理化检验员(019540)

岗位职责:
1. 负责日常的生物制品原液/成品的放行检测、中间样品检测、稳定性研究及检验仪器的日常维护、保养、验证。
Responsible for release testing of DS/DP, in-process testing, stability studies, and daily maintenance and verification of analytical instrument.
2 .参与制订CE、iCIEF、蛋白含量（UV280）等分析方法的验证方案、开展验证实验、撰写验证报告、SOPs、申报资料的准备及相关资料归档工作。
Write and revise transferring and validation protocol, reports and SOPs for CE, iCIEF, protein content (UV280) and other analysis methods. Perform validation experiments, prepare application documents and archive related materials.
3. 识别理化检测相关的异常、OOS/OOT/OOE、偏差等质量问题，并调查分析、改进。
Identify quality issues such as abnormalities, OOS/OOT/OOE, and deviations related to physical and chemical testing, and investigate, analyze, and improve them.

任职要求:
1. 至少本科2-4年、硕士1-2年生物大分子药品生产企业QC经验。
With min. 2-4 years of bachelor's degree and 1-2 years of master's degree in QC experience in biologics manufacturers.
2. 分析化学、药物分析、生物化学、药学等相关专业。
Analytical chemistry, Drug analysis, Biochemistry, Pharmacy and other related majors.
3. 对CE（Maurice&PA800 Plus）等仪器有所了解，有使用还原及非还原CE、蛋白含量（UV280）等方法分析蛋白类药物的经验者优先。
With hands-on experiences with reduced and non-reduced CE-SDS and protein content (UV280) and other analytical methods is preferred.
4. 了解GMP规范和要求，对ChP、EP、USP、ICH、PDA等相关法律、法规、技术指导原则有一定了解。
Understand GMP requirements, and have a certain understanding of relevant regulations, and technical guidelines such as ChP, EP, USP, ICH, and PDA.
5. 英文读写能力良好，可以阅读英文文献，翻译、撰写英文文件。
Good English reading and writing skills, able to read, write and translate documents.
6. 诚实正直、好学敬业、注重细节、乐于沟通，具有良好的团队协作能力。
Honest and upright, eager to learn and dedicated, pay attention to details, willing to communicate, and have good teamwork skills.