分析项目管理高级研究员

Key Responsibilities

1、Work as analytical function leader to support for full-life-cycle CMC projects, including providing analytical strategy based on the understanding of complex molecule; timeline management; batch release/stability support; cross-functional support and feedback to facilitate process development;

2、Draft relevant CMC sections for regulatory submissions including INDs and BLAs.

3、The candidate should be an effective communicator of ideas, project goals and results to cross-functional team members and/or clients in both Chinese and English.

4、Lead or participate in platform technology/system establishment.

5、Willing to collaborate in a team, proactive in learning, and supportive in helping others.

Qualifications

Education

1、Major in Analytical Chemistry, Biochemistry,

2、Pharmaceutical Sciences, Bioengineering, Protein Science, or a related discipline.

Technical Expertise

1、Strong understanding of protein therapeutics, including molecular structure, heterogeneity, and critical quality attributes (CQAs).

2、Demonstrated ability to independently design and execute scientific research projects.

3、Experience with any of the following analytical techniques for protein therapeutics: LC/Capillary/MS technologies, potency analysis, biochemical characterization, or physicochemical characterization.

Communication & Leadership

1、Strong analytical thinking and ability to solve complex scientific and technical problems.

2、Excellent communication and collaboration skills in a multidisciplinary environment.

3、Excellent verbal and written English skills, with the ability to directly interact with global clients in technical discussions, project meetings, and scientific presentations.

4、Ability to clearly communicate scientific concepts, defend technical positions, and influence decisions in an international setting.

5、Self-motivated, innovative, and eager to learn new technologies.

Keywords: Biologics Analytical

Development | Analytical Science | Platform Innovation | Technical Leadership |

Complex Biologics Characterization | Project management