合创分析部高级研究员~副主任级高级研究员

Work Scope:

• 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.
• Deep understanding of liquid chromatography or CE or MS methods for protein therapeutics development in early and late stages, including method development/assessment, qualification/validation and troubleshooting.
• The candidate should be an effective communicator of ideas, project goals and results to cross-functional team members and/or clients.
• Strong knowledge in CMC and regulatory is preferred.
• Lead or participate in platform technology/system establishment

Qualifications:

• Requires a Master and above in analytical chemistry, biochemistry and 1-5 years of relevant experience in industry. Oversea PhD (with working experience) is preferred. Fluent in speaking English is a must.
• 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.
• Experience with biochemical and physiochemical characterization of protein therapeutics.
• Records of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journals.
• Excellent communication skills (both verbal and written) and interpersonal skills are required. Fluent in English and Chinese.
• Experience interacting with authorities (FDA, EMA, CDS, etc) is preferred
• Experience in GMP (Good Manufacture Practice) is a plus.