Hershey San Agustin Tovera
About Hershey San Agustin Tovera
Hershey San Agustin Tovera serves as the Associate Director of Regulatory Affairs at Kite Pharma, bringing over 17 years of experience in the biotechnology sector, with a strong focus on patient safety and product quality.
Current Role at Kite Pharma
Hershey San Agustin Tovera serves as the Associate Director of Regulatory Affairs at Kite Pharma, a position he has held since 2021. In this role, he is responsible for overseeing regulatory strategies and ensuring compliance with FDA guidelines and regulations for Biologic Products. His work focuses on maintaining patient safety and product quality within the organization.
Previous Experience in Regulatory Affairs
Prior to his current role, Hershey held various positions in regulatory affairs across multiple companies. He worked as a Senior Manager of Regulatory Affairs at Kite Pharma from 2019 to 2021. Before that, he was a Sr. Manager of Regulatory Affairs at Atara Biotherapeutics for seven months in 2018-2019. His experience includes roles at Baxter International Inc. and Baxalta, where he contributed to regulatory compliance and documentation.
Education and Expertise
Hershey San Agustin Tovera holds a Bachelor of Arts in Psychology from California State University-Los Angeles and a Master of Science in Regulatory Affairs from Northeastern University. His educational background supports his strategic experience in Regulatory Affairs, particularly in Chemistry, Manufacturing, and Controls, which spans over five years.
Background in Biotechnology
With over 17 years of experience in biotechnology companies, Hershey has developed a strong focus on patient safety and product quality. His background includes extensive knowledge of fractionation, bulk manufacturing formulation, sterile filtration, and aseptic filling of plasma-derived products. He is proficient in writing and reviewing GMP documentation and regulatory documents.
Leadership and Team Management Skills
Hershey demonstrates established leadership capabilities with exceptional team-building skills. He has successfully led multi-facility and multi-function teams, driving them towards successful outcomes. His ability to manage diverse teams is complemented by his proficiency in various software tools, including MS Word, Excel, PowerPoint, FirstDoc, and Trackwise.