Specialist, QC Physicochemical Analysis
Be responsible for drafting and reviewing the SOPs related to the corresponding physical and chemical methods and the operation and maintenance of precision instruments of biological products;
Participate in sample detection and record review to ensure the accuracy and effectiveness of test results;
If necessary, be responsible for the development and validation of methods, drafting and reviewing protocol reports and writing and validating 3Q protocols for related equipment; establishing and validating analytical methods including SEC-HPLC, CEX-HPLC, CE, etc.;
independently conduct the experiment according to the experimental protocol, follow up the experimental process, and timely communication with the collaborators to ensure the accuracy and reliability of the experimental results;
As the responsible person for equipment, be responsible for routine maintenance and PM of equipment. Review of equipment life cycle and track of abnormal events.
Identify the corporate culture of the company and be enterprising and responsible for the job;
Full-time Bachelor degree or above;
Major in pharmaceutical engineering, drug analysis or biotechnology and other related specialties;
Have a relevant background in the research or analysis of biological products, and have a basic knowledge background for protein research is superior;
Be familiar with the detection and analysis techniques of protein drugs, be familiar with or master the purity and concentration analysis techniques such as SEC, CEX, peptide mapping, glycosylation, cIEF, CE-SDS and UV spectrophotometer, and be able to process, integrate and interpret the analysis results;
Understand the guidelines for the development and validation of analytical methods in the Chinese Pharmacopoeia, ICH and others, and have QC experience is preferred;
Be familiar with or master various analytical techniques such as high-performance liquid chromatography and capillary electrophoresis, and have experience in mass spectrometry and protein analysis is preferred;
Have a team spirit, has relevant projects and personnel management experience is preferred;
Good English reading and writing ability, and excellent English speaking is preferred;