Assistant/Associate Director, Stability, Analytical Sciences
- Lead the Stability Group in Analytical Sciences
- Strategic oversight and guide all the stability studies performed in Analytical Sciences
- Provide dynamic forecast of upcoming stability projects to the senior management team for management of resources and workload
- Collaborate with other functions to meet projects timeline and deliverables
- Serve as subject matter expert for all stability matters, Participate and lead any stability investigations
- Lead the stability team and improve stability program management
- Develop talent, inspire innovation and operational excellence and foster a continuous learning environment.
- Draft and review of relevant CMC sections for regulatory submissions including INDs and BLAs.
- The candidate must demonstrate solid working knowledge of biologics development processes
- Project experience of IND filing (Domestic or Global projects)
- Understand the global stability regulatory requirements with knowledge of FDA/EMA/CFDA/ICH regulations and guidance on stability
- Be detail oriented with strong project management, problem-solving, negotiating, interpersonal, and communication skills (both written and oral).
- MS or PhD degree in Analytical Chemistry, Biochemistry or other related life sciences degree and 8+ years of relevant biotechnology industry experiences.
Primary Location: China – Shanghai
To apply please send your application to HR_Biologics@wuxiapptec.com