招聘人數:1 | 學歷:博士 | 工作經驗:7年以上
職位描述:
Job Description
1. Serve as the CMC project leader for assigned Drug Products.
2. Lead the process development of monoclonal antibody drugs, technology transfer, pilot amplification, including development planning, management of the entire process of CMC Development, and ensure it align with the overall project plan.
3. Maintain effective communication with internal and external responsible parties.
4. Define all CMC activities required for implementation of the product clinical/commercial plan, ensure alignment with company’s overall business strategy.
5. Develop the Product Definition and CMC Strategy documents with appropriate input from cross-functional team members
6. Monitor and control the CMC process; within budget, and timeline.