（Sr.）Scientist-Upstream Process Deve

岗位职责

- Execute tasks associated with media and buffer preparation operations (e.g. complex calculations, aseptic technique, chemical inventory, troubleshooting, cell culture media prep, dilutions, pH titration, conductivity, osmolality adjustment, and operations)
完成培养基和缓冲液制备操作相关的任务(例如:复杂计算、无菌技术、化学品库存、故障排除、细胞培养基准备、稀释、pH滴定、电导率、渗透压调整和操作)
- Develop feasible and scalable cell culture processes for Mab and complex molecules. Support the development of a streamlined and robust platform upstream process.
开发出可操作和放大的单抗及其他复杂分子的细胞培养工艺。支持创新和健壮的平台上游流程的开发。
- Develop a feasible and scalable upstream process for the promising large molecules. Evaluate CMC developability assessment for new modalities from upstream process development perspective. Support cell culture transferring projects to pilot scale manufacturing to support the IND and clinical development, collaborate closely with cross-functional teams to ensure programs timeline.
负责开发可行的及可放大的大分子上游工艺。从上游工艺开发角度评估新分子的CMC可行性, 支持细胞培养转移项目到试验规模生产以支持IND和临床发展,与多部门紧密合作以确保项目按计划开展
任职要求

- Bachelor’s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific discipline (Biology, Biochemistry, Chemistry, or related field) and 3-5 years of laboratory experience.
本科或大学学历，主修科学学科(生物、生物化学、化学或相关领域)，3-5年工作经验
- Experience in GLP/GMP environment preferred
有GLP/GMP工作经验者优先
- Independently interpret the more complex database and draw the effective conclusion for the experiments, Present it in the cross-function for integration and discussion.
能够独立完成数据的分析，甚至对部分比较复杂的数据也可以进行分析，并得出有效实验结论，能够在跨部门合作中对数据结果进行解读和讨论。
- Good understanding of CMC development process for biologics and working knowledge of regulatory requirement for product development
理解生物大分子药CMC开发流程，且对产品研发的注册要求有一定了解