Experienced in CGT process development, GMP manufacturing and tech transfer, regulatory, quality, project management, and VOC
Product & Process Development
Manufacturing Operations
Quality Assurance
Regulatory Affairs
Project & Program Management
Market Expertise
Uzma joined Dark Horse Consulting in 2019, bringing 12 years of prior industry experience in process development, technology transfer, and GMP manufacturing of cell and gene-modified cell therapy products, including modifications using Sendai and retroviral vectors.
While at Dark Horse, Uzma has specialized in helping clients with their CDMO selection, and given that range of experience, she has been able to build and expand upon the ever-growing DHC CDMO database. Much of her client work also includes either tech transfers or helping clients develop their quality systems…or both. She has also authored and/or reviewed a range of regulatory documents for clients working across at least five jurisdictions.
Uzma’s career started at Geron, a clinical stage biopharmaceutical company, where she was responsible for manufacturing hESC derived cell therapies in a cGMP setting. At Geron she learned to maintain strict cGMP manufacturing standards for equipment maintenance, and wrote SOPs, batch production records, and materials specifications. She also became a qualified clinical-site trainer for dose-prep and isolation of Geron’s GRNVAC1, an autologous dendritic cell vaccine targeting telomerase.
Uzma then moved on to research roles at iPierian and Cellogy, where she developed hands-on expertise in cell line development, stem cell differentiation, and cell banking. Using Sendai and retroviral vectors, she delivered gene constructs to primary tissue derived cell lines, and reprogrammed primary cells into iPSCs. Uzma was also responsible for optimizing protocols for differentiating iPSCs into a variety of different cell types, characterizing them, and preparing high quality cell banks. At both companies, Uzma designed and managed core facilities for cell culture. Her work at Cellogy on time-lapse imaging of iPSCs to evaluate cell lines for quality and health resulted in a publication in the Journal of Laboratory Automation.
In her most recent (pre-DHC) position as a Process Development Scientist at Asterias Biotherapeutics, Uzma was the lead trainer for an international tech transfer of AST-VAC2, an allogeneic cancer. She also designed and executed cell culture and scale-up processes to optimize the derivation of oligodendrocyte progenitor cells and dendritic cells from hESC cell lines. Her work on the process development of AST-OPC1, a stem cell transplant therapy to treat spinal cord injuries, resulted in a patent for Asterias.
Uzma continually maintains Dark Horse Consulting’s CDMO database which encapsulates an at-a-glance view of service providers in the CGT space.
Dark Horse Consulting Group
Consultant
Asterias Biotherapeutics, Inc.
Process Development Scientist
Senior Research Associate
Cellogy, Inc.
Staff Scientist
iPierian, Inc.
Research Associate
Geron Corp.
Manufacturing Associate
VaxGen, Inc.
Research Associate
San Jose State University
B.S. in Biological Sciences, Concentration in Microbiology & Minor in Chemistry
.png)
