岗位职责:
Key responsibilities
主要职责
1.Responsible for physicochemical analysis and characterization of therapeutic antibodies, including methods such as: SEC, IEC, LC/MS, CE, SPR, various biophysical and spectrophotometry based methods.
负责治疗性抗体的理化分析和表征，方法包括分子排阻色谱，离子交换色谱，液质联用，毛细管电泳，表面等离子共振以及各种生物物理和光谱相关的方法。
2.Develop, optimize and validate new analytical methods.
开发、优化以及验证新的分析方法。
3.Support drug substance process development including characterization of starting materials, intermediates and final drug substance.
支持原液工艺开发，包括起始物，中间产物和最终原液的分析表征。
4.Support drug product formulation and process development including characterization of the process and finished product.
支持成品的制剂开发，包括中间和最终产物的表征分析。
5.Drug substance and drug product impurity characterization and identification. Analyze the stability issues of drug substance and drug product.
药物原液和制剂的杂质表征和鉴定。分析药物原液和制剂的稳定性问题。
6.Review analytical data for completeness and correctness.
审核分析数据的完整性和正确性。
7.Report and discuss analytical results and conclusions both orally and in writing.
口头或书面报告和讨论分析的结果和结论。
8.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:
Preferred qualification
首选的资格
1.MS in biochemistry, protein chemistry, structural biology or other protein science-related disciplines with three or more years of relevant experiences. Oversea study or working experience is a plus.
拥有三年以上经验的生物化学、蛋白质化学、结构生物学或者其他蛋白质科学相关背景的硕士，海外学习或工作经验更佳。
2.Comprehensive knowledge of protein science with extensive experience in protein characterization. Experience working with therapeutic antibodies is a plus.
在蛋白质科学方面有完整系统的知识并在蛋白质表征方面有丰富的经验。有治疗性抗体研究经验的更佳。
3.Extensive hands-on laboratory experience with and an in-depth knowledge of protein characterization techniques such as HPLC, LC/MS, CE, CD, DLS.
在蛋白质表征技术例如高效液相色谱、液质联用、毛细管电泳、圆二色谱、动态光散射等方面有较多的实际操作经验并有深厚的理论基础。
4.Strong problem-solving and troubleshooting skills.
有较强的解决问题或排错能力。
5.Strong capabilities in experimental design and execution.
在实验设计和执行方面有极强的能力。
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。
7.Solid track record of publication, presentation, and achievement.
有较好的发表文章、报告和荣誉。