The Group Leader of Microbiology of WuXi Vaccines in Suzhou (company) shall be overall responsible for microbial relevant activities. Internally, this position is expected to collaborate with all teams of the company and QC teams of WuXi Biologics. Externally, the group leader shall connect with customers to meet their expectations.


Responsibilities:
1.Lead a group of scientific staff performing environment monitoring for clean areas, and microbial testing including bioburden testing, endotoxin testing and sterility testing and CCIT, 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 microbiological 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 Microbiology or related field.
2.More than 8 years of experiences in QC related fields.
3.More than 5 years’ people management or project experience.
4.Experience with analytical method testing or development in biological macromolecules (biologics) is required.
5.Hands-on experiences in microbial testing are required.