Kelly Caroline Kemp

Kelly Caroline Kemp has extensive experience in process development and management in the biotechnology and pharmaceutical industries. Kelly Caroline has held various roles in different companies, including ViaCyte, Organogenesis, Vital Therapies, Inc., Stemedica Cell Technologies, Shire Pharmaceuticals, Stemgent, ScholarNexus LLC, Salk Institute for Biological Studies, Vrije Universiteit Brussel, and Howard Hughes Medical Institute.

At ViaCyte, Kelly currently serves as the Senior Director of Chemistry, Manufacturing & Controls (CMC). In this role, they are responsible for overseeing the chemistry, manufacturing, and controls processes related to the production of a cell-based product. Prior to this position, they served as the Director of Process Development, where they built a team to support process characterization and improvement projects.

At Organogenesis, Kelly worked as a Process Development Consultant, supporting the development of a specialized scaffold for the production of a skin substitute. Kelly Caroline also participated in activities related to the preparation of a Biologic License Application (BLA) for an amniotic-based commercial product.

During their tenure at Vital Therapies, Inc., Kelly held the positions of Director and Associate Director of Process Development. In these roles, they led the development and transfer of process improvements for a combination device-biologic drug product and built a Process Development department. Kelly Caroline also performed a thorough investigation of manufacturing processes and provided process improvement recommendations.

At Stemedica Cell Technologies, Kelly served as an Associate Director of Process Development, where they built and managed a team focused on evaluating and developing new technologies and processes. Kelly Caroline also completed a scale-up cell expansion platform analysis.

Kelly worked as a Process Development Scientist at Shire Pharmaceuticals, where they characterized cell and tissue growth processes to improve process robustness and decrease lot variability of a regulated product. Kelly Caroline also provided technical advice for manufacturing deviations and regulatory submissions.

At Stemgent, Kelly held various roles, including Senior Scientist, QC Manager, Production Planner, and QC Scientist. In these positions, they managed scientists and associates, performed routine QC testing, and reduced lead time and backorders through process optimization.

Kelly also worked as a Consultant at ScholarNexus LLC, conducting consulting work in the biotechnology industry.

In addition, Kelly has research experience from their time at the Salk Institute for Biological Studies and Vrije Universiteit Brussel. At the Salk Institute, they studied the regulation of Wnt target gene expression in human embryonic stem cells. At Vrije Universiteit Brussel, they investigated gene expression patterns and produced chimeric mice.

Early in their career, Kelly worked as a Research Assistant at the Howard Hughes Medical Institute, where they studied early mouse development.

Overall, Kelly Caroline Kemp has a strong background in process development, project management, and scientific research in the biotechnology and pharmaceutical fields.

Kelly Caroline Kemp has a Bachelor of Science (BS) degree in Microbiology and Molecular Genetics from UCLA. Kelly Caroline also holds an Associate of Arts (AA) degree in General Studies from Irvine Valley College. Furthermore, Kelly has a Doctor of Philosophy (PhD) degree in Developmental Biology from Vrije Universiteit Brussel.