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(zé):
1.負(fù)責(zé)上游的工藝技術(shù)轉(zhuǎn)移、工程放大;
2.負(fù)責(zé)使用到脯乳動(dòng)物細(xì)胞培養(yǎng)技術(shù)的工藝優(yōu)化(從實(shí)驗(yàn)室研發(fā)到大規(guī)模生產(chǎn));
3.負(fù)責(zé)領(lǐng)導(dǎo)團(tuán)隊(duì)(包括:科學(xué)家、助理及技術(shù)操作人員等)進(jìn)行哺乳動(dòng)物細(xì)胞培養(yǎng),包括CHO, HEK293, NS0, 和其它細(xì)胞株在生產(chǎn)單克隆抗體、細(xì)胞因子及IgG融合蛋白
4.依照GMP的相關(guān)要求及標(biāo)準(zhǔn)對(duì)初級(jí)員工的進(jìn)行技術(shù)培訓(xùn)及其他培訓(xùn);
5. 確保團(tuán)隊(duì)通過(guò)技術(shù)轉(zhuǎn)移和工程放大接收并熟悉實(shí)驗(yàn)室規(guī)模的操作流程,并實(shí)現(xiàn)大規(guī)模生產(chǎn)的工藝優(yōu)化;
6. 帶領(lǐng)團(tuán)隊(duì)進(jìn)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(xué)工程、生物化學(xué)、細(xì)胞生物學(xué)、工程發(fā)酵等生物相關(guān)專業(yè)博士或同等學(xué)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(yàn);熟知cGMP相關(guān)知識(shí)及要求標(biāo)準(zhǔn);
3. 擁有生物制藥生產(chǎn)上游管理經(jīng)驗(yàn)者優(yōu)先;擁有國(guó)際生物制藥企業(yè)相關(guān)工作經(jīng)驗(yàn)者優(yōu)先;
4. 具有流利的英語(yǔ)口語(yǔ)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(guó)內(nèi)外招聘優(yōu)秀人才,組建一流的研發(fā)及生產(chǎn)團(tuán)隊(duì)。公司正在籌建的是中國(guó)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(dá)到歐美設(shè)計(jì)建造標(biāo)準(zhǔn)。第一期工程將在三年內(nèi)投產(chǎn)運(yùn)行。杰科生物預(yù)計(jì)未來(lái)一期、二期共建設(shè)十條生產(chǎn)線,滿足十多個(gè)生物藥物的大規(guī)模GMP生產(chǎn),達(dá)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(xì)胞因子、重組蛋白或DNA疫苗等。