1. Development of unique production process for protein drug from laboratory to production. 2. Process optimization in homogenization, filtration, TFF and column chromatography.3. Assisted in setting specifications of incoming raw materials, intermediates, bulk and final product and monitoring to meet the USP and EP standard. 4. Supported QA in preparing SOPs and Batch Production Record (BPR). 5. Performed production and carried out the in-process tests analysis. 6. Prepared… Show more 1. Development of unique production process for protein drug from laboratory to production. 2. Process optimization in homogenization, filtration, TFF and column chromatography.3. Assisted in setting specifications of incoming raw materials, intermediates, bulk and final product and monitoring to meet the USP and EP standard. 4. Supported QA in preparing SOPs and Batch Production Record (BPR). 5. Performed production and carried out the in-process tests analysis. 6. Prepared Tech Transfer Protocol and worked with CMO in South Korea for the production. 7. Participated in GMP production and successfully produced 3 consecutive batches in 500 L fermentation scale for GLP study.8. Competent in operating the AKTA system with the INdEX & BPG columns. Show less

1. Development of plasmid DNA production process for veterinary vaccine. 2. Executed the production in GMP compliant facilities and performed in-process tests as per SOPs and BPRs. 3. Carried out equipment calibration, routine maintenance, environmental monitoring (air and purified water) 4. Participated in production plants design and performed trial runs (up to 1000 L fermentation) in 3 different production plants.

1. Worked in downstream purification of recombinant protein for clinical trial phase I in liver cancer patients. 2. Set up and carry out purification process in GMP facilities in Mainland China. 3. Participated in setting QC specification for intermediate, semi-final, and final product. 4. Participated in writing and reviewing IND CMC section for new drug application of FDA and China SFDA. 5. Studied on PEGylation process: successfully reduced the cost and improved the process… Show more 1. Worked in downstream purification of recombinant protein for clinical trial phase I in liver cancer patients. 2. Set up and carry out purification process in GMP facilities in Mainland China. 3. Participated in setting QC specification for intermediate, semi-final, and final product. 4. Participated in writing and reviewing IND CMC section for new drug application of FDA and China SFDA. 5. Studied on PEGylation process: successfully reduced the cost and improved the process stability. Show less