Experienced in CGT process development, GMP manufacturing and tech transfer, regulatory, quality, project management, and VOC
CMC
Quality & Compliance
Regulatory
Business Analytics
Uzma joined Dark Horse Consulting in 2019, bringing over 12 years of prior industry experience in process development, technology transfer, and GMP manufacturing of cell and gene-modified cell therapy products, including deep expertise in pluripotent stem cells. Uzma recently successfully passed the PMP exam and earned the Project Management Professional (PMP)® certification from Project Management Institute.
While at Dark Horse, Uzma has specialized in helping clients in many areas of CMC. She has written regulatory documentation for multiple jurisdictions, performed risk assessments and due diligence activities, and been a primary technical writer for clients requiring support in drafting reports, standard operating procedures, and batch records. She has built a client’s quality management system from scratch. Additionally, Uzma has conducted voice of customer surveys and market research analysis for various cell therapy and tools & tech companies, led several tech transfers and training activities, and been a person-in-plant (PiP). Uzma has assisted many 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. In addition to helping clients with selecting a suitable service provider, she has been on many CDMO on-site evaluations including participating in quality audits as a technical SME.
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
