TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company
Transcenta, Biologics, Antibody, Claudin 18.2
Upstream cell culture of the bulk is performed, including but not limited to the following manufacturing activities: media preparation, cell line recovery, shake flask inoculation, WAVE reactor operation, XDR bioreactor operation, and continuous flow centrifuge operation.
Preparation before upstream cell culture production of stock solution, process scale-up and clinical batch production is performed in the newly built production workshop.
Be responsible for process monitoring, including real-time review of process parameters and process data/trending.
Ensure that the production operation of the stock solution complies with quality and safety regulations.
Participate in the investigation and change control to ensure that the change is of added value and that the process and equipment are stable after the change.
Participate in technological innovation and continuous improvement, active leadership change can improve the accuracy rate, production efficiency and cost reduction.
Prepare the relevant documents, such as production batch record, SOP and validation report.
Provide audit support.
Perform other tasks assigned by the supervisor.
Bachelor degree or above in pharmacy, chemical industry, biology, biochemistry and other related specialties, 3-6 years of experience in cell culture-related work;
Good English speaking and writing skills;
Be familiar with mammalian cell culture, solution preparation, and GMP production;
Be familiar with industrial-scale bioreactors and continuous centrifuges;
Have Experiences in 6 Sigma and 5S management is preferred;
Be familiar with enterprise management systems, such as LabWare LIMS, SAP, TrackWise, PDOCS and EAMS.