岗位职责:
1.负责项目小试规模(摇瓶、3L及15L反应器）上游细胞培养工作，进行上游细胞培养的工艺开发、优化、工艺表征及工艺验证相关工作。
Be responsible for the upstream cell culture of process development department (shake flask, 3L and 15L BR). Conduct the process development, optimization, process characterization and process validation related work of upstream cell culture.
2.执行项目计划，书写实验记录，按计划完成实验数据的汇总整理，撰写阶段性总结报告。
Execute the project plan, write experimental records, complete the summary and collation of experimental data as planned, and write phased summary reports.
3.参与项目细胞培养实验方案设计，分析培养过程中遇到的问题并提出解决思路。
Participate in the design of cell culture experiment schemes for projects, analyze the problems encountered in the culture process and propose solutions.
4.参与实验室5S管理，负责实验区域设备的清洁，定期维护保养。
Participate in laboratory 5S management, be responsible for cleaning the equipment in the experimental area and conduct regular maintenance.
5.完成工艺开发后与中式生产部门协作完成小试到中试的工艺转移，协助注册部门撰写申报资料。
After completing process development, collaborate with the Chinese production department to complete the process transfer from pilot scale to pilot production scale, and assist the registration department in writing application materials.
6.配合生产部完成细胞培养工艺设计、工艺设备选型和验收、安装调试及验证工作。
Cooperate with the production department to complete the cell culture process design, selection and acceptance of process equipment, installation, commissioning and verification.
7.完成公司和上级领导下达的其它日常性和临时性工作。
Completion of other daily and temporary work assigned by the company and higher management.
8.认真贯彻执行国家和公司制定的方针政策以及各项规章制度。
Conscientiously implement the guidelines and policies formulated by the state and the company, as well as various rules and regulations.
9.负责贯彻执行国家药品生产管理相关的法律、法规。
Responsible for the implementation of national laws and regulations related to drug production management.
任职要求:
1.3年以上抗体类药物上游细胞培养工艺开发经验；有CDMO细胞培养工艺开发经验优先。
More than 3 years of experience in upstream cell culture process development for antibody drugs; experience in CDMO cell culture process development is preferred.
2.具有文献检索能力，熟悉抗体药上游工艺开发流程，熟悉法规指导原则及操作规范。
Capable of literature search, familiar with the upstream process development of antibody drugs, familiar with regulatory guidance principles and operational norms.
3.具有一定的DoE实验设计与分析能力，熟悉JMP/Minitab等分析软件。
Have certain ability in DoE experimental design and analysis, familiar with analysis software such as JMP/Minitab.
4.熟悉生物制药工艺流程和相关技术。
Familiar with biopharmaceutical process and related technology.
5.做事细心，为人踏实，责任心强，有强烈的学习意愿。
Attentive in work, down-to-earth in personality, strong sense of responsibility, and a strong willingness to learn.