Claudia Lin, Ph.D.

Claudia Lin, Ph.D.

Executive Vice President
Pharmatech Associates – a USP company
Cell & Gene Therapy Review Editorial Advisory Board Member

Claudia Lin is a biotech veteran with over 30 years of experience in multi-national companies and startups in the U.S., EU and China working in life cycle biologics product development, manufacturing, and quality. A global supply chain expert, Claudia’s work focuses on phase-appropriate product development, quality management, and regulatory compliance for all biologics. She holds a PhD in cell and molecular biology from the University of California, Berkeley.

Articles by Claudia Lin, Ph.D.

  • A standardized approach to CGT quality management

    Wednesday, March 05, 2025
    This article describes the thought processes involved in defining control strategies across important areas including aseptic control, material control, process control, quality control and chain of custody control. We offer examples of how each of these elements should be developed and documented and discuss the connection of control strategy with quality control and quality systems.