Director, Combination Products & Device Development

<p>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.</p> <p>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.</p> <p><strong>H</strong><strong>ow you might spend your days </strong></p> <ul> <li>Providing strategic leadership for the design, development, verification, validation, transfer, and commercialization of drug-device combination products including prefilled syringe and autoinjectors </li> <li>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</li> <li>Developing, mentoring, and leading a high-performing team of engineers, fostering a culture of scientific excellence, cross-functional collaboration, and continuous improvement</li> <li>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 </li> <li>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 </li> <li>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</li> <li>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</li> <li>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</li> <li>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</li> <li>Providing oversight of device-related regulatory documentation content supporting global clinical and commercial submissions (IND/CTA/BLA/MAA) and responses to health authority questions</li> <li> </li> </ul> <p><strong>W</strong><strong>e’d love to hear from you if</strong></p> <ul> <li>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