職位描述
Responsibilities:
1.responsible for upstream process technology transfer, engineering scale-up,
2.responsible for process optimization from bench to large scale for a number of production processes using mammalian cell culture technology.
3.lead a group of scientist, associates, technical operators to conduct mammalian cell culture including CHO, HEK293, NS0, and other cell lines in producing monoclonal antibodies, cytokines, IgG fusion proteins.
4.train junior staffs in technical and GMP compliance.
5.The group will accept lab scale process through technology transfer and scale-up the process to production scale with optimization in large scale production.
6.The group will conduct production harvest to support downstream production.
Request:
1.Minimum 5 years biopharmaceutical industrial experiences after Ph.D. training in related fields of biochemical engineering, chemical engineering, biochemistry, cell biology, industrial fermentation, and/or biological sciences. Must have CGMP experiences in biologics.
2.Previous leadership in upstream biological production is appreciated.
3.Previous experiences in international biopharmaceutical industry is a plus.Excellent communication skill both in Chinese and in English is required.
主要職責:
1.負責上游的工藝技術(shù)轉(zhuǎn)移、工程放大;
2.負責使用到脯乳動物細胞培養(yǎng)技術(shù)的工藝優(yōu)化(從實驗室研發(fā)到大規(guī)模生產(chǎn));
3.負責領(lǐng)導(dǎo)團隊(包括:科學家、助理及技術(shù)操作人員等)進行哺乳動物細胞培養(yǎng),包括CHO, HEK293, NS0, 和其它細胞株在生產(chǎn)單克隆抗體、細胞因子及IgG融合蛋白
4.依照GMP的相關(guān)要求及標準對初級員工的進行技術(shù)培訓(xùn)及其他培訓(xùn);
5. 確保團隊通過技術(shù)轉(zhuǎn)移和工程放大接收并熟悉實驗室規(guī)模的操作流程,并實現(xiàn)大規(guī)模生產(chǎn)的工藝優(yōu)化;
6. 帶領(lǐng)團隊進行產(chǎn)品收集,用以支持下游生產(chǎn)的相關(guān)工作;
具體要求:
1. 生物工程、化學工程、生物化學、細胞生物學、工程發(fā)酵等生物相關(guān)專業(yè)博士或同等學歷;需5年以上生物制藥企業(yè)相關(guān)工作經(jīng)歷;
2. 必須具備生物制劑cGMP相關(guān)工作經(jīng)驗;熟知cGMP相關(guān)知識及要求標準;
3. 擁有生物制藥生產(chǎn)上游管理經(jīng)驗者優(yōu)先;擁有國際生物制藥企業(yè)相關(guān)工作經(jīng)驗者優(yōu)先;
4. 具有流利的英語口語和讀寫能力。
企業(yè)介紹
是一家中美合資的生物制藥公司,坐落于天津中新生態(tài)城。公司正在籌建包括研發(fā)、中試、質(zhì)控及GMP生產(chǎn)等功能的大型生產(chǎn)基地,并陸續(xù)從國內(nèi)外招聘優(yōu)秀人才,組建一流的研發(fā)及生產(chǎn)團隊。公司正在籌建的是中國規(guī)模最大之一的生物藥物生產(chǎn)設(shè)施,其研發(fā)、生產(chǎn)及質(zhì)量控制等設(shè)施均達到歐美設(shè)計建造標準。第一期工程將在三年內(nèi)投產(chǎn)運行。杰科生物預(yù)計未來一期、二期共建設(shè)十條生產(chǎn)線,滿足十多個生物藥物的大規(guī)模GMP生產(chǎn),達到1000-1500人的規(guī)模,產(chǎn)品包括單克隆抗體、抗體融合蛋白、細胞因子、重組蛋白或DNA疫苗等。