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Steven Falcone
ElevateBio, a technology-driven advanced therapy contract development and manufacturing organization (CDMO) and gene editing services partner, has appointed Steven Falcone as Chief Operating Officer.
Falcone brings more than 30 years of experience across technical operations, quality systems, inspection readiness, supply chain, and site management.
In his new role, Falcone will oversee operations and quality for ElevateBio, supporting compliant and efficient manufacturing and testing at the company’s sites in Waltham, Massachusetts, and Pittsburgh, Pennsylvania. His experience in operational transformation and advanced therapies will support ElevateBio’s mission to reduce the cost of producing innovative treatments.
Falcone joins ElevateBio from Novo Nordisk, where he served as Vice President of Quality Complaints, Audit and Inspections, and Quality Intelligence. In this role, he helped establish strategic direction for the company’s global audit, inspection, and complaint programs.
Previously, Falcone served as Chief Quality Officer at Brammer Bio, which was acquired by Thermo Fisher. He also held Vice President and Senior Director positions at Thermo Fisher, where he transformed inspection readiness and external engagement programs and supported the development of services for advanced therapies, including plasmid, mRNA, cell therapy, and regulatory affairs.
Earlier in his career, Falcone served as Vice President of Quality at Sanofi Genzyme and held various quality and operational leadership roles at Amgen, Solstice Neurosciences, and Bayer.
Throughout his career, Falcone has led quality and compliance strategies supporting the commercialization and global launch of numerous marketed products. His expertise includes technology transfer, commercialization, quality systems, and inspection readiness across multiple jurisdictions.
Falcone holds a B.S. in Chemistry from the University of California, Berkeley. His extensive operational and quality leadership experience will support ElevateBio as it advances manufacturing capabilities for complex advanced therapies.
