岗位职责:
1.落实上游工艺开发、技术转移，开展上游工艺表征、工艺验证，进行生产指导。
Implement cell line development, upstream process development, and technology transfer. Conduct upstream process characterization and process validation, and provide production guidance.
2.撰写、审核项目研发、生产等申报相关工作。
Compose and review the declaration - related work for project R & D, production, etc.
3.负责上游工艺开发团队管理、人员招聘、人员培训等。
Be responsible for the management of the upstream process development team, staff recruitment, personnel training, etc.
4.细胞库、上游工艺实验室统筹管理；
Overall management of the cell bank and the upstream process laboratory.
5.负责上游工艺开发年度预算申报、成本核算、仪器设备采购申请等事宜，确保上游工艺开发项目随时运行。
Be responsible for matters such as the annual budget declaration for upstream process development, cost accounting, and application for the procurement of instruments and equipment, to ensure the smooth operation of upstream process development projects at all times.
6.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.
7.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.
8.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:
1.5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。生物制药、生物技术、生物工程及相关专业，本科以上学历
More than 5 years of experience in upstream cell culture process development for antibody drugs; experience in CDMO cell culture process development is preferred.Bachelor
s degree or above in Biopharmaceuticals, Biotechnology, Bioengineering and related fields.
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.