Engage in tech transfer business, such as preparation of TTP, gap analysis, knowledge transfer and training, to proceed the project as schedule
Job Summary
Engage in tech transfer business, such as preparation of TTP, gap analysis, knowledge transfer and training, to proceed the project as schedule.
Participate in 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.
Matching Summary
Engage in tech transfer business, such as preparation of TTP, gap analysis, knowledge transfer and training, to proceed the project as schedule.
Skills & Requirements
Must-have
Tech transfer business
Process investigation and scale-up
GMP compliance
Statistical analysis capacity
Process troubleshooting and CAPA
Validation studies participation
Fluent oral English
Nice-to-have
Experience with BLA or cell and gene therapy
Knowledge of QbD principles
Overseas work experience
Graduates from 211/985 Project universities
Good command of English
Key Requirements
Master’s degree or above in biological or pharmaceutical major
More than 3 years’ experience in MSAT or process development
Familiarity with GMP and related regulations
Experience in BLA or cell and gene therapy preferred