Yang Gao

Head of CMC Analytical Research & Development (ARD), providing analytical strategy and operational support for all clinical and commercial stage projects, and collaborating with all other CMC functions to form product development strategies

Head of Suzhou Analytical Research & Development (ARD), providing analytical strategy and operational support for all clinical stage projects, and collaborating with all other CMC functions. Head of Advanced Analytical Technology (A2T), providing lifecycle management support for commercial stage product. Lead the efforts in advancing analytical technologies used in the pharmaceutical industry, including but not limited to statistics, simulation, PAT, etc.

Head of Suzhou Analytical Research & Development (ARD), providing analytical strategy and operational support for all clinical stage projects, and collaborating with all other CMC functions. Scope includes method development activities, method development reports, study protocols and reports, specifications, regulatory filings, difficult technical issues and scientific and technical support for investigations, managing external CROs/CMOs on outsourcing activities related to developmental projects.

Pharmaceutical Development: API, BDS, DP analytical development, including method development, validation, transfer, release, stability, control strategy, CR/MO management, investigation, CAPA, DoE, CPV, etc. Regulatory: IND, IMPD, NDA, BLA Technical: LC, GC, Prep-LC, LC-MS/MS, GC-MS, LC-HRMS, SEC, IEX, LBA, ADCC, ADCP, CE-SDS, SPE, PSD, SEM, XRPD, DSC, TGA, IR, UV, etc.

Researches and develops methods for validation assays using a variety of analytical techniques for multidisciplined studies to generate results, solve problems, and interpret data of a scientific nature.

Mass spectrometry application of gaseous bio-ion chemistry under the direction of Professor Scott A. McLuckey. -- Successfully unraveled the gas phase dissociation pattern of heavily modified siRNA using QqTOF mass spectrometer -- Methodology for top-down mitochondria tRNA sequencing -- Methodology for novel top-down proteomics -- Gas-phase covalent chemistry for protein cross-linking and chemical labelling