職位描述
職責(zé)描述: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(kāi)發(fā)性的評(píng)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(kāi)發(fā)，開(kāi)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(cè)試以及降解途徑的分析，包括加速試驗(yàn)、長(zhǎng)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(duì)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(guò)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(xiě)用于申報(bào)材料的正式的報(bào)告文件并支持和書(shū)寫(xiě)合適的反饋來(lái)回答監(jiān)管部門的問(wèn)題。任職要求: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(kāi)發(fā)經(jīng)驗(yàn)并對(duì)凍干過(guò)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(wèn)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(zhǎng)性企業(yè)氛圍中有效的工作。
