Role Summary
WuXi Biologics is seeking an MSAT Drug Product expert to lead high-stakes technology transfers and process validation for drug product manufacturing process. You will drive GMP compliance through risk assessments, PPQ campaigns, and CQA/CPP identification for late-stage global projects. This is a key leadership opportunity to optimize manufacturing processes and manage technical knowledge within a world-class CRDMO.
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 MSAT Drug Product (DP) technology transfer management procedures to ensure GMP compliance.
- 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
- Min 8 - 10 years of relevant experience in manufacturing technology transfer/process development in drug product process (formulation / aseptic filling etc)
- Be familiar with basic knowledge of 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.
