1. Quality Control Management: - Extend QC lab and build its analytical capability for entrusted product (biologics) release testing covering from raw materials, excipients, intermediates (API), and finished goods leveraging current QC capabilities. - Supervise and coordinate quality control activities for CMO (biologics) production. - Implement, and maintain quality control procedures and protocols. - Ensure compliance with GMP, company policies, and regulatory requirements. 2. Team Leadership: - Manage, train, and mentor quality control team members. - Assign tasks, monitor performance, and provide feedback to team members. - Foster a culture of continuous improvement and quality excellence. 3. Technical Expertise: - Oversee and perform complex analytical testing of biologics (e.g. bioassay and function testing, Glycosylation analysis, physicochemical characterization …, etc). - Interpret test results and make decisions on product quality and release. - Troubleshoot and resolve quality-related issues in the production process. 4. Documentation and Reporting: - Ensure accurate and timely documentation of all quality control activities. - Prepare and review batch records, test results, and quality reports. - Maintain up-to-date standard operating procedures (SOPs) for quality control processes. 5. Regulatory Compliance: - Stay informed about relevant regulations and guidelines in the biopharmaceutical industry. - Participate in regulatory inspections and audits. - Contribute to the preparation of regulatory submissions related to quality control. 6. Continuous Improvement: - Identify opportunities for process improvements and cost reductions. - Implement new technologies and methodologies to enhance quality control efficiency. - Collaborate with other departments to optimize production and quality processes.…

• Experience: 工作经验: - Minimum of 5 years of experience in quality control within the biopharmaceutical industry, with at least 2 years in a supervisory role. - In-depth knowledge of GMP regulations and quality control processes for biologics . - Proficiency in quality management systems and relevant software applications. • Soft skill: 通用技能: - Strong analytical and problem-solving skills. - Excellent leadership and communication abilities. • Technical skill: 专业技能: - Proficiency in using HPLC (RP-HPLC, IEX,SEC, …, etc )for identity, purity, impurities of biologics - Expertise in Capillary Electrophoresis (CE) molecular variants and impurities. - Expertise in Cell-Based Assays and functions testing of biologics. - Expertise in data Analysis and Interpretation, i.e. Statistical Analysis of QC data to identify trends and deviations and using QC software and data analysis tools effectively. • Education: 教育背景: - Bachelor's degree in Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related field. Advanced degree (MS or PhD) preferred. • Languages: 语言要求: Proficiency in English, oral and written • Play to Win Behaviors: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi 全力致胜行为: 超越自我, 主动出击, 以患者和客户为本, 团结一致