闕博士，和鉑醫(yī)藥首席技術(shù)官，負(fù)責(zé)CMC版塊，工藝開(kāi)發(fā)，GMP臨床樣品生產(chǎn)與商業(yè)化生產(chǎn)，推動(dòng)管線項(xiàng)目的研發(fā)與上市。成功領(lǐng)導(dǎo)、參與多個(gè)抗體藥與蛋白藥的開(kāi)發(fā)與上市，在生物藥研發(fā)、CMC 、蛋白分析與特征研究、質(zhì)量體系、質(zhì)量控制、GMP臨床與商業(yè)化生產(chǎn)，技術(shù)平臺(tái)建設(shè)、團(tuán)隊(duì)建設(shè)、項(xiàng)目管理、法規(guī)注冊(cè)方面具有20多年的豐富經(jīng)驗(yàn)。 加入和鉑醫(yī)藥之前，闕紅博士曾任職于美國(guó)輝瑞制藥及基因泰克科學(xué)家與首席科學(xué)家，藥明生物執(zhí)行主任，信達(dá)生物制藥集團(tuán)高級(jí)副總裁。 闕博士獲得美國(guó)印第安納大學(xué)分析化學(xué)博士學(xué)位。 Dr. Que serves as Chief Technology Officer at Harbour BioMed, responsible for CMC development including process development, cGMP manufacturing of antibody therapeutics.? She is specialized at Analytical Development and Quality Control, and She has extensive experience in leading projects through CMC development, IND filing, clinical development, BLA/NDA filing, GMP/PAI inspection towards BLA approval, product launch and commercialization. Previously, Dr. Que worked as Senior VP of Quality for Innovent Biologics, Executive Director of Protein Analytical Science for WuXi Biologics, Genentech and Pfizer Global Biologics in the area of protein analytical chemistry of protein drug development. Dr. Que obtained PhD in Bioanalytical Chemistry from Chemistry Department, Indiana University. |