Associate Director/Director of Protein Analytical Sciences
- 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,
- 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