Jimmy Zhao

Responsibility Executive as a FL or co-member in large molecule CMC, including downstream process development, pilot, tech-transfer and GMP support,drafting related reports for IND filing and prepare sample for customer. Highlights ★As a co-member for a Fc protein IND filing, accounting for 50% performance : conquer the challenge of high HMW and poor stability with final DS purity above 99%. Finish downstream PD (DF, AC, VIN, IEX, NF, UFDF) and report draft, tech-transfer, ENG and GMP run support and VC study, honored “Most Valuable Partner” prize from customer. ★Executive as a FL in a mAb: accomplish tech-transfer with supplementation AC and DF process development, within short timeline, ensure smoothly GMP production. ★Late phase PC study: Evaluate and perform FMEA and AC/CEX process verification study for PPQ and BLA

Responsibility Work as a on-site QA, monitor the key manufacture processes to ensure the process conducted in compliance with SOPs and cGMP guidelines, be responsible for product release audit. Highlights ★Organize investigation of deviations, formulate corrective measures and follow up the execution. Successfully help the technical department identify the root cause of deviations using my strength in product and process.

Responsibility Involved in R&D of three biosimilar projects(mAb, polypeptide and enzyme), and mainly engaged in a polypeptide project from its lab scale research, pilot study to production of submission batches, accounting for 20% performance. Highlights ★Mainly responsible for centrifugation and chromatography process, increased and stabilized the concentration yield from 70% to 90%. ★Solved the problem of protein precipitation by optimizing the buffer of chromatography, optimized the process parameters and solve problems appeared in pilot scale. ★Design and perform DoE studies, draft reports of process development to prepare IND filing.

Routine work encompasses clone construction, expression and purification of protein and virus envelope . Successfully conquered several challenges in optimizing the processes and finally obtain protein with stable and high quality.

大学学习建立了完备的生物科学基础知识。