Work Scope:
1. Lead junior scientists to develop liquid chromatography/CE/MS methods for protein therapeutics development in early and late stages, including method development/assessment, qualification/validation and troubleshooting.
2. Work as analytical function leader to support CMC projects, including timeline management; cross-functional support and feedback to facilitate process development; 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.
4. Strong knowledge in CMC and regulatory is preferred.
Qualifications:
1. Requires a Ph.D. in analytical chemistry, biochemistry and 1-5 years of relevant experience that demonstrates an expertise in assay development and scientific accomplishments.
2. Extensive hands-on experience in HPLC/CE/MS technologies. Industrial experience in development and validation of HPLC/CE/MS methods for CMC applications is preferred.
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.