The MSAT Engineer will be the primary owner of the transfer protocol to ensure process developed can be executed flawlessly in the Singapore facility.
Location : Tuas Biomedical Park with company transport provided islandwide
Responsibilities :
- 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 Drug Product manufacturing process.
- Support technology transfer related documentation management.
- Support the investigation of deviations during technology transfer.
Requirements:
- Bachelor's degree or higher in Microbiology, Chemistry, Biotechnology, Biochemistry, Pharmacy, or a related discipline.
- 35 years of experience in manufacturing process improvement or technology transfer within the biopharmaceutical industry.
- Knowledge of drug product formulation, process scaledown/scaleup, and process characterization is an added advantage.
- Solid understanding of aseptic assurance and GMP regulations.
- Familiar with drug product process development and aseptic filling operations.
- A strong team player with excellent organizational and communication abilities.
- Proactive, responsible, disciplined, detailoriented, and focused on achieving results.
