Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

Responsibilities

  • 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.

Basic Qualifications:

  • MS/Ph.D. in Analytical Biochemistry / Biotechnology/ Chemistry/Protein Science or related fields.
  • Three (3) or more years for Ph.D and eight (8) or more years for MS 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

 

Primary Location: China – Shanghai

 

To apply please send your application to HR_Biologics@wuxiapptec.com

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