Scientist of Protein Analytical Development (Shanghai/Wuxi , China)
- Report to a director and supervise an analytical group to accomplish HPLC/CE-based (and other as needed) analytical method development, qualification/validation, and transferring.
- As analytical function leader to represent the progress in CMC team for selected projects to serve clients.
- Lead the group to conduct sample analysis to support bioprocess developments, biologics product release and characterization, and stability as well.
- Working with director to hire new talent, train new employees, and maintain the talents for higher working efficiency.
- To ensure compliance to meet regulatory requirements, including instrument maintenance, personnel training, document drafting/reviewing and archiving under ADQC/GMP
- Ph.D. in Analytical Biochemistry / Biotechnology/ Chemistry/Protein Science or related fields with three (3) or more years of working experience in Bio-Pharmaceutical/Biotech industries.
- Solid experience with analytical method development, qualification and/or validation, and method transferring from Lab to Lab, or from Lab to manufacturer; experience with GMP/GLP is preferred.
- With in-depth knowledge with HPLC/UPLC, LC/MS and /or capillary electrophoresis (including CE-SDS, cIEF, CZE and so on), or related technologies.
- Have a good record of supervising and/or management roles.
- Understanding and knowledgeable of regulatory requirements of Biologics by cFDA/FDA/EMEA.
- Excellent speaking and writing communication skills in English