Assist in or take charge of the management and guidance of partial CMC projects; track project progress, coordinate resources, and ensure the achievement of key milestones.
Handle daily CMC affairs, including internal and external communication, project document management, project meeting organization, contract negotiation, etc.
Identify and resolve risks during project advancement, and support the smooth progress of R&D at all stages.
Complete other related tasks assigned by superiors.
Bachelor's degree or above from a unified recruitment, majoring in Biology, Pharmacy or other related disciplines.
Over 5 years of work experience in process development, analysis or other related fields; experience in CDMO management is preferred.
Familiar with new drug registration regulations; candidates with experience in US, EU and China IND/NDA applications for biologics are preferred.
Possess the ability to compile registration documents, and proficient in using office software.
Have excellent communication skills and teamwork capabilities, with a strong sense of team spirit.