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Emily Moran is the Founder of 3LB Consulting, a life sciences advisory firm focused on cell and gene therapy execution, spanning manufacturing strategy, CMC development, CDMO selection, and regulatory readiness.
With nearly two decades of experience across vaccines, biologics, and advanced therapies, Moran specializes in translating innovative science into manufacturable, compliant, and patient-ready products. Her work supports early-stage startups, academic spinouts, and late-stage biotechs navigating the complex path from discovery through IND, clinical trials, and commercialization.
Moran began her career as a manufacturing operator on the shop floor, developing a practical, systems-level understanding of GMP operations, quality systems, and regulatory compliance. She later spent significant time in highly regulated, global manufacturing environments, including work within Sanofi’s vaccine manufacturing ecosystem, where products were produced for worldwide distribution under stringent regulatory oversight.
Over the past seven years, she has worked extensively in cell and gene therapy, advising programs across autologous and allogeneic modalities, viral vector production, and advanced manufacturing platforms. Her experience spans process development, analytical strategy, raw material control, facility design, equipment selection, and GMP readiness.
She is particularly known for helping teams anticipate execution gaps early, reducing costly rework, regulatory delays, and loss of investor confidence.
Moran’s commitment to advanced therapies is shaped not only by professional expertise, but by personal experience. In 2012, her children participated in a Phase I clinical trial for a life-saving treatment, exposing her firsthand to the urgency, complexity, and emotional stakes involved in early-stage therapies.
This experience deeply informs her approach to consulting — combining operational discipline with patient urgency, and reinforcing her belief that safe, compliant manufacturing is the fastest path to access, affordability, and impact.
She regularly advises teams preparing for regulatory submissions, inspections, and strategic partnerships, and is known for bridging communication gaps between scientists, clinicians, quality teams, regulators, and investors.
