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1. Lead downstream process development for complexed molecule (e.g. bi-specific antibody, tri-specific antibody, Fab, scFv, IgE) with high throughput method;2. Mainly participate in post clinical process characterization project.

Responsibility: 1. Lead the downstream part of CMC projects2. Lead gap analysis between donor’s and receiver’s, including evaluate the process and material gap with FMEA and mitigate the risk. 3. Lead downstream process development and optimization.4. Lead tech-transfer from lab-scale to 200L and 2000L GMP production, communicate and report to customer the protocol of process development and scale-up.5. Design the process model and process flow diagram for GMP production, plan the material with supply chain(SCO).6. Collaborate with technical writer team to design the batch record and review the batch record.7. Collaborate across different functions, including AD, QC, QA, RA, SCO, engineering to ensure the people, equipment, material, method, environment can meet the GMP requirement and make sure the success of tech-transfer.8. Manage the schedule of process development, tech transfer, and production.9. Develop a training and skill matrix and train the newcomers, including basic purification theory, procedure of performing a project, etc.10. Lead drafting the Standard work guide for the downstream process.11. 6S management.

Mainly responsible for purification of proteins in different scales(3L, 10L and 50L ) in process development, using various chromatography techniques (Affinity, Ion exchange, Hydrophobicity and Steric Exclusion Chromatography) according to different properties of proteins (specificity, charge, hydrophobicity, molecular weight, etc.), to obtain high quality products .Achievements: 1. Completed one downstream process development project (mAb), which have been completed from laboratory small-scale process development to 200L scale-up production and successfully delivered. The project mainly includes deep filtration, affinity, anion, cation, nanofiltration, UF/DF process development. Additionally, I completed process development reports, 200L batch production records, and technology transfer reports. 2. Lead the downstream process development for scFv and the conjugated product i. Design and optimize the downstream process for the original scFv and the conjugated;ii. Optimize the conjugation process to increase the yield for the target conjugated;iii. Update the project progress to customer and project team;iv. Deliver the tech-transfer and process development report.