岗位职责:
1.Optimize CHO cell antibody expression vectors and cell screening methods, analyze and resolve challenging issues encountered during cell line screening.
2.Develop and establish new technologies and platforms for cell line screening.
3.Propose solutions to relevant issues arising during project research.
4.Primarily involved in the preparation and submission of IND and BLA documents for ongoing projects in the United States and the European Union, and participate in communications with FDA and EMA.
1.进行CHO细胞抗体表达载体优化及细胞筛选方式优化,分析并解决细胞株筛选中的疑难问题。
2.进行细胞株筛选新技术、新平台的开发和搭建。
3.对项目研究过程中出现的相关问题,提出解决方案。
4.主要参与在研项目在美国和欧盟的IND及BLA资料撰写及申报,参与与FDA及EMA的沟通。
任职要求:
1.PhD or MSc in Molecular Biology, Cell Biology, Microbiology or closely related fields.
2.Possess more than 10 years of relevant work experience in molecular cloning, with profound theoretical and experimental knowledge in Molecular Biology. Familiar with the advantages and disadvantages of various components of expression vectors, and possess extensive experience in optimizing expression vectors. Priority will be given to candidates with experience in optimizing CHO cell expression vectors.
3.Have over 3 years of experience in cell line development, responsible for developing cell lines for more than 5 projects. Have a good understanding of the cell line screening process and technology, as well as extensive experience in optimizing the quality and quality control of antibody products.
4.Be well-versed in advanced technologies in antibody research and development, cell line screening, and other related fields within the industry, and possess the ability to establish platforms for these advanced technologies.
5.Have experience in submitting multiple domestic IND (Investigational New Drug) or BLA (Biologics License Application) applications,specifically possess experience of IND or BLA submission to FDA or EMA.
6.Have good English communication skills, capable of communicating with overseas clients or regulatory authorities in English. Possess excellent abilities to write technical reports and submission materials in English.
7.Demonstrate strong sense of responsibility and teamwork spirit.
1.分子生物学、细胞生物学、微生物学等相关专业,硕士及以上学历。
2.有10年以上分子克隆相关工作经验,具备精深的分子生物学理论知识和实验经验,熟悉表达载体各种元件的优缺点,具有丰富的表达载体优化经验,具有CHO细胞表达载体优化工作经验者优先。
3.具有3年以上细胞株开发经验,负责过5个项目的细胞株开发工作,熟知细胞株筛选的流程及技术,对抗体类产品质量优化、质量调节有丰富的经验。
4.熟知行业内先进的抗体研发、细胞株筛选等领域的先进技术,并能搭建相关先进技术平台的能力。
5.具有多个项目国内IND或BLA申报经验,特别是FDA或EMA IND或BLA申报经验。
6.有较好的英文沟通,可用英语与海外客户或监管机构进行沟通,具有良好的英文技术报告、申报资料撰写能力。
7.具有较强的责任心和团队合作精神。