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 development, with the experience of BLA or cell and gene therapy industry preferred.
• Be familiar with QbD, GMP and other related regulations/guidance.
• Have good statistical analysis capacity.
• Good command of English and fluent oral English.