Prathiba Sampath

Prathiba Sampath has over 10 years of experience in the biopharma industry and has led multiple projects in process engineering, validation, CMC and program support. Prior to consulting, Prathiba was a Sr Manager, External Manufacturing at Sangamo Therapeutics, where she led the site selection and lentivirus manufacturing oversight of CMOs for CAR-T cell therapy programs, supported Regulatory, CMC and Program groups through the clinical phases. Prathiba is experienced in process characterization, FMEA (risk based approach) and process validation and has supported many tech transfers for cell therapy, mRNA vaccine and mAb programs through MSAT and project management capabilities. Prathiba has also led project management and process engineering & design  efforts for facility expansion and build-out projects and has performed modeling activities in SuperPro and SchedulePro to provide engineering solutions. Prathiba has vast experience with analytical equipment and has led CQV and process validation strategies and implementation in facility projects. Prathiba has managed change controls, CAPAs, deviations and has led GMP investigations in support of cell banking and upstream cell culture processes. Prathiba has also authored many technical documents, SOPs, project plans, technical protocols, comparability studies, and associated reports and is proficient in technical writing. Prathiba has received a masters’ degree in Chemical Engineering from University at Buffalo, SUNY, leadership certification from Stanford University (Stanford LEAD) and PMP from Project Management Institute.