Major responsibilities
Engage in tech transfer business, such as preparation of TTP, gap analysis, knowledge transfer and training, to proceed the project as schedule.Ensure the integrality of process materials and timely update as required.Conduct the process related investigation, optimization and scale-up study.Handle the tech related troubleshooting, deviations, change and CAPA during manufacture business.Participate in the related validation studies, including chromatography resin, reusable filter member lifetime validation, mixing study, cleaning study and yield study et al.Attend in GMP audits, regulatory filing as required.Education, Qualifications, Skills and Experience
Master’s degree or above on biological or pharmaceutical relevant major. Graduates from 211/985 Project universities and those with overseas work experience are preferred.More than 3 years’ experience in MSAT or process devel...