Job Responsibilities 工作職責(zé)：
1. Participate in protein physicochemical analysis, including HPLC and CE related analytical methods，protein content by UV, etc.
參與蛋白理化分析，包括HPLC有關(guān)分析方法，毛細(xì)管電泳有關(guān)分析方法，UV蛋白含量檢測等；
2. Participate in analytical method development, qualification and method transfer.
參與理化檢測的分析方法開發(fā)，確認(rèn)和方法轉(zhuǎn)移；
3. 3Per SOPs, perform routine analysis of process development samples from MSAT and other non-GMP samples, including in-process samples.
根據(jù)SOP執(zhí)行MSAT部門工藝開發(fā)樣品和其它non-GMP 樣品的常規(guī)分析，包括中控樣品等；
4. Provide analytical technical support to upstream and downstream process development groups during process development and troubleshooting. Support formulation development, tech transfer and scale-up activities.
對上下游的工藝開發(fā)提供分析支持并協(xié)助排查與解決問題，對制劑開發(fā)、技術(shù)轉(zhuǎn)移、放大工藝提供分析技術(shù)支持；
5. Perform technical writing assignments such as SOPs, protocols, reports, risk assessments, laboratory investigations, and etc.
負(fù)責(zé)起草技術(shù)文件包括操作規(guī)程，草案，報(bào)告，風(fēng)險(xiǎn)評估，實(shí)驗(yàn)室調(diào)查報(bào)告等；
6. Conduct the stability study, including long-term, accelerated and forced degradation stability tests.
執(zhí)行穩(wěn)定性實(shí)驗(yàn), 包括長期穩(wěn)定性、加速穩(wěn)定性、強(qiáng)制降解研究；
7. Write and review IND, BLA and other regulatory documents.
撰寫和審核IND,BLA和其他法規(guī)文件；
8. Perform analytical data analysis, data review and trending analysis.
負(fù)責(zé)數(shù)據(jù)分析，數(shù)據(jù)審核和趨勢分析；
9. Other work arranged by superior leaders.
上級領(lǐng)導(dǎo)安排的其他工作。
Qualification 任職資格：
1. Be familiar with equipment for protein/biologics analysis, such as UV spectrometer, SoloVPE, HPLC, CE, MALS, SPR, CD, DSC, HIAC, Karl Fischer and etc.
熟悉蛋白生物藥分析儀器，包括UV分光儀、SoloVPE、HPLC、毛細(xì)管電泳、多角度靜態(tài)光散射、表面等離子共振、圓二色光譜、示差熱卡計(jì)、不溶性微粒檢測、卡式水分儀等；
2. Be familiar with analytical method development, qualification, validation and method transfer of physicochemical tests.
熟悉理化分析的方法開發(fā)，確認(rèn)，驗(yàn)證和轉(zhuǎn)移過程；
3. Understand ICH，ChP regulations and guidelines.
了解ICH, ChP法規(guī)和指導(dǎo)原則；
4. Excellent oral and written communication skills in English.
良好的英文口語和書面溝通能力；
5. Master degree or above, in chemistry, biology, life sciences or related disciplines, candidates with a bachelor's degree with relevant experience are also eligible.
碩士及以上學(xué)歷，化學(xué)、生物學(xué)、生命科學(xué)或相關(guān)專業(yè)，本科學(xué)歷有相關(guān)經(jīng)驗(yàn)的候選人也可；
6. Analytical experience in biopharmaceutical industry is preferred.
具有生物制藥行業(yè)的分析相關(guān)工作經(jīng)驗(yàn)者優(yōu)先考慮。