Bruce Ng
Director of Cmc Program Management @Oricell Therapeutics
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WORK HISTORY
Director of Cmc Program Management @Oricell Therapeutics
Lead technology transfer to CMO for GMP clinical manufacturing of OriCAR-017 GPRC5D-targeted CAR-T therapy for multiple myeloma• Completed program tech transfer in 6 months and led to successful IND approval for clinical trial in the US• Managed the authoring of IND with CMC Tech Op, Quality Assurance, and Regulatory Affairs, and coordinated responses to FDA information requests• Lead the cold transport supply chain logistics for patients’ fresh apheresis shipment from clinical sites and Final Drug Product shipment from CMO to clinical sites• Lead CMC support for Clin Op site activations • Coordinate with the Clin Op group with patient enrollment and Final Drug Product production/delivery• Lead a matrixed product development team with interactions with early development, regulatory affairs, quality, supply chain, and CMC tech op functional groups
EDUCATION
Columbia Engineering
Bachelor's of Science, Bio-engineering
SKILLS
ABOUT BRUCE NG
Experienced project leader in drug discovery, translational research, process development, tech transfer and GMP manufacturing of novel cell and gene therapies in biotech, large pharmaceutical companies and CMO. Collaborated with cross-functional teams successfully to implement GMP production for Phase I clinical trials toward commercial productions for multiple cell (CAR-Ts, gene-modified HSCs) and gene therapy (AAV, LVV) Strong team player with demonstrated technical proficiency, scientific creativity and independent thought processes. Established success in peer leadership, project management, cross-franchise/cross-functional collaboration and relationship building.
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