1）Serve as the CMC project leader for antibody drugs.
2）Lead the development of CMC plan and ensure it align with the overall project plan.
3）Maintain effective comminucation 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.
1）PHD or MD preferred.
2）7+ years of technical experience in CMC development and in charged of at least one CMC project foucusing on antibody DRUG.
3）Strong knowlege of US and Chinese CMC regulations and guidelines applicable to oncology drugs including NDA and IND filing requirements.
4）Experience with Clinical-stage CMC development
5）Strong working knowledege of GMP.
6）Experience with CMC technical content for regulatory submission is preferred.
7）Excellent communication skill on both oral and written, both in Chinese and English.
该职位工作地点可选美国（马萨诸塞州）或中国北京
一家做模式动物的公司在美国有分公司，该职位是该公司新成立的抗体研发中心职位，汇报对象老板。老板系华裔，千人计划。
