Stephen Gacheru

Stephen Gacheru

Speaker
Frontage Lab

An executive leader with a passion for exploring and applying science to develop unmet medical therapies based on biologics, Gene and Cell Therapy platform. Experience in process development and analytical technology for innovative drugs.  Strong people leadership skills and experienced in managing high performing technical teams. Experience in leading operations and CMC teams responsible for development, manufacturing, and supply of clinical and commercial biological therapeutic products. Ensuring coordination, seamless communication, and execution across different departments and functions by building and nurturing close, trusting relationships, frequent interaction, and oversight of key deliverables. Increasing leadership roles in process and analytical development during drug development process with global experience in management and oversight of external manufacturers and construction of manufacturing and quality control facilities (Key team member of Orencia® (abatacept)Yervoy® (ipilimumab), and Opdivo® (nivolumab) technology transfer to South Korea. Lead FDA pre-approval inspection readiness (PAI) audits and global health inspections at CMO sites
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