Head of Technical Operations
Diane Blumenthal is Head of Technical Operations at Spark Therapeutics, where her responsibilities include manufacturing, quality control, cGMP and scientific facilities, supply chain and network strategy. She is responsible for leading the CMC (chemistry, manufacturing and controls) efforts that led to the first approval of a gene-therapy product in both the US and EU, which included the US and EU approval of Spark’s manufacturing facility to produce a gene-therapy product.
Overall, Ms. Blumenthal has more than 30 years of experience in the use of recombinant DNA technology for the expression and manufacture of biotechnology products. Throughout her career, she has played a key role in the development and commercialization of multiple pharmaceutical products, including the cancer drugs, Erbitux (cetuximab) and Cyramza (ramucirumab), and most recently the gene therapy, Luxturna (voretigene neparvovec-rzyl). She has extensive experience in the transfer and scale-up of processes from the laboratory bench to commercial-scale manufacturing with expertise in both microbial and mammalian cell-culture expression systems and the corresponding downstream purification processes.
Prior to joining Spark Therapeutics, she served as Vice President of Manufacturing Sciences and Technology for Eli Lilly and Company, following Eli Lilly and Company’s acquisition of ImClone Systems in 2008. In this role, she was responsible for leading a multi-disciplinary team of scientists, statisticians, and engineers tasked with providing technical support to manufacturing, development, quality control, quality assurance, and regulatory teams. During her time at ImClone Systems, she and her team were responsible for the implementation of novel methodologies used for the demonstration process and product comparability.
Prior to her tenure at Eli Lilly and Company, Ms. Blumenthal served as a scientific and manufacturing consultant to multiple start-up biotechnology companies and held scientific leadership positions at Zymquest, Inc., Scios, Inc. (formally California Biotechnology), and the Eastman Kodak Company.
She received her M.S.E. in chemical engineering from Lehigh University and a B.S.E. in bioengineering from the University of Pennsylvania.