Discovery

Development

Testing

Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Antibody Drug Conjugates

Technologies & Platforms

KEY ACCOUNTABILITY:

  • 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.

REQUIREMENTS

  • 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.

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