Primary Function:
The successful candidate is expected to take a leadership role to manage and lead the company’s CMC (Small Molecule and Biologics) development and manufacture functions. In this role, the candidate will be responsible for setting the company’s CMC development strategies from early development projects to commercialization products in the context of company’s pipeline growth. The activities will include but not limited to process/formulation development, scale-up, technology transfer, process validation/verification, IND/BLA/MAA CMC filing section preparation, manufacturing tech transfer, CDMO vendor selection, etc. The candidate will be required to spend sufficient working time in China. He/she may be taking the lead to set CMC regulatory strategies for company’s portfolio per requirement.
Major Responsibilities and Duties:
Qualifications:
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