Quality Assurance Personnel
Bruce Burnett, PhD, RAC
Dr. Burnett has over 20 years of pharmaceutical industry experience in quality control/assurance and regulatory affairs.
He recently served as the Acting Director of the Office of Research Support and Compliance (ORSC) at NIH within the Office of the Director and now continues at NIH as an advisor to ORSC.
At Duke, he supports translational research as the Director of the Regulatory Affairs and Quality group. Dr. Burnett came to Duke from Alpha Vax, a vaccine biotech company where he last served as Vice President of Regulatory Affairs and Quality.
Dr. Burnett joined LCGM in November 2018.
Kunjan holds a Master of Science in Regulatory Science. She joined Stanford Laboratory for Cell and Gene Medicine (LCGM) as a Quality Assurance Associate in 2017. In her past roles in Quality Assurance, she has managed quality systems such as Deviations, CAPA, Internal Audit, and Supplier Qualification. She has also been responsible for Manufacturing Batch Record Review, Stability Program Review and Training. She has over 8 years of combined experience working in Pharmaceutical Marketing and Quality Assurance.
Miguel joined the Laboratory for Cell and Gene Medicine as a Quality Assurance Associate in 2018. He received his Bachelor of Science degree in Biological Sciences from the University of California - Davis, and has a M.B.A. from California State University - East Bay. He has 20 years of combined experience working in Quality Control and Quality Assurance.
In his past roles, he has supervised the Quality Control Environmental Monitoring, Raw Material Testing, and Sample Management groups, and provided Quality Assurance oversight of both Quality Control and Media Prep/Reagent groups. He has also been responsible for Deviation/CAPA management, Change Control, Equipment Validation, Internal/External Audits, and Training.
Senior QA Associate
Miles joined the Laboratory for Cell and Gene Medicine as a Quality Assurance Senior Associate in 2021. He received his Bachelor of Arts degree in English, with a minor in Economics from the University of California, Merced in 2017. Prior to joining LCGM Miles worked in quality assurance at various biotech companies and startups in the San Francisco Bay Area.
William joined the Laboratory for Cell and Gene Medicine (LCGM) in 2021 as a Quality Assurance (QA) Associate. He received a B.S. in Physics from University of California, Davis. Prior to joining LCGM, he was an undergraduate researcher at a theoretical biophysics group.
Vivian joined the Laboratory for Cell and Gene Medicine (LCGM) in 2021 as a Quality Assurance (QA) Associate. She received a B.S. in Cell, Molecular, and Developmental Biology from University of California, Riverside. Prior to joining LCGM, she worked as a research assistant specializing in tobacco-related diseases, electronic cigarettes, and stem cell biology led by Dr. Prue Talbot at UC Riverside. In addition to research, she has had over 2 years of clinical experience in the healthcare industry.
Arlene joined Laboratory for Cell and Gene Medicine (LCGM) in March 2017 supporting clinical manufacturing operations and quality systems development and implementation. Prior to LCGM, her background was in commercial parenteral manufacturing. She has a passion for building and leading teams, building systems and process improvements. She has gained 13 years experience (and counting) in a GMP environment and continues to grow in a Quality role.
Arlene holds a B.S in Business Management from Menlo College.
Priyanka joined the Laboratory for Cell and Gene Medicine (LCGM) as a Quality Assurance Associate in 2018. She received her Master’s in Science from University of Rhode Island.
Prior to joining LCGM, Priyanka gained 3 years of cGMP experience working for pharmaceutical companies. She has previously managed change control, batch record review, equipment validation and training. At LCGM she provides quality systems support for Phase III clinical trial of cellular therapy for Epidermolysis Bullosa led by Dr. Jean Tang at Stanford University.
Senior QA Associate
Aylin is a Senior Quality Assurance Associate at the Laboratory for Cell and Gene Therapy (LCGM). She received her BS in Pharmaceutical Sciences from University of California, Irvine. Prior to joining LCGM, Aylin worked as a quality control technician and research assistant in a pre-clinical research facility.
Hung Song Thai
Hung received his Bachelor of Science degree in Biochemistry from State University of San Jose. He has over 25 years of combined experience in the industries. Some of the few years included are Research Associate, Clinical Manufacturing, Analytical Chemist, MIS Engineer for a networking company and, Human Resource Generalist. He started his Quality Assurance career in February 2002 and progresses onward with the quality systems of Non-Conformance, IR, Deviation, CAPA, Change Control, Equipment Validation, Internal and External Audit, and Training. He's also worked a few years as a Quality Assurance Specialist for a medical devices company that certified under ISO 13485/14971.
As a part of his professional development, he has received an online Certificate of Training in Regulatory Affairs from Duke University in May 2020, during the Covid-19 shutdown. Other Certificates received from previous industries are for Train the Trainer, Training Certificate QSR 21CFR… and ISO, Product Complaints – FDA best practices and industry benchmarking for effective complaint processing, trending and analysis, Crucial Conversation, BMRAM Certificate, and 5S Certificate.
Hung joined LCGM in June 2021.