Major Responsibilities and Duties:

• Act as CMC lead to manage integrated IND enabling projects outsourced to CDMO, be responsible for overall CMC budget, timeline, deliverable and IND filing, 1-2 projects annually.

• Act as function lead to manage functional activities of CMC development at CDMO site, multiple projects in parallel, including experimental designing, report reviewing, on-site support, dossier writing etc.

• Coordinate internal and external communications for in-licensed and out-licensed projects.

• Support other functions for IND application.

• Continuously screen and select suitable CDMOs for outsourced projects.
  

Qualifications:

• Master’s degree and above for biotechnology, cellular biology, molecular biology and other related subjects.

• More than five-year experience in bioprocessing development for antibody and recombinant proteins.

• Extensive knowledge and experience in the development of biopharmaceutical products,
  including IND as well as regulatory affairs and requirements (both China and US).

• Good communication skills.

• Teamwork spirit.

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