莆田招聘

岗位职责:

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。

任职资格:

1. PhD with 2 years, or MS with 4+ 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2年经验博士或者4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。

    先声药业是一家快速转型为创新和研发驱动的制药公司，获批建设 “转化医学与创新药物国家重点实验室”，致力于“让患者早日用上更有效药物”。先声药业专注于肿瘤（含细胞治疗）、中枢神经和自身免疫三大治疗领域，拥有多元化且领先的创新产品组合。秉持自主研发与合作研发双轮驱动的策略，先声药业与多家全球医药企业及生物技术公司成为战略合作伙伴，促进全球生命科学成果在中国的价值实现。