Lei Fang
About Lei Fang
Lei Fang serves as the Vice President of Product Development at Alamar Biosciences, Inc., where he has worked since 2023. With nearly two decades of experience in molecular biology and diagnostics, he specializes in developing molecular diagnostic assays and has extensive knowledge of FDA regulatory processes.
Work at Alamar Biosciences
Lei Fang serves as the Vice President of Product Development at Alamar Biosciences, Inc., a position he has held since 2023. Located in Fremont, California, he has been instrumental in advancing the company's product development initiatives. Prior to this role, he was the Senior Director of Product Development at Alamar from 2020 to 2023. His leadership in product development has contributed to the company's focus on molecular diagnostics.
Education and Expertise
Lei Fang earned a Ph.D. in Genetics from The University of Georgia. His academic background provides a strong foundation for his nearly two decades of experience in research, particularly in molecular biology, cell biology, and virology. He specializes in the creation and development of molecular diagnostic assays, leveraging his extensive knowledge in the field.
Background in Product Development
Lei Fang has a diverse background in product development across several organizations. He worked at Predicine Inc. as Senior Director of Product Development and Operation for seven months in 2017. He also held positions at Celera Diagnostics as a Senior Scientist from 2007 to 2011 and at Sequenta, where he was Associate Director of Product Development from 2011 to 2015. His experience includes roles at Adaptive Biotechnologies Corp. as Director of Product Development from 2015 to 2017.
Regulatory Knowledge in Molecular Diagnostics
Lei Fang possesses extensive experience with regulatory processes in the molecular diagnostic field, including FDA 510(K) and PMA applications. He is knowledgeable in Design Control, CLIA, CAP, Verification and Validation Study Design, GLP, GCP, and GMP. His expertise ensures compliance with industry standards and regulations, facilitating the successful registration of molecular diagnostic products.
Research Experience
Lei Fang has a strong research background, having worked as a Postdoctoral Fellow at The Salk Institute for Biological Studies from 2004 to 2007. His research experience spans nearly two decades, focusing on molecular biology, cell biology, and virology. This extensive research background informs his approach to product development and innovation in the molecular diagnostics sector.