Darius Pillsbury ValSource, Inc.

Darius Pillsbury is a senior consultant at ValSource. He holds a Bachelor of Science in Chemical Engineering from Tufts University and has more than 25 years of experience working within the Biotech/Pharmaceutical industry. Darius worked on the development and validation of manufacturing processes in the Manufacturing Science and Technology department at ImClone Systems and Eli Lilly. He subsequently worked as the Director of Validation at the rare disease company, Ultragenyx, and as the Director of Quality Lifecycle Management at the cell and gene therapy company, Adaptimmune. Darius has extensive experience in the establishment and implementation of science-driven and risk-based Control Strategies as a part of the overall process validation lifecycle approach. Darius is a member of the PDA ATMP Advisory Board and has many additional contributions to PDA including as an author of the Points to Consider for Plasmids and Vectors In ATMP Production and the current revision to Technical Report 60: Process Validation Lifecycle Approach. In addition, he is a contributor to the PDA Annex 1 commenting team and the working groups for the standards on the topics of Cryopreservation of Cells for Use in Cell Therapies and Regenerative Medicine and Apheresis Cell Collection.