Dawn Houlihan

Prior to Ensoma, Dawn Houlihan served as senior director of QA operations at Flexion Therapeutics, where she led the QA operations team to achieve NDA approval and commercialization of ZILRETTA®. Dawn also led quality operations for the FX201 gene therapy program, ensuring CDMO readiness, process, and product control strategy, and phase-appropriate quality systems, leading to an on-time filing of the IND and first-in-human studies.

Previously, Dawn spent much of her career in a range of quality roles within Janssen Biologics, where she provided QA guidance and leadership to several monoclonal antibody programs.

Dawn holds a BSc. degree from University College Cork (Ireland), and post-graduate certifications in Upstream Biopharmaceutical Processing from Cork Institute of Technology and FDA Quality System Requirements and Industry Practice from the AAMI University.