Steven Feudo, Principal

Chemical engineer with over 10 years of specialized experience in biopharmaceutical manufacturing across multiple therapeutic modalities including gene therapy, highly-engineered antibodies, protein therapeutics, and early-stage clinical biologics.

Proven track record of delivering critical tech transfers in record time. Built manufacturing dashboards and data tracking systems that provided executive-level visibility across multimillion-dollar programs, enabling strategic decision-making and operational excellence.

Led FDA interactions and authored regulatory submissions including BLA content, IND-enabling documentation, and process validation strategies. Successfully managed complex manufacturing operations at external CDMOs while serving as the technical lead during periods of accelerated program development.

Deep expertise spanning the entire biopharmaceutical value chain from bench-scale research through commercial manufacturing, with leadership experience across organizations ranging from innovative startups to Fortune 500 companies including Sarepta Therapeutics, National Resilience, ThermoFisher Scientific, and Alkermes.