Discovery

Development

Testing

Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Antibody Drug Conjugates

Technologies & Platforms

Responsibilities

  • Overseeing the development, qualification and validation of analytical test methods and technology transfer, in accordance with ICH guidance document.
  • Setting strategy for evaluating and implementing new technologies within the Analytical Development department, with a particular emphasis on state of the art separation techniques (HPLC/UPLC and CE) and automation.
  • Providing strong scientific mentorship to direct reports who have both managerial and CMC analytical project leadership roles that support process development, specification setting, and CMC regulatory filings and responses.
  • Designing and adapting analytical paradigms based on the QTPP/CQAs, process control strategies and emerging industry trends
  • Takes a leading role in setting WuXi Biologics company-wide strategic analytical initiatives, including authoring guidance documents,

Basic Qualifications:

  • PhD in a biochemistry, biophysics, or chemistry-related field
  • 8+ years of experience in Analytical Development, with a minimum of 3+ years of managerial experience
  • Expertise in separations science (HPLC, UPLC, capillary electrophoresis), as well as a strong understanding of protein and carbohydrate chemistry
  • Experience leading teams in the development, qualification/validation and transfer of analytical methods
  • Experience writing regulatory submissions, audits and meetings
  • Experience in planning and implementing analytical and CMC strategy for the development of large molecule biologics or gene therapy.
  • Understanding of how QTPP, CQAs and process control strategies are related
  • Excellent oral and written communication skills, who is self-motivated

 

Primary Location: China –Wuxi

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

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