Msat Senior Engineer, Dp

Responsibilities ： · Understand and comply with company’s policies,particular in IP (Intellectual Protection). · Ensure the compliance with EHS requirements indaily work. · Draft gap analysis, risk assessment, technologytransfer protocol and process flow diagram for new transfer project. · Lead gap analysis, risk assessment, changecontrol and technology transfer protocol for cross-site late stage project. · Lead the process validation activities, includingchange controls, process control strategy, PPQ/supportive study protocols, defineand identify CQA/CPPs, be trainers, CPV campaign, comparability study etc. · Working with the cross functions and determinethe details of technology transfer and solve related problems · Responsible for establishing and maintaining theknowledge platform for technology transfer. · Support the optimization of DP manufacturingprocess. · Support technology transfer relateddocumentation management. · Support the investigation of deviations duringtechnology transfer. Requirements： · Bachelor degree or above, major in Microbiology,Chemistry, Biotechnology, Biochemistry, Pharmacy or other appropriateeducation. 5 years+ work experience. · Be familiar with basic knowledge of asepticassurance and GMP regulation. Understand DP process development and asepticfilling. At least three years’ experience in biopharmaceutical industry, someknowledge of drug product formulation, process scale-down and -up, and processcharacterization is preferred. · Team player with good organization andcommunication skills. · Pro-active, high sense of responsibility,self-discipline, focus on details and result oriented.