Experienced cell and gene therapy development leader with a drive to build CMC capabilities and manufacturing platforms from preclinical process/assay invention through to constructing and defending CMC modules for commercial applications, all pursued with scientific rigor and quality, and with the goal of making important therapies available to patients in need.• Breadth of experience successfully leading CMC functions for companies developing cell therapies and viral vector therapies from preclinical through post-commercial approval stages• Depth of technical and compliance knowledge across cell therapy-focused process and analytical development, materials compliance, technology transfer, manufacturing, QC, quality systems, validation, comparability studies, and cryopreserved product storage and distribution • Directly managed three clinical manufacturing operations with a combined output of nine different clinical parenteral cell and virus products • Experienced CMC strategist based on history of authoring, editing and defending cell therapy CMC modules via INDs, IMPDs, CTAs, mid- and late-phase amendments, and commercial applications (MAA, BLA); as well as being a practiced orator in regulatory interactions • Experienced at selecting and managing contract manufacturers, labs, services and consultants • History of successfully building capabilities and developing staff across functional disciplines of process development, analytical development, materials science, MSAT and manufacturing