“Delivering complex large molecule therapeutics, in timelines our patients need, requires a focused process development team dedicated to excellence in science as well as efficiency in operations execution. They must have the agility to perfect details with quality informed by the ability to see where their work fits to complete a successful big picture. A picture which contains at the end of the line a cured patient.”
Simin Zaidi has a Bioprocess Engineering Degree from the University of New South Wales in Kensington, Australia. In her current role at the University of Pennsylvania Gene Therapy Program (GTP), she works with an internal team of scientists and engineers to develop, scale-up and transfer manufacturing processes to produce gene therapy vectors for patient use. The manufacturing processes are executed internally to produce products for non-human Toxicology Studies then transferred to external Contract Manufacturing Organizations for cGMP manufacturing.
Simin has over 19 years of experience in the biopharmaceutical industry in therapeutic protein process development and manufacturing, taking candidates through the increasing regulatory stringencies of early phase clinical through commercial use. In her most recent role, Simin was Director of Manufacturing Sciences at Catalent Biologics and over her career has developed and/or tech transferred processes for dozens of products. Simin also has a Graduate Certificate in Business Management from the Kelley School of Business at Indiana University and has several publications on biologics process development.