This position is for Suzhou WuXi Vaccines.( 苏州药明海德） JOB RESPONSIBILITY · MSAT DS lab · Establish and manage of new DS MSAT lab related with downstream activities. · Lead and participate the MSAT lab activities for downstream to support DS manufacture · Draft and review the study protocol and report · Tech Transfer – DSP focus · Participate in the external and internal cross-functional meetings · Provide process facility fit evaluation for DSP · Perform the risk assessment for new product introduction (NPI) related with DSP · Lead process gap analysis and risk assessment for DSP · Compile TT related docs for downstream · Lead the investigation of process related deviations and impact assessment · Process Validation – DSP focus · Responsible for write and review process validation master plan · Lead, prepare and perform process performance qualification activities including preparation of protocol and report · Manufacturing Support – DSP focus · Support DS GMP manufacturing for process implementation and other necessary support · Lead process scale-up, scale-down, trouble shooting and investigation · Other work assigned by line manager Minimum Requirement · Education background/ Experience 1) Master’s or Ph.D. in life science, microbiology, biochemical engineering or equivalent 2) Excellent knowledge of English in speaking, reading, and writing · Other requirements 1) More than 5 years of working experience in a GMP manufacturing DS environment on shopfloor and/or MSAT for downstream; vaccine experience is a plus 2) Self-motivated, service-orientated team player 3) Regulatory knowledge/experiences with audit by FDA, EMA, WHO, NMPA etc 4) Demonstrated skills in problem-solving and investigation 5) Effective communication and good interpersonal skills 6) Ability to collaborate and deliver through teamwork 7) Able to effectively perform multiple tasks in a busy environm*******************