Sandoval to lead process development, manufacturing and quality operations for leading-edge biosimilar developer
Pfenex Inc., announced that Steven. S. Sandoval Sr. has joined the company as Chief Manufacturing Operations Officer, focused on leadership of process development, clinical and commercial manufacturing and quality operations.
Sandoval joins Pfenex with over 25 years of commercial biopharmaceutical engineering and operations experience, specializing in commercial operations, facility design and licensure of large scale biopharmaceutical commercial manufacturing facilities. He has extensive knowledge of cGMP biopharmaceutical engineering as well as significant first-hand experience preparing for and interfacing with the FDA and other global regulatory agencies during pre-licensure and biennial inspections of commercial cGMP biopharmaceutical manufacturing facilities.
Prior to joining Pfenex, Sandoval was a member of Amgen’s site executive management leadership team responsible for the aggressive growth at the Puerto Rico manufacturing site, where he led the engineering team in taking a large scale $600MM biopharmaceutical multiproduct manufacturing facility from conceptual design to licensure in two and half years.
“Steven’s wealth of experience will have a direct impact on Pfenex at a crucial inflection point as we advance our portfolio of products toward commercialization,” said Bert Liang, President & CEO, Pfenex Inc. “We are thrilled to welcome Steven to our growing and dynamic team.”