职位描述：
职责描述 1.负责抗体类药物的发酵、制剂等工艺的开发，工艺技术转移、放大生产等； 2.负责工艺开发技术平台的建设与优化； 3.管理生物药工艺开发流程及项目执行，保证项目质量及进度； 3.负责工艺团队的管理与培训等工作，建立高效良好的工作氛围； 4.指导及优化工艺技术方案，解决相关技术难题； 5.指导相关专利和文章的整理和撰写； 6.负责工艺开发及生产相关IND申报资料的撰写； 7.支持项目管理部门完成相关计划及任务； 8.支持研发部门优化生物药开发立项、药效研究等。 Key Responsibilities 1.Supervise daily Process activities and ensure production timelines are met. 2.Develop & optimize processes for IND-enabling projects per China/US/regulatory requirements. 3.Lead a group of scientists and engineers to develop cell line, cell culture, purification process, scale-up , pilot scale productin and formulation for mAbs or recombinant protein production. 4.Design and carry out experiments at bench and pilot scale and provide technical leadership to associates. 5.Contributes to continual improvement of all development documentation (SOP’s) to ensure they are current, accurate, and clear. 6.Explore new technologies to speed up process development. 7.Collaborate with other functional groups on the projects such as, R&D group, and analytical group, etc. 8.Motivate, retain, develop, train group members and recruit new staffs to build a strong team. 任职要求 1.医药、细胞生物学、生物工程、生物化学等相关专业硕士及以上，博士为佳； 2.精通细胞培养、制剂开发、抗体工程等相关领域； 3.3-5年以上抗体药物工艺开发经验，具备1个以上大分子工艺项目经验、3年以上团队管理经验； 4.熟悉使用DOE实验设计工具，熟悉QbD工艺开发理念； 5.熟悉CFDA药品开发的法规，熟悉GMP管理体系； 6.正直诚信，良好的领导力及激励能力； 7.良好的中英文沟通交流能力。 Requirements 1.PhD with 10+ years industry experience or MS with 15+ years industry experience in Biochemical Engineering, Chemical Engineering, Biochemistry or related field. 2.Hands-on experience with CHO and other mammalian cell for mAb or recombinant protein production is required. 3.Hands-on experience in bioreactor purification is required. 4.Previous experience in cell culture scale-up, tech transfer including drafting development reports, protocols etc., is highly desired. 5.Previous experience in process development and optimization using statistical tools is a plus (DOE and data analysis). 6.The ability to succeed in a multidisciplinary, fast changing and diverse team environment. 7.Independent thinking and good communication and problem solving skills. 8.Fluent communication in English and Chinese is a plus. 举报