The Head of Physicochemistry and Biochemistry Testing of WuXi Vaccines in Suzhou (company) shall be overall responsible for separation-related testing activities. Internally, this position is expected to collaborate with all teams of the company and QC teams of WuXi Biologics. Externally, the Head shall connect with customers to meet their expectations.


Responsibilities:
1. Lead a group of scientific staff performing separation testing, including HPLC, SDS-PAGE, CE, iCIEF, and PCR, to support biopharmaceutical product manufacturing and release
2. Lead investigations in response to OOS, OOL, contamination investigations, and adverse trends
3.Provide Quality Control review and approval of Policies, Operational Standards, SOPs, validation protocols and reports
4. Work collaboratively across organization and sites for separation related verification/validation/investigation to meet organizational goals
5. Be responsible for direct supervision of scientific staff, and strong collaboration with partner organizations
6. Draft and review regulatory submissions including INDs and BLAs
7. Develop young staff, inspire innovation and operational excellence and foster a continuous learning environment;
8.Communicate ideas, project goals and results to cross-functional team members;
9.Guarantee GMP compliance and data integrity;
10.Direct scientists in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.


Qualification:
1.Master or above in chemistry, biology or related field.
2.More than 5 years of experiences in QC related fields.
3.More than 3 years’ people management or project leading experience.
4.More than 5 years of experiences in biopharmaceutical industry is preferred.
5.Experience with analytical method testing or development in biological macromolecules (biologics) is required.
6.Hands-on experiences in separation testing are required.