• Lead/develop upstream processes for novel pipeline products and monoclonal antibodies for research and development efforts

• Timely execution of all aspects of upstream mammalian cell culture operations

• Lead/perform process optimization and validation based on design of experiment approaches of upstream processes for existing clinical products in preparation for Phase 3/commercial manufacturing

• Compile data to support/contribute to technical/development reports for technology transfer and regulatory submission

• Support technology transfer to contract manufacturing organizations

• Manage/coordinate Cell Culture Development resources and strategic planning to support early and late stage projects.

• Coordinate and collaborate with Discovery and other CMC functions and develop strategies to meet project as well as corporate timelines

• Develop and perform analytical methods on cell culture media to support process development

• Support troubleshooting of technical issues and process improvement for higher efficiency

• Maintain scientific excellence and attention to detail

• Design and conduct experiments, collect and analyze data, write development reports

• Drive innovation through deep understanding of new technologies and methods in cell culture development

• Contribute to the IND filings

Requirements:

1. BS/BA or MS or PhD in Chemical Engineering, Biotechnology, Cell Biology, Molecular Biology, Biochemistry or related field. Number of years of industry experience commensurate with job titles

2. Hands-on experience in mammalian cell culture techniques

3. Experience in cell culture process development for monoclonal antibodies, bispecific antibodies, Fc-fusions and other therapeutic proteins

4. Versatile in techniques in cell expansion and fed-batch/perfusion methodologies, assembly, sterilization, calibration, operation and control of small scale single use and glass bioreactors, analysis of cell growth, metabolic activity and productivity and methods for harvest clarification

5. Exceptionally strong communication and problem solving skills

6. Knowledge of Design of Experiment approaches for process optimization

7. Ability to work independently and multitask in a fast-paced environment

8. Responsible, organized and disciplined record keeping

9. Self-motivated, collaborative, and effective communication skill

上班地址：上海张江哈雷路866号