• Biomedical engineering
• Chemical engineering
• FDA regulations
• ISO 13485
• ISO 14971
• IEC 62366
• CDMO management
• Design history file
• Regulatory strategy
• Quality assurance
• Project management
• Technical Authority
• Courage
• Human Factors Engineering
• Combination Products
• Project Scoping
• Parenteral Drugs
• Human Factors
• User Research
• Medical Devices
• Title 21 Of The Code Of Federal Regulations
• Quality Management Systems
• Biotechnology
• Biology
• Chemical Engineering
• Pre-Clinical Development
• Immunology
• Communication
• Computer Engineering
• Distributed Control Systems
• Endocrinology
• Packaging And Labeling
• Gap Analysis
• ISO 14971 Standard
• ISO 13485 Standard
• Oncology
• Mentorship
• Milestones (Project Management)
• Pharmaceuticals
• Process Development
• Quality Assurance
• Control Framework
• Tenacity
• Timelines
• Detail Oriented

Job areas

• Engineering
• Healthcare
• Science & Research
• Technology
• Pharmaceutical Engineer
• Mechanical Engineer (General)
• Mechanical Engineers