Lead, develop, optimize, scale-down and scale-up cell culture and bioreactor processes in a robust and economically viable way, including evaluating different cell culture media, feed formulations, and feeding strategies to improve product yield, quality and purity.
Generate, manage, interpret, and maintain critical data in a highly organized manner; write and present technical reports to management.
Perform and analyze Design of Experiment (DOE) studies to fully characterize processes. Support process validation studies and activities.
Participate in the technology transfer of bioprocesses internally and externally. The work will involve working with commercial and clinical production facilities to ensure accurate technology transfer and successful large-scale production.
Lead/participate in instrument purchasing and equipment maintenance for process development labs.
Coach and develop direct reports to execute all process development activities to meet aggressive timelines.
Provide input on the evaluations of CMO/CROs.
Collaborate and coordinate with colleagues from R&D, CMC, and quality teams.资历
PhD with 4+ years related experience, MS with 6+ years related experience or BS with 8+ years of related experience.
Solid scientific background in cell culture, molecular biology, and cell biology.
Must have strong analytical skills and upstream experience of cell culture and bioreactor processes development for biologics production.
Extensive knowledge in process optimization, scale-down, scale-up, and technology transfer to the cGMP manufacturing facilities.
Hands-on experience with viral vector, vaccine, cell and gene therapy products is preferred.
Experience in process development and optimization using statistical tools is (DOE and data analysis) is desirable.
Knowledge of process characterization and process validation of biological products is a plus.
Excellent communication and project management skills to work in a multidisciplinary team and manage CMO to meet aggressive timelines.
Fluent in English and Chinese.
This position is based in Shanghai and may require up to 10% domestic or international travel.
中国-上海-上海-Building A, Xinyan Mansion, No. 65, Guiqing Rd., Xuhui District, Shanghai其他地点