Maoli Yuan serves as the Associate Director of GMP Quality Assurance at IAVI, where she leverages over 15 years of extensive experience in the viral vector-based vaccine field. Her expertise spans the entire continuum of vaccine development, from discovery through early clinical phases, with a...
Maoli Yuan serves as the Associate Director of GMP Quality Assurance at IAVI, where she leverages over 15 years of extensive experience in the viral vector-based vaccine field. Her expertise spans the entire continuum of vaccine development, from discovery through early clinical phases, with a particular focus on establishing robust viral vector delivery platforms. These platforms have been instrumental in advancing vaccine candidates targeting emergent infectious diseases, successfully progressing to Phase I and pre-clinical studies.
In her current role, Maoli is pivotal in ensuring that all quality assurance (QA) processes align with Good Manufacturing Practices (GMP) standards. She provides critical QA guidance and support across various departments and functional units, facilitating seamless collaboration on cross-functional projects. Her responsibilities include reviewing and approving essential documentation such as master batch records, executed batch records, specifications, sampling plans, and Certificates of Analysis (CoAs). By representing QA in interactions with Contract Development and Manufacturing Organizations (CDMOs), she ensures that manufacturing processes meet regulatory requirements and maintain the highest quality standards.
Maoli's technical skills are complemented by her proficiency in industry-standard tools and methodologies, including Veeva Vault for document management, DNA sequencing techniques, and advanced analytical assays. Her hands-on experience with viral vector production, purification, and stable transfection positions her as a key contributor to the development of innovative vaccines. As a leader in the field, Maoli Yuan is dedicated to advancing the science of vaccine development, ensuring that IAVI remains at the forefront of combating infectious diseases through rigorous quality assurance practices.
