Shawn O’Brien is the Senior Director of Operations and Site Head at Alphazyme, a Maravai LifeSciences company, where he leads GMP manufacturing operations, facilities, quality collaboration, and strategic site growth initiatives. His experience spans enzyme manufacturing, cell and gene therapy, sterile pharmaceutical manufacturing, and CDMO operations, with a focus on facility start-ups, operational excellence, and commercialization readiness.

Throughout his career, Shawn has led the design, construction, commissioning, qualification, and operational launch of multiple GMP manufacturing facilities, including cell and gene therapy facilities and a recently completed 5,000-square-foot GMP enzyme manufacturing cleanroom facility. He has successfully guided organizations through facility start-up, process validation, regulatory readiness, and commercial manufacturing launch activities while managing cross-functional teams across Manufacturing, Quality, Validation, Facilities, Supply Chain, and Technical Operations.

Prior to joining Alphazyme, Shawn held leadership roles supporting the commercialization of groundbreaking advanced therapies, including Bristol Myers Squibb’s Breyanzi® CAR-T cell therapy and Vertex Pharmaceuticals’ CASGEVY®, the first FDA-approved CRISPR-based gene-editing therapy. He has extensive experience supporting regulatory inspections and approvals, including interactions with FDA, EMA, and HPRA regulators.

Shawn is passionate about bridging the gap between facility design and manufacturing execution, ensuring GMP facilities are designed not only for compliance but for long-term operational success, scalability, and inspection readiness.