职位描述
职责描述:1.Responsible for preformulation support to our promising pipeline of biotherapeutics, planning and executing developability assessments负责我们有前景的生物药的处方前研究，计划并进行可开发性的评估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.在实验室领导进行新的蛋白药物的冻干制剂处方开发，开发冻干循坏工艺等提高药物的稳定性。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.蛋白的水针制剂和冻干粉的稳定性测试以及降解途径的分析，包括加速试验、长期实验以及振荡、冻融挑战实验4.Good interpretation of biophysical instrumentation (DSC, FTIR, CD, DLS etc.) data.对于生物物理相关设备（差示扫描量热仪，傅里叶变换红外仪，圆二色光谱仪，动态光散射仪等）有较好地理解。5.Support of Drug Product manufacturing may be performed, which include process robustness and tech transfer activities.支持制剂成品的生产，包括生产过程的稳定性和技术转移。6.Review analytical data for completeness and correctness.审核分析数据的完整性和正确性。7.Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.撰写用于申报材料的正式的报告文件并支持和书写合适的反馈来回答监管部门的问题。任职要求:1.PhD with 1+ years, or MS with 3+ years of industrial experience in pharmacy, pharmaceutics, biochemistry, biotechnology, or other related disciplines.制剂学、制药学、生物化学、生物技术或其他相关背景的1年以上经验博士或者3年以上经验的硕士。2.Hands-on experience and deep understanding of lyophilization process development and lyophilized products有冻干制剂的实际操作开发经验并对冻干过程和产品有深厚的理解。3.Good interpretation of protein characterization techniques, including data analysis of HPLC, CE, DLS, DSC etc.具有丰富的蛋白质表征经验，包括高效液相色谱，毛细管电泳，动态光散射，差示扫描量热法的数据分析。4.Strong problem-solving and troubleshooting skills.有较强的解决问题或排错能力。5.Familiar with GMP is a plus熟悉GMP生产更佳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.有较强的团队合作精神和优秀的交流技巧，有活力，高度自我激励并能够在成长性企业氛围中有效的工作。
