合创分析项目团队 高级研究员-副主任级别高级研究员

Work Scope:

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; draft relevant CMC sections for regulatory submissions including INDs and BLAs.

2. Deep understanding of liquid chromatography or CE or MS or bioassay methods for protein therapeutics development in early and late stages, including method development/assessment,

/validation and troubleshooting.

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

4. Strong knowledge in CMC and regulatory is preferred.

5.Lead or participate in platform technology/system establishment

Qualifications:

1. Requires a Master and above in analytical chemistry, biochemistry and 1-5 years of relevant experience in industry. PhD is preferred.Fluent in speaking English is a must.

2. Extensive hands-on experience in HPLC/CE/MS technologies. Industrial experience in development or validation of HPLC/CE/MS methods for CMC applications is a plus.

3. Experience with biochemical and physiochemical characterization of protein therapeutics.

4. Records of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journals. 5. Excellent communication skills (both verbal and written) and interpersonal skills are required. Fluent in English and Chinese.

6. Experience interacting with authorities (FDA, EMA, CDS, etc) is preferred

7. Experience in GMP (Good Manufacture Practice) is a plus.