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.
• Work with HPLC/UPLC, CE, MS techniques for protein therapeutics development in early and late stages, including sample testing, method development, qualification/validation and troubleshooting, and collaboration with partner organizations.
• Draft relevant CMC sections for regulatory submissions including INDs and BLAs.
• Communicate effectively about ideas, project goals and results with cross-functional team members.
• Develop talent, inspire innovation and operational excellence and foster a continuous learning environment.
• Guide scientists in the initiation and execution of laboratory experimentation with the consideration of economic, regulatory and safety factors.

Qualifications:

• M.S. in analytical chemistry or biochemistry or biology or related physical sciences (such as pharmacology, medicine, chemistry) and 2-5 years of relevant experience with proven record in scientific accomplishments and protein assay development.
• Experiences in HPLC, CE, MS, immunoassays technologies, especially in the development and validation of those methods for CMC applications.
• Knowledge and training in chromatography, protein separation, immunoassays and protein characterization.

• Record of technical writing (in English) as demonstrated by peer-reviewed publications in professional journals.

• Excellent communication skills (both verbal and written) and interpersonal skills.
• Self-motivated and organized.

上班地址：富特中路288号