Jacky Lei
About Jacky Lei
Jacky Lei is a Lead QA/QC professional with over 20 years of experience in quality operations within clinical and commercial settings. He has held significant roles at various pharmaceutical companies, including TESARO, Momenta Pharmaceuticals, and Sunovion Pharmaceuticals, and currently works at Amylyx Pharmaceuticals.
Current Role at Amylyx Pharmaceuticals
Jacky Lei serves as the Lead QA/QC at Amylyx Pharmaceuticals, a position held since 2021. In this role, he oversees quality assurance and quality control processes, ensuring compliance with regulatory standards. His responsibilities include managing quality operations and implementing quality management systems. He works in Cambridge, Massachusetts, contributing to the development and commercialization of innovative therapies.
Previous Experience at TESARO, Inc.
Prior to his current role, Jacky Lei worked at TESARO, Inc. as a Senior Manager in Commercial QC from 2016 to 2018. During his tenure in Waltham, MA, he focused on quality control processes within the commercial sector. His experience at TESARO contributed to his expertise in managing quality operations in a fast-paced pharmaceutical environment.
Background in Quality Control at Momenta Pharmaceuticals
Jacky Lei was employed at Momenta Pharmaceuticals as a Quality Control Manager from 2005 to 2016. Over the course of 11 years in Cambridge, MA, he developed skills in quality management and oversight of quality control processes. His long-term commitment to quality assurance in the pharmaceutical industry has shaped his professional trajectory.
Education and Expertise
Jacky Lei holds a Bachelor's degree in Chemistry from The Ohio State University, completed from 1995 to 2000. He furthered his education with a Master's degree in Biotechnology Management from Harvard Extension School, achieved from 2015 to 2020. His academic background supports his extensive experience in quality operations, method validation, and compliance in GLP/GMP environments.
Professional Skills and Specializations
With over 20 years of experience, Jacky Lei specializes in Quality Operations, Method Validation, Change Control, and Quality Management Systems. He is metrics-driven, focusing on improving quality control processes. His expertise also includes vendor management, emphasizing the importance of building partnerships and promoting accountability within the pharmaceutical industry.