Lauren Miyashita serves as the Principal CDMO Site Manager for External Collaborations in Cell and Gene Therapy at Genentech, where she plays a pivotal role in bridging the gap between internal functions and external partners, including Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations...
Lauren Miyashita serves as the Principal CDMO Site Manager for External Collaborations in Cell and Gene Therapy at Genentech, where she plays a pivotal role in bridging the gap between internal functions and external partners, including Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), and Contract Laboratory Organizations (CLOs). With her extensive background in biotechnology and hands-on engineering, Lauren is adept at navigating the complexities of clinical and commercial cell and gene therapy (CGT) products. Her expertise in recombinant protein production, particularly in mammalian cell culture and downstream purification, positions her as a key player in ensuring that Genentech’s innovative therapies are developed and delivered efficiently.
In her current role, Lauren leads cross-functional teams through the entire lifecycle of CDMO and third-party collaborations, from selection and implementation to management and decommissioning. She is committed to upholding the highest standards of compliance, ensuring that all processes align with current Good Manufacturing Practices (cGMP) and regulatory requirements. Her championing of Continuous Improvement methodologies, including LEAN and Design Thinking, reflects her passion for driving process enhancements and fostering talent development within her teams. By leveraging her skills in technology transfer and her deep understanding of FDA regulations, Lauren ensures that the Make-Assess-Release (MAR) process is executed on time, ultimately contributing to the successful launch of groundbreaking therapies that address unmet medical needs. Her leadership not only enhances operational efficiency but also cultivates a culture of innovation and excellence at Genentech.
