Progress in the rapidly growing cell and gene therapy field continues to be limited by a shortage of trained and skilled individuals in current good manufacturing practices (cGMP; GMP). The workface shortage is felt across all functional units; Process and Analytical Development, Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Facilities & Operations. The Stanford Cell and Gene GMP Certificate Program is designed to provide foundational and ongoing training in GMP and contribute to the cell and gene therapy workforce.
The Stanford Cell and Gene GMP Certificate program is designed to kickstart careers for entry level applicants in the CGT manufacturing and quality workforce.
Program Components and Outcomes
The GMP certificate will be awarded upon completion of concentrated GMP-focused training. The program provides an opportunity for training not only in GMP-specific skills, but also in cell and gene manipulation, processing and production, new applications, product manufacturing, quality and regulatory oversight.
The Cell & Gene GMP Certification program is in the final stages of development, deployment, and assessment.
Questions?
Contact GMP Program Manager, Mona Shah, at lcgm_opportunities@stanford.edu
Mona Shah, MBA
Program Leadership
Program Director
Steven Feldman, PhD
Dr. Feldman is the Site Head and Scientific Director of the Laboratory for Cell and Gene Medicine.
Advisory Committee
David Miklos, MD, PhD
Dr. Miklos is the co-Executive Director of the Laboratory for Cell and Gene Medicine and Clinical Director of Cancer Cell Therapy at the Stanford Cancer Institute.
Anthony Oro, MD, PhD
Dr. Oro is the Eugene and Gloria Bauer Professor of Dermatology, Associate Director of the Center for Definitive and Curative Medicine, and the co-Director of the Child Health Research Institute.
J. Fraser Wright, PhD
Dr. Wright is the Professor of Pediatrics at the Center for Definitive and Curative Medicine.
Matt Porteus, MD, PhD
Dr. Porteus is the co-Executive Director of the Laboratory for Cell and Gene Medicine, Sutardja Chuk Professor and Director of Definitive and Curative Medicine for the Division of Hematology, Oncology, Stem Cell Transplantation and Regenerative Medicine.
Mentors
Bruce Burnett, PhD
Dr. Burnett is the Quality Assurance Director at the Laboratory for Cell and Gene Medicine.
Guangwen Wang, PhD
Dr. Wang is the Process Development and Manufacturing Director of the Center for Definitive and Curative Medicine at the Laboratory for Cell and Gene Medicine.
Catherine McIntyre, PhD
Dr. McIntyre is the Operations and Scientific Director of the Bone Marrow Transplant & Cellular Therapies Division.
Kathryn Melsop
Kathryn is the Finance and Facility Operations Director at the Laboratory for Cell and Gene Medicine.
Ramya Tunuguntla, PhD
Dr. Tunuguntla is the CMC Technical Operations Director of Cancer Cell Therapy at the Laboratory for Cell and Gene Medicine.