蘇建華博士負(fù)責(zé)岸邁生物的整體 生產(chǎn)運(yùn)營(yíng)。蘇博士曾在輝瑞(Pfizer)、健贊(Genzyme)和默克(Merck& Co)等全球知名
藥企工作，擁有20多年的藥物研發(fā)、制造和CMC運(yùn)營(yíng)方面的技術(shù)和領(lǐng)導(dǎo)經(jīng)驗(yàn)。他于2014年回到中國(guó)， 最初加入藥明
生物， 負(fù)責(zé)技術(shù)轉(zhuǎn)讓部門。隨后加入蘇州盛迪亞生物制藥擔(dān)任總經(jīng)理及上海恒瑞醫(yī)藥抗體研究所所長(zhǎng)。 在加入岸邁生物
之前，任職杭州浙江華海生物制藥有限公司的總經(jīng)理。蘇建華博士在細(xì)胞培養(yǎng)、純化和配方工藝開發(fā)和改進(jìn)、技術(shù)轉(zhuǎn)讓、
驗(yàn)證 、制造和合規(guī)運(yùn)營(yíng)方面擁有豐富的戰(zhàn)略領(lǐng)導(dǎo)經(jīng)驗(yàn)。 在新藥 許可證提交和現(xiàn)有許可證的支持工作， 以及監(jiān)管檢查和響
應(yīng)的生產(chǎn)準(zhǔn)備方面具有豐富的CMC專業(yè)知識(shí)。熟悉美國(guó)FDA, 歐盟EMA, 中國(guó) NMPA的GMP要求。蘇建華博士在
美國(guó)西弗吉尼亞大學(xué)獲得化學(xué)工程博士學(xué)位， 之前 在北京化工大學(xué)獲得化學(xué)工程碩士學(xué)位 和天津大學(xué)的學(xué)士學(xué)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.