Responsibilities: 1.Microbiological Quality System • Develop and maintain the microbiological control system for mAb/ADC manufacturing. • Define standards and SOPs for raw materials, environment, critical processes, finished products, and water systems. • Ensure documentation and procedures meet FDA/EMA/GMP expectations. • Review key microbiology documents and drive cross functional compliance. 2.Production Process Control & Troubleshooting • Lead investigations of microbiological deviations across production and utilities. • Use structured problem solving (5Why, Fishbone) to identify root causes and define CAPA. • Optimize microbiological monitoring strategies for core manufacturing steps to ensure process control. 3.Water System & Cleanroom Microbiology • Manage microbiological performance and risk controls for purified water and WFI systems. • Lead environmental monitoring program improvement and disinfection strategy evaluation. • Respond to environmental excursions and maintain the state of the clean environment. 4.Technical Support & Cross Functional Leadership • Serve as microbiology SME supporting R&D, Production, QC, QA, and Engineering. • Provide guidance on microbial risk assessments, contamination prevention, and compliance. • Monitor regulatory updates (GMP, ICH) and deliver site wide microbiology training. 5.Deviation & Change Control • Lead cross functional evaluation of microbiology related deviations and changes. • Oversee risk assessments and control strategy changes, monitoring updates, and disinfectant replacements. • Ensure compliance and product quality through effective deviation and change management.

Qualifications: 1.Education • Master or Ph.D. in Microbiology, Bio-engineering, Biotechnology, Pharmaceutical Engineering, or related field; Overseas experience preferred. 2Industry Experience • 15+ years of microbiology experience in biopharmaceutical manufacturing; multinational experience preferred. • Strong knowledge of biologics process microbiology and contamination control. • Experience with GMP system setup, microbiological validation, and regulatory inspections. 3.Professional Skills • Solid understanding of global microbiology regulations and industry standards. • Strong ability to design practical microbial control systems. • Proficient in data analysis to identify trends and drive improvements. 4.Soft Skills • Strong problem solving, communication and cross functional leadership capabilities. • Ability to work in a fast paced, multi project environment with strong ownership and risk awareness.