Director, Combination Products & Device Development

AbCellera Biologics Inc.; United States; On-site; USD 140,000 - 176,000; Full time

Benefits offered by this job

Equity

Annual bonus

RRSP contribution

Active lifestyle allowance

Job summary

AbCellera Biologics Inc. is seeking a Director, Combination Products & Device Development to lead the device strategy for drug-device programs, including prefilled syringes and autoinjectors.

You will supervise DHF deliverables and ensure regulatory compliance across global markets. You will mentor a high-performing engineering team, drive Human Factors strategies, manage external partners, and align device inputs with drug product characteristics to deliver reliable Essential Drug Delivery

Qualifications

• Bachelor's or post-graduate degree in mechanical, biomedical, or chemical engineering.
• 15 years of hands-on device engineering experience.
• Experience with prefilled syringes and autoinjectors.

Responsibilities

• Provide strategic leadership for design, development, verification, validation, transfer, and commercialization of drug-device combinations.
• Oversee DHF deliverables and ensure regulatory compliance with global requirements and ISO standards.
• Lead and mentor a high-performing engineering team fostering collaboration and continuous improvement.
• Oversee Human Factors strategies and IFU development with regulatory documentation.
• Direct device-related risk management, due diligence, and technology transfer activities.

Skills

Device engineering

Team leadership

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s degree in engineering

Post-graduate degree

Job description

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 Director, Combination Products & Device Development 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 device platform strategy and oversee design controls to advance development of combination products through commercial launch. You’ll work closely with Clinical, Commercial, Quality, Regulatory, Formulation, and Drug Product teams, sitting at the intersection of hardware engineering and human experience, ultimately shaping how our antibody therapies reach patients.

How you might spend your days

• Providing strategic leadership for the design, development, verification, validation, transfer, and commercialization of drug-device combination products including prefilled syringe and autoinjectors
• Owning and overseeing combination product development strategies, design control activities, and Design History File (DHF) deliverables, ensuring compliance with applicable global regulatory requirements and industry standards
• Developing, mentoring, and leading a high-performing team of engineers, fostering a culture of scientific excellence, cross-functional collaboration, and continuous improvement
• Providing oversight of Human Factors (HF) strategies and activities, including instructions for use (IFU) development, HF formative studies through summative validation, and associated regulatory documentation
• Leading device-related risk management, technical due diligence, and gap assessments to de-risk technology transfers and scale-up efforts, ensuring fill-finish, assembly, and packaging operations can consistently deliver the Essential Drug Delivery Outputs (EDDOs) and associated critical quality attributes
• Driving external technical partnerships, holding CDMOs, suppliers, and consultants accountable to technical, quality, timeline, and budget objectives while optimizing project scope, work packages, and development strategies to maximize program value and efficiency
• Serving as the strategic owner for the drug-device interface, ensuring alignment between device input requirements, EDDOs, drug product characteristics, container closure systems, and manufacturing capabilities
• Guiding packaging, shipping, and distribution strategies for prefilled syringes and autoinjectors to ensure product quality, device performance, and supply chain robustness throughout the product lifecycle
• Partnering with Quality, Regulatory Affairs, Manufacturing, and Supply Chain teams to establish and maintain robust combination product quality management systems, supplier controls, and governance processes, while overseeing the development, implementation, and continuous improvement of medical device and combination product QMS procedures and supplier Quality Agreements
• Providing oversight of device-related regulatory documentation content supporting global clinical and commercial submissions (IND/CTA/BLA/MAA) and responses to health authority questions

We’d love to hear from you if

• You hold a Bachelor’s or post‑graduate degree in mechanical, biomedical, or chemical engineering, or a related field, and at least 15 years of meaningful, hands‑on experience in device engineering - giving you real depth in the development and commercialization of drug‑device combination products and pharmaceutical delivery systems
• You have a proven track record of advancing combination products, including prefilled syringes with safety devices, and autoinjectors, from clinical development through commercial approval
• You possess deep expertise in design controls and quality system requirements for combination products, with extensive experience applying FDA regulations (21 CFR 820.30, 21 CFR Part 4) and international standards (including ISO 13485, ISO 11608, ISO11040, ISO 14971, IEC 62366) throughout product development, risk management, registration, and lifecycle management
• You have the ability to mentor, inspire, and manage high‑performing technical teams in a fast‑paced biotech environment
• 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 this role is CAD $200,000 - $250,000 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.