Shuang Yin

1. Analytical and Quality Control Lead for CMC Projects Led analytical and quality control aspects for CMC projects targeting IND and BLA filing in the US, EU, JP, CN, and AU. Molecules include monoclonal antibodies (mAbs), bispecific antibodies (BsAbs), antibody-drug conjugates (ADCs), and fusion proteins. a. Developed, assessed, transferred, evaluated, and qualified analytical methods for quantity, purity, impurities, potency, and general analyses, including CE, CIEF, SEC, RP-LC, HIC, LC-MS, UV/Vis concentration measurements, and so on. b. Ensured timely delivery of analytical documents (protocols, reports, specifications, RoAs, CoAs) and test results, as well as slide decks for progress updates. c. Acted as a key liaison among clients, project managers, and cross-functional teams from analytical development, process development, formulation development, and manufacturing to facilitate smooth project execution. d. Collected and analyzed client preferences to enhance satisfaction and improve service delivery. 2. Group Leader a. Established standardized workflows with team members to improve efficiency and consistency. b. Designed training programs and set KPI goals for team members. 3. LC-MS SME a. Led LC-MS method development and optimization for biopharmaceutical analysis. b. Troubleshot unknown or unexpected species found in LC-MS and other analytical assays. 4. AS and QC Lab Tour Guide a. Introduce AS and QC department, labs and capabilities to clients. b. Answered client’s questions and followed up on their requests.

1. Research Projects on nano-sized proteins for tumor treatment and viral infection prevention a. Molecular design: primary sequence design and cell line construction. b. Protein production: fermentation in shake flasks and bioreactors, protein purification by chromatography, electrophoresis for purity determination, formulation c. Structural characterizations: CD, FS, DLS, HPSEC-MALLS, TEM, LC-MS/MS, DSC d. In vitro and in vivo assessments: cytotoxicity, flow cytometry, anti-tumor assay, pharmacokinetic study, ELISA, mice immunization, T-cell proliferation assay. e. Molecular Dynamic Simulation: structural stability prediction using Gromacs and Molecular Docking by PyRx to reveal possible mechanisms behind experimental findings. 2. Lab management a. Inventory and waste management b. Instrument maintainance and SOP preparation 3. Tutor a. Designed experiments, and prepared slide decks and tutoring materials in other forms. b. Taught students experiments and theoretical mechanisms.