Satyakam Singh Ph D

 I strategically built and lead Process and Analytical Development Operations, that emphasizes the long-term strategies of development, qualification, validation, tech transfer, and CMC life cycle management. This encompasses training CDMO personnels, ensuring robust standards, troubleshooting and providing technical oversight for scalable cell therapy manufacturing.  I oversee continuous improvements in the process and Analytical development, for Retrovirus derived Allogenic CAR-NK cell and Lentivirus derived Autologous CAR-T manufacturing and testing’s, along with critical materials such as feeder Cells and other cell therapy reagents and provide technical leadership for the preparation of regulatory submissions related to CMC considerations. Our lab collaborates closely with a CDMO to facilitate process and analytical method transfer, ensuring the consistency of outcomes in both our internal and external testing endeavors.  I provide technical support for manufacturing runs and collaborate closely with regulatory, Quality, Business, Supply Chain, and Clinical operations. I am responsible for developing and submitting INDs, planning drug product manufacturing operations, and designing clinical trial strategies.