锦鲤求职岗位描述
Key Responsibilities：理解并遵守公司的政策，尤其是知识产权保护 Understand and comply with company policies, particularly Intellectual Property protection.确保日常工作符合EHS要求 Ensure routine work meets EHS requirements.起草及维护制剂车间技术转移管理程序，以确保GMP合规 Draft and maintain drug product workshop Tech Transfer management procedures to ensure GMP compliance.审核新转移项目的差距分析、风险评估，转移方案以及工艺流程图 Review gap analysis, risk assessment, transfer plan and Process Flow Diagram for new transfer project.负责跨厂区的后期项目的差距分析、风险评估，项目变更以及转移方案 Be responsible for gap analysis, risk assessment, project change and transfer plan of post-project across site.跨部门合作，确定技术转移细节，解决相关问题 Cross-departmental collaboration to identify Tech Transfer details and resolve relevant issues.负责建立和维护技术转移知识平台，支持制剂生产工艺优化 Responsible for establishing and maintaining the Tech Transfer knowledge platform. Supporting Drug Product Manufacturing Process Optimization.支持技术转移相关文档管理，支持技术转移过程中的偏差调查 Supporting Documentation Management for Tech Transfer. Supporting Deviation Investigation during Tech Transfer.Requirements：熟练掌握无菌保障基本知识和GMP法规，了解制剂工艺开发和无菌灌装生产。具有三年及以上生物制药行业从业经验，有制剂处方开发，工艺放大和工艺表征经验者优先 Be familiar with the basic knowledge of sterility assurance and GMP regulations, and understand the drug product process development and aseptic filling production. 3 years or more experience in biopharmaceutical industry, experience in formulation development, process scale-up and process characterization is preferred.有良好的团队合作和沟通能力 Good teamwork and communication skills.熟练掌握英语听说读写 Proficiency in English listening, reading and writing.积极主动，高度责任感，自律意识，注重细节，以结果为导向 Proactive, highly responsible, self-discipline, attention to detail, result-oriented.