Jean Stanton

Jean is currently Director, Global Cell Collection for Janssen Pharmaceuticals. She is responsible to drive the comprehensive and integrated strategy and executional plans to ensure quality apheresis starting material for product manufacturing. Jean ensuring sustainable business solutions for future demand.  Before assuming this role, Jean managed the R&D compliance program for Janssen, covering all GTP/ GMP compliance aspects for products in development. This included the development of quality and compliance strategies to support new platforms in development. Jean joined Janssen in 2008 after more than 20 years in the health care industry, manufacturing cell- based therapies.

Jean co-chaired the Parenteral Drug Association’s Cell and Gene Therapy Task Force which successfully developed a Technical Report, covering the design of a control strategy for cell and gene therapy. The report highlights an approach for early-stage cell therapy products in development, based on established concepts risk management tools are central to identifying the product attributes and demonstrating the relationships that link product profile to quality attributes, material attributes and process parameters.

Jean joined Janssen in 2008 in quality to support product development for cell-based products. During that time, she deployed the first Quality Manual for Cell Therapy Manufacturing within Janssen.   Prior to joining Janssen, Jean administered the Quality Management Program for the Hospital of the University of Pennsylvania Hospital (HUP), after many years managing collection sites and cell laboratories throughout the Philadelphia area.