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. H ow 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 W e’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 W hat 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. A bout 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 23398 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.
