Amol Thote
Team Lead & Head Of Process Development Gilead Sciences
Dr. Amol Thote has established Cell & Gene Therapy Development & GMP Manufacturing Capabilities for regenerative medicines. He has also established digital capabilities for Cell Therapy CMC platform processes to setup process knowledge and control strategy. Beyond CMC, he has conceptualized patient-centric IoT based digital platform for vein-vein ecosystem with bench-to-bedside decentralized clinical trials models.
He has been a Biotech Global Launch Manager, Operations (Project and Program) Manager, Validation Manager and Process Development Scientist. He brings 18 years of experience in biotech early-stage process development, late-stage technology transfer, process and cleaning validation, manufacturing implementation and product launch.
Seminars
- Outlining what regulators expect from PPQ runs in viral vector manufacturing: consistency, reproducibility, and demonstration of process control across multiple consecutive batches
- Sharing strategies for scaling processes developed at early-stage to commercialready platforms without compromising quality or timelines
