Yan Zhi serves as the Director, Cell & Gene Therapy Product Owner at CSL Behring, where he plays a pivotal role in the life cycle management and commercial launch of AAV-based gene therapy products. With a wealth of experience in the biotech industry, Yan has...
Yan Zhi serves as the Director, Cell & Gene Therapy Product Owner at CSL Behring, where he plays a pivotal role in the life cycle management and commercial launch of AAV-based gene therapy products. With a wealth of experience in the biotech industry, Yan has successfully navigated the complexities of analytical development, ensuring that viral vector-based gene therapies meet rigorous clinical standards. His expertise in cGMP manufacturing at a global Contract Development and Manufacturing Organization (CDMO) has equipped him with the skills necessary to oversee the technical management of technology transfers to both CDMOs and Contract Research Organizations (CROs).
In his current role, Yan is the CMC lead for global regulatory submissions, a responsibility that requires a deep understanding of compliance and quality assurance protocols. His strategic approach to biosafety testing and assay development, including ELISA methodologies, ensures that products not only meet regulatory requirements but also maintain the highest standards of safety and efficacy. Yan collaborates closely with Subject Matter Experts (SMEs) across various disciplines to drive innovation and optimize processes, ultimately enhancing the commercial viability of gene therapy products.
His diverse skill set, which encompasses drug discovery, molecular biology, and Good Laboratory Practice (GLP), positions him as a key player in advancing CSL Behring’s mission to deliver transformative therapies to patients. Through his leadership, Yan Zhi is not only contributing to the successful launch of groundbreaking therapies but also shaping the future landscape of gene therapy within the biotechnology sector.
