Job Responsibilities 工作職責(zé)：
1.Responsible for process development of purification (mAb, BsAb, etc), including but not limited to chromatography, filtration, UFDF, stability studies, etc.
負(fù)責(zé)純化（單抗，雙抗等）的工藝開發(fā)，包括但不限于層析、過濾、超濾透析、穩(wěn)定性研究等；
2.Conduct process development and process optimization experiment, including resin screening, filter sizing, buffer sizing, DOE, etc.
執(zhí)行工藝開發(fā)和工藝優(yōu)化實(shí)驗(yàn)，包括填料篩選，濾器選型，緩沖液篩選, DOE等；
3.Responsible for managing technical documents including operating procedures, protocols, reports, risk assessments, laboratory investigations, etc.
負(fù)責(zé)管理技術(shù)文件包括操作規(guī)程，方案，報(bào)告，風(fēng)險(xiǎn)評(píng)估，實(shí)驗(yàn)室調(diào)查等；
4.Responsible for data analysis, data review and trend analysis.
負(fù)責(zé)數(shù)據(jù)分析，數(shù)據(jù)審核和趨勢(shì)分析；
5.Provide technology support for production of MFG, assist in troubleshooting and solving problems.
對(duì)MFG的生產(chǎn)提供技術(shù)支持，并協(xié)助排查與解決問題；
6.According to the production process, review the relevant GMP production documents.
根據(jù)生產(chǎn)工藝，審閱相關(guān)GMP生產(chǎn)文件；
7.Summary change control of owner each project, Optimize and improve processes, improve efficiency.
總結(jié)每個(gè)項(xiàng)目的變更控制，并優(yōu)化和改善工藝，提高效率；
8.Communicate effectively with the company’s internal and external departments to successfully complete the project on time.
與公司內(nèi)外各部門進(jìn)行有效溝通，順利推動(dòng)項(xiàng)目按時(shí)完成；
9.Other work arranged by superior leaders.
上級(jí)領(lǐng)導(dǎo)安排的其他工作。