Responsibilities:

Understand and comply with company's policies, particularly 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 compaign, comparability study etc

Working with cross function teams 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 or any other relevant education.

5 years+ work experience within biopharmaceutical industry

Familiar with aseptic assurance and GMP regulation, understanding Drug Product process development