Justin L. Burt

Executive Director, Synthetic Process Development @Alexion Pharmaceuticals, Inc.

Founding member of Alexion’s Synthetic Process Development (SPD) group. Led the rapid evolution of SPD from a team of one in 2019, to an agile and growing team of 23 process chemists, engineers, and pharmaceutical scientists. • Delivering safe, scalable, and efficient manufacturing processes, and developing strategies for technology transfer, scale-up, and process validation that ensure reliable and timely delivery of synthetic drug substance and OSD drug product to meet clinical and commercial demand. Anticipating and proactively communicating potential technical risks, and developing nimble risk mitigation strategies. • Accountable for process and product design strategy and execution, defining and managing development timelines and resource requirements, and ensuring technical stewardship for third-party development, manufacturing, and process validation activities, as well as authoring of regulatory submission documents. Extensive collaboration with Alexion Quality Affairs, Regulatory Affairs, Technical Operations, Analytical Science, Clinical Supply, and CMC program management. • Coaching, mentoring, and developing our high-performing team of SPD technical professionals.