Niraj Ramachandran | Senior Director - Cell and Gene Therapy (CMC)
Genentech

Strategic Regulatory CMC Leader with extensive expertise in Cell & Gene Therapies (CGT), biologics, and tissue engineering. Proven track record of navigating the transition from early-phase development to commercial lifecycle management. Expert at authoring robust BLA/MAA/IND submissions and leading high-stakes health authority negotiations. A collaborative leader focused on mitigating risk, ensuring supply chain continuity, and driving complex global projects to completion on time and within budget.