Responsibilities:

• Work in the integrated modular lab including cell culture, purification and protein analysis for mammalian cell culture and purification process development and optimization, scaling up and technology transfer, assay development and qualification/validation, to meet the requirement on quality analysis of drug discovery, development, clinical or commercialization stage.
• Lead junior scientists to develop HPLC/UPLC, CE, MS methods for the development of protein therapeutics for early and late stage programs, including method development, qualification/validation, troubleshooting, and collaboration with partner organizations.
• Develop talent, inspire innovation and operational excellence and foster a continuous learning environment.
• Draft and review of relevant CMC sections for regulatory submissions including INDs and BLAs.
• Communicate effectively about ideas, project goals and results with cross-functional team members.
• Guide scientists in the initiation and execution of laboratory experimentation with the consideration of economic, regulatory and safety factors.

Qualifications:

• Ph.D. in analytical chemistry or biochemistry with 0-5 years of relevant experiences in protein assay development.
• Extensive hands-on experiences in HPLC, CE, MS technologies, including industrial experience in the development and validation of HPLC, CE, and MS methods for CMC applications.
• Experiences in biochemical and physicochemical characterization of protein therapeutics.
• Proven technical writing skills demonstrated by peer-reviewed publications in professional journals.
• Excellent communication skills (both verbal and written) and interpersonal skills. Fluent in English and Chinese. Self-motivated and organized.

In-depth knowledge of GMPs and experience in interacting with health authorities (FDA, EMA, CDE etc.) are advantageous.

上班地址：富特中路288号