南京招聘

职位描述：
主要职责：
1、管理上游工艺开发部门的整体工作并确保项目时间进度；
2、领导部门团队开发抗体或重组蛋白产品用细胞培养工艺；
3、优化细胞培养工艺并确保符合中美临床试验申报规范要求；
4、负责实验设计与实验执行，并进行规模放大，对员工进行技术指导；
5、组织实施开发及生产工艺SOP文件编写，确保文件及时准确
6、开发新技术以加速细胞培养进展；
7、负责员工的招聘、激励、培训等并建设强有力的团队。
任职要求：
1、生物类专业背景，博士两年以上或硕士五年以上工业界经验；
2、拥有单抗产品或重组蛋白产品的CHO细胞或其他哺乳动物细胞培养工艺开发经验；
3、拥有生物反应器、培养基等操作开发经验；
4、熟悉细胞培养工艺放大、转移、批记录等相关工作；
5、能良好运用DOE、统计等相关工具改进提高细胞培养工艺；
6、能良好适应交叉学科及快速变化的工作环境；
7、具备独立思考，良好的沟通及解决问题的能力；
8、能熟练使用中英文交流。



Position: Director/ Associate Director of mammalian cell culture process development
Report to: Executive Vice President
Location: Wuhan, Hubei, China

Key Accountabilities:
1、Supervise daily upstream manufacturing activities and ensure production timelines are met.
2、Develop & optimize cell culture processes for IND-enabling projects per China/US/regulatory requirements.
3、Lead a group of scientists and engineers to develop cell culture process for mAbs or recombinant protein production.
4、Responsible for the cell lines of cloning, selection.
5、Design and carry out experiments at bench and pilot scale and provide technical leadership to associates.
6、Contributes to continual improvement of all development documentation (SOP’s) to ensure they are current, accurate, and clear.
7、Explore new technologies to speed up process development for cell culture.
8、Collaborate with other functional groups on the projects such as, cell line development group, downstream purification group, and analytical group, etc.
9、Motivate, retain, develop, train group members and recruit new staffs to build a strong team.

Requirements:
1、PhD with 2+ yrs industry experience or MS with 5+ yrs 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 spin tube, shake flask, and bioreactor is required.
4、Previous experience in cell culture scale-up, tech transfer including drafting development reports, production batch records, 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.
Independent thinking and good communication and problem solving skills.
7、Fluent communication in English and Chinese is a plus. 举报 分享

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