Discovery

Development

Testing

Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Antibody Drug Conjugates

Technologies & Platforms

Responsibilities

  • 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.

 

Basic Qualifications:

  • 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

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