Bio

Molecular and Cellular Scientist with expertise in translational development and manufacture of Cell and Gene Therapy Products for Clinical applications. 20+ years of Research and Development experience in Molecular and Cell Biology, Veterology, Gene Therapy, Immune Gene Therapy for Haemato-oncology; 15+ years GMP manufacture experience for CGT and viral vector products as IMP. Led bench-to-bedside development and regulatory submission of CGT products. Oversaw establishment and manufacture at UK's first GMP viral vector core and led successful clinical and commercial manufacturing campaigns for viral vectors. PIC/S, EMA, US FDA GMP implementation for CGT products. Translational process development and GMP manufacture of a range of immune cell and gene therapy products for oncology and genetic disorders. Analytical development for CGT products. Regulatory audits, accreditation, GMP certification and manufacturing authorisation. Stakeholder and advisor for new facility design, C&Q and IOPQ. Reviewer for CGT product commercialisation and infrastructure build in UK and Singapore. Advisory committee member for national CGT product regulations. Co-founded and established SE Asia's first GMP certified CDMO for Viral Vectors in Singapore.