Establish and manage DP MSAT lab related activities to build and maintain existed platform. Experiment design, and participate in the MSAT lab activities to support DP manufacturing. Procure lab related materials and equipment. Draft and review lab related SOPs. Maintain lab related operations to make sure that the lab is functional. Monitor the ongoing experiment and compile the data. Draft and review the lab study protocol and report.
PD work
Familiar with the DP process development and PC study, PPQ of biological and vaccines.
Tech Transfer
Participate in external and internal cross-functional meetings. Provide process facility fit evaluation. Participate in the process gap analysis and risk assessment. Compile TT related docs. Participate in the investigation of process related deviations and impact assessment.
Manufacturing Support – DP focus
Support DP GMP manufacturing for process implementation and other necessary support. Participate in the process scale-up, scale-down, trouble shooting and investigation.
2.Education level + professional requirements
Bachelor or Master in life science, Pharmaceutical Engineering, Biochemical Engineering or equivalent. English knowledge in speaking, reading, and writing.
3.Work experience (years / professional experience / industry experience / management experience)
More than 2 years’ working experience in MSAT, DP related PD or Manufacturing experiences in a GMP environment. Tech Transfer related experiences, and Lyophilization injectable related experience is a plus.
