Quality Assurance Personnel

Bruce Burnett, PhD, RAC  

Director

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 Kamdar

Associate Director

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 Valente

QA Manager

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.

 

Jenny Chao

QA Specialist

Jenny joined the LCGM in September 2019. She holds a Bachelor Degree in Chemical Engineering from UCLA. She has over 16 years of cGMP experience working in Biotech and Pharmaceuticals Companies.  In her past roles, she has worked in Manufacturing Operations, Quality Control, Quality Assurance Operations and Quality Assurance Validation.

Miles Harget

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.

Arlene Ajoste

Associate Director

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.

Jasminka Jakovljevic

Administrative Associate I

Jasminka Jakovljević joined the Laboratory for Cell and Gene Medicine as Materials Management Specialist in May 2016. She is responsible for the materials management and administrative operations of the department.

Prior to joining Stanford, Jasminka was Account Manager at the Société Générale Group in New York, where she was in charge of overseeing and managing the financial and administrative affairs of International Banks and Institutions investing on the U.S. market.

Jasminka studied languages at the Belgrade University in Serbia, and is fluent in English, French and Serbian. 

Priyanka Patel

Senior QA Principal Specialist

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.

Aylin Yalcin

QA Associate

Aylin is a 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.

Calvin Saechao

Senior QA Associate

Calvin joined Laboratory for Cell and Gene Medicine (LCGM) in February 2021 as a Senior QA Associate. He earned his B.S in Biomedical Engineering from San Jose State University. Prior to LCGM, Calvin began his career as a R&D engineer intern and found his passion for Quality Assurance when working for a medical device company. Calvin has a background in working in an ISO13485 certified quality system. In his previous role he managed quality tasks such as risk management, change controls, lot/batch record release, CAPA’s and external/internal audits.