工作职责： 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.

任职要求：50-60岁 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.