锦鲤求职岗位描述
We are seeking a highly experienced and motivated Microbiology Expert to act as the microbiology subject matter expert (SME) in support of the core business, an integrated antibody-drug conjugates (ADC) manufacturer, to manufacture ADC intermediates (including pay-load linker, monoclonal antibodies as well as ADC drug substance and ADC drug products. This role is critical to ensuring the microbiological integrity of the manufacturing processes and plays a key role in supporting GMP compliance and product quality.Job Responsibilities1.Microbiological Quality SystemDevelop 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 & TroubleshootingLead 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 MicrobiologyManage 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 LeadershipServe 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 ControlLead 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.Job Requirements:1.EducationMaster or Ph.D. in Microbiology, Bio-engineering, Biotechnology, Pharmaceutical Engineering, or related field; Overseas experience preferred.2Industry Experience15+ 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 SkillsSolid 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 SkillsStrong problem‑solving, communication and cross‑functional leadership capabilities.Ability to work in a fast‑paced, multi‑project environment with strong ownership and risk awareness.