职位描述
主要职责:
1. 负责包括单抗、双抗、酶等重组蛋白的细胞株构建与筛选,如载体设计、细胞池筛选、高表达单克隆筛选、细胞株稳定性研究、原始细胞库建库等,满足项目对产量和质量的要求;
2. 负责技术平台优化,如宿主细胞驯化和基因工程改造、载体优化、细胞筛选方法优化等,建立高效高产的稳转细胞构建平台;
3. 负责撰写细胞株构建相关技术报告和申报资料,确保实验过程和数据记录及时、清晰、准确、合规;
4. 负责解决项目开发过程中遇到问题,能够独立分析原因、进行trouble shooting,及时提出可行的解决方案;
5. 与项目管理、工艺开发、质量分析等相关部门紧密合作,确保项目按时且高质量推进。
Key Responsibilities:
1. Responsible for cell line development of recombinant proteins including monoclonal antibodies, bispecific antibodies, enzymes, and others. Key activities include vector design, cell pool selection, high-producing mono-clone screening, stability studies, and establishment of primary cell banks (PCBs), to ensure that project requirements for product yield and quality are met.
2. Responsible for the optimization of technical platforms, including host cell adaptation and genetic engineering, vector optimization, and cell screening methods optimization, in order to establish an efficient, high-yield stable cell line development platform.
3. Responsible for preparing technical reports and regulatory submission documents related to cell line development, ensuring that experimental procedures and data records are timely, clear, accurate, and compliant.
4. Responsible for resolving issues encountered during project development; able to independently analyze root causes, conduct troubleshooting, and propose feasible solutions in a timely manner.
5. Work closely with relevant departments, including project management, process development, and quality analytics, to ensure projects are delivered on time and to a high standard of quality.