Principal Engineer, MSAT

Key Responsibilities

• Understand and comply with company’s policies, particular in IP (Intellectual Protection).Ensure the compliance with EHS requirements in daily work.            
• Draft and maintain DP technology transfer management procedures to ensure GMP compliance.
• Review gap analysis, risk assessment, technology transfer protocol and process flow diagram for new transfer project.
• Lead gap analysis, risk assessment, change control and technology transfer protocol for cross-site late stage project.
• Working with the cross functions and determine the details of technology transfer and solve related problems
• Responsible for establishing and maintaining the knowledge platform for technology transfer.
• Support the optimization of DP manufacturing process.
• Support technology transfer related documentation management.          
• Support the investigation of deviations during technology transfer.

Requirements：

• Bachelor degree or above, major in Microbiology, Chemistry, Biotechnology, Biochemistry, Pharmacy or other appropriate education. 
• 5- 8 years’ experience in biopharmaceutical industry, some knowledge of drug product formulation, process scale-down and -up, and process characterization is preferred.       
• Strong knowledge of drug product manufacturing process development and aseptic filling, aseptic assurance and GMP regulation.
• Team player with good organization and communication skills.
• Pro-active, high sense of responsibility, self-discipline, focus on details and result oriented.