Nicole Sabo Email and Phone Number

High level of proficiency in multiple areas of biomanufacturing and cell therapy including cell line generation, bioreactor process development and process characterization, technology transfer, process monitoring, bioreactor support in non-GMP and GMP manufacturing facilities, identify process gaps and gap closures, regulatory filings, author technical reports, IND, BLA, and IMPD. Biotechnology CMC biologics and cell therapy professional with 25+ years' experience supporting internal and external manufacturing, including PiP oversight and business management of CDMOs, raw material suppliers, and equipment validation. Experience ranges from early-phase clinical drug substance manufacturing and process development to late-stage development and commercialization including PC, PPQ, CMC dossier development for INDs, IMPDs, and BLAs, CPV, commercial lifecycle management, and commercial manufacturing. PMP certification training ongoing.