Understand and comply with company's policies, particular in IP (Intellectual Protection).
Ensure the compliance with EHS requirements in daily work.
Draft 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.
Lead the process validation activities, including change controls, process control strategy, PPQ/supportive study protocols, define and identify CQA/CPPs, be trainers, CPV campaign, comparability study etc.
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. 3 years+ work experience.
Be familiar with basic knowledge of aseptic assurance and GMP regulation. Understand DP process development and aseptic filling. At least three years experience in biopharmaceutical industry, some knowledge of drug product formulation, process scale-down and -up, and process characterization is preferred.
Team player with good organization and communication skills.
Pro-active, high sense of responsibility, self-discipline, focus on details and result oriented.
