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.