Cell and Gene Therapy Process Development - Leading a PD team in autologous and allogeneic CAR-T therapy

Process Development Scientist working on CAR-T cell therapy and gene therapy Design, commission and troubleshoot custom automated processing equipment Design and execute experiments to investigate and characterize cell therapy production processes Serve as SME in tech transfers, training and regulatory filings

•Served as on-site system integrator and validation lead for various commercial scale pharma projects.•Authored specification documents for GMP manufacturing systems. Authored and executed validation protocols.•Identified and resolved issues associated with industrial control systems during start-up / validation operations.

Worked as a process engineer supporting manufacturing of Hemopure and Oxyglobin (Oxygen Therapeutics) •Lead engineering and automation activities in support of an FDA audited commercial GMP manufacturing facility •Authored and contributed to technical documents including specifications, investigation and validation studies, and engineering test plans •Collaborated with cross-disciplinary teams comprised of R&D, validation, regulatory, process development, outside vendors and quality assurance groups in managing change process.

•Collaborated with early phase teams in developing mammalian cell culture upstream production processes.•Led upstream pilot operations in efforts to produce development material and obtain insight into new processes at large scale. Documented and analyzed data, and communicated results in a matrix setting.•Identified opportunities for novel technical research projects, designed and executed studies to investigate relevant issues, and published/presented the results at scientific conferences.

Designed and developed cell culturing system for the use of engineering vascular grafts Developed instruments for use in cardiovascular cellular mechanics studiesPerformed biocompatibility experiments involving new polymer designs