Assistant Director/Associate Director/Director of AST
- Lead QC functional group(s) to perform analytical method development/ optimization, qualification/validation, and QC testing under cGMP.
- Schedule resources, coordinate laboratory activities, improve data and document quality to regulatory requirements/expectations.
- Author, review and approve technical documents such as SOPs, methods, protocols, reports, etc.
- Provide technical leadership for problem solving and laboratory investigations.
- Enhance current service offering and develop new capabilities
- Communicate with other functional areas and clients to ensure timely completion of QC activities to meet project timeline.
- Interact with regulatory CMC group to support IND and BLA filing.
- Graduate degree in analytical chemistry, biochemistry, molecular/cell biology, immunology, microbiology or related fields.
- Experience in Pharmaceutical/Biopharmaceutical industry and team management experience are highly desirable.
- Extensive knowledge and hands-on experience in one of the following areas are required.
- Biochemical assays such as ELISA, cell based assay, qPCR, gel electrophoresis, Western blot, enzyme activity testing
- Instrumental analysis such as HPLC, CE, Ion-chromatography, Mass Spectrometry
- Strong oral and writing communication skills in both English and Chinese are required.
- Knowledge in FDA/EMA cGMP regulations, Pharmacopoeias, and ICH guidelines is preferred.
Department: Quality Control
Primary Location: Wuxi, China
To apply please send your application to HR_Biologics@wuxiapptec.com.