Tong Zhang

• Manage projects to ensure completion in a timely manner to the satisfaction of clients • Coach junior scientists and other members of the team for chromatographic techniques

Analytical method development on chromatography, electrophorsis on mAB, mRNA and excipients. Perform feasibility and troubleshoot for HPLC methods. Review and evaluate data.

• Work as analytical development lead for early stage development program and collaborate with global analytical development site and achieved multiple development milestones • Accomplished Critical Quality Attribute (CQA) assessment for bio-therapeutic and authored CQA technical reports • Contributed to IND regulatory document and supported regulatory filling studies

• Lead analytical method development and validation projects for Biotherapeutics and impurity analyses to support in-process monitoring and product release • Develop analytical experiments on therapeutic proteins characterization, and analyzes experiential data to elucidate the quality attributes of therapeutic protein candidates and/or products • Author validation protocols, validation reports, development reports, SOPs, quality system documents for supporting regulatory filings and post-marketing commitments • Investigate, evaluate, introduce and implement new technologies in bioanalytical assays and modernize or improve operational efficiencies in QC laboratory

• Responsible for third party activities, including technology transfer analytical methods to CMO labs, and monitoring process validation and supporting PAI • Developed, validated and implemented UPLC method for characterization of Biotherapeutic and monitoring the long term stability of drug substance • Performed HPLC, UPLC, UV-A280, ELISA analyses for supporting clinical and commercial biologic products • Authored validation protocols, validation reports, technical reports and qualify system documents

• Performed protein purification using SEC, IEC and affinity chromatography to study the correlation of salivary enzymes and children’s cavity activities • Functionally and mechanistically characterized of enzymes, protein using multiple protein chemistry approaches to support the study of searching the cause of diseases • Prepared and analyzed proteomic sample to support protein post-translation modification project • Performed cell culture, cell line maintenance, mice immunization and spleen fusion technology to generate monoclonal antibodies for quatitation the salivary protein concentrations and glycosyltransferases in patient samples • Conducted ELISA and Western Blot to screen and identify monoclonal antibodies