发布时间:
2022
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11
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24
点击次数:
0
所属职位：
首席技术官
所属公司：
岸迈生物科技（苏州）有限公司
个人简介：
苏建华博士负责岸迈生物的整体 生产运营。苏博士曾在辉瑞(Pfizer)、健赞(Genzyme)和默克(Merck& Co)等全球知名药企工作，拥有20多年的药物研发、制造和CMC运营方面的技术和领导经验。他于2014年回到中国， 最初加入药明生物， 负责技术转让部门。随后加入苏州盛迪亚生物制药担任总经理及上海恒瑞医药抗体研究所所长。 在加入岸迈生物之前，任职杭州浙江华海生物制药有限公司的总经理。苏建华博士在细胞培养、纯化和配方工艺开发和改进、技术转让、验证 、制造和合规运营方面拥有丰富的战略领导经验。 在新药 许可证提交和现有许可证的支持工作， 以及监管检查和响应的生产准备方面具有丰富的CMC专业知识。熟悉美国FDA, 欧盟EMA, 中国 NMPA的GMP要求。苏建华博士在美国西弗吉尼亚大学获得化学工程博士学位， 之前 在北京化工大学获得化学工程硕士学位 和天津大学的学士学位Dr. Jerry Su is responsible for overall manufacturing and CMC operations at EpimAb, bringing in 20 years technical and leadership experience in pharmaceutical R&D, manufacturing, and CMC operations with global and China pharmaceutical companies, including Pfizer, Genzyme, Merck, and Hengrui, as well as COMO Wuxi Biologics. Before joining EpimAb, he was GM of Zhejiang Huahai Biopharmaceuticals Co. in Hangzhou. Dr. Su has broad experience in cell culture, process development, technology transfer, validation, manufacturing and compliance operations, with strong hands-on regulatory experience in new drug license submission as well as post-approval product support dealing with regulatory inspection, response preparation and change management. Jerry Su received his Ph.D. in Chemical Engineering (minor in Statistics) of West Virginia University, MS in Chemical Engineering from Beijing University of Chemical Technology, BS in Chemical Engineering from Tianjin University.