崗位職責(zé):

1.Responsible for preformulation support to our promising pipeline of biotherapeutics, planning and executing developability assessments
負(fù)責(zé)我們有前景的生物藥的處方前研究，計(jì)劃并進(jìn)行可開發(fā)性的評估
2.Hands-on, laboratory-based role that supports the development of lyophilization for therapeutic protein formulations. Develop lyophilization cycles & processes to increase stability of the drug products.
在實(shí)驗(yàn)室領(lǐng)導(dǎo)進(jìn)行新的蛋白藥物的凍干制劑處方開發(fā)，開發(fā)凍干循壞工藝等提高藥物的穩(wěn)定性。
3.Stability testing and characterization of routes of degradation of proteins in liquid and lyophilized formulations under accelerated temperature, refrigerated storage conditions and under agitation and freeze-thaw stresses.
蛋白的水針制劑和凍干粉的穩(wěn)定性測試以及降解途徑的分析，包括加速試驗(yàn)、長期實(shí)驗(yàn)以及振蕩、凍融挑戰(zhàn)實(shí)驗(yàn)
4.Good interpretation of biophysical instrumentation (DSC, FTIR, CD, DLS etc.) data.
對于生物物理相關(guān)設(shè)備（差示掃描量熱儀，傅里葉變換紅外儀，圓二色光譜儀，動(dòng)態(tài)光散射儀等）有較好地理解。
5.Support of Drug Product manufacturing may be performed, which include process robustness and tech transfer activities.
支持制劑成品的生產(chǎn)，包括生產(chǎn)過程的穩(wěn)定性和技術(shù)轉(zhuǎn)移。
6.Review analytical data for completeness and correctness.
審核分析數(shù)據(jù)的完整性和正確性。
7.Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
撰寫用于申報(bào)材料的正式的報(bào)告文件并支持和書寫合適的反饋來回答監(jiān)管部門的問題。

1.PhD with 1+ years, or MS with 3+ years of industrial experience in pharmacy, pharmaceutics, biochemistry, biotechnology, or other related disciplines.
制劑學(xué)、制藥學(xué)、生物化學(xué)、生物技術(shù)或其他相關(guān)背景的1年以上經(jīng)驗(yàn)博士或者3年以上經(jīng)驗(yàn)的碩士。
2.Hands-on experience and deep understanding of lyophilization process development and lyophilized products
有凍干制劑的實(shí)際操作開發(fā)經(jīng)驗(yàn)并對凍干過程和產(chǎn)品有深厚的理解。
3.Good interpretation of protein characterization techniques, including data analysis of HPLC, CE, DLS, DSC etc.
具有豐富的蛋白質(zhì)表征經(jīng)驗(yàn)，包括高效液相色譜，毛細(xì)管電泳，動(dòng)態(tài)光散射，差示掃描量熱法的數(shù)據(jù)分析。
4.Strong problem-solving and troubleshooting skills.
有較強(qiáng)的解決問題或排錯(cuò)能力。
5.Familiar with GMP is a plus
熟悉GMP生產(chǎn)更佳
6.Strong collaborative teamwork and excellent communication skills, is energetic, highly self-motivated and able to work efficiently and productively in a growing company environment.
有較強(qiáng)的團(tuán)隊(duì)合作精神和優(yōu)秀的交流技巧，有活力，高度自我激勵(lì)并能夠在成長性企業(yè)氛圍中有效的工作。