杭州招聘

Assistant/Associate Director, Stability, Analytical Sciences

WuXi Biologics in Shanghai

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.

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.

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