仪器分析

作者:天津大学分析化学教研组

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外资大型制药公司技术、研发、质量总监,验证管理资深专家,多家制药公司顾问,药学硕士。国家工艺核对未雨绸缪之际,成功解决了多家在产产品处方、工艺问题。处方工艺的二次开发,免费咨询,全程保密。邮箱:1193686015@qq.com。

     

细胞株构建总监/Director, Cell Line Development

细胞株构建总监
岗位职责:
1.带领团队进行抗体和蛋白质类药物高产稳定CHO工程细胞株的构建,获得适于工业生产的工程细胞株。
2.负责制定工程细胞株构建实验方案,指导并解决实验过程中遇到的问题;
3.根据项目特点,制定行之有效的策略,提升表达较低项目工程细胞株产量。
4.负责稳定表达单克隆细胞株的构建、筛选与评价,根据每个克隆特点进行培养基的筛选与优化;
5优化工程细胞株平台,包括宿主细胞的工程化改造,表达载体的优化,构建方式及筛选方式的优化;
6.指导实验数据的整理,报批文件的撰写;
7.负责工程细胞株技术平台的管理、人员培训、实验室日常运营管理。
8.负责与工艺、质量、项目管理等部门开展密切合作;
任职要求:
1.博士,分子生物学、细胞生物学、生物化学等相关专业;
2.在国内外生物药企或研发单位进行过至少5年以上CHO工程细胞株开发工作;有海外大型药企背景者优先;
3.熟悉细胞株构建、筛选及细胞株稳定性研究等关键工作;
4.熟悉抗体关键质量属性,熟悉细胞培养工艺放大,完成过中试以上级别的细胞培养。
5. 熟悉各种工程细胞株构建表达系统及筛选手段,拥有丰富的基因工程、分子克隆、蛋白表达经验; 
6.熟悉生物制药行业相关法规,熟悉细胞株构建领域的新技术及专利状态,并制定相应的策略。
7.有双特异抗体及其他复杂蛋白的细胞株构建经历优先。

Director, Cell Line Development
Job Description:
1. Lead the team to construct the high yield CHO cell line of therapeutic antibodies and proteins for industrial production.
2. Responsible for cell line development experiment design and troubleshooting. 
3. Make effective strategies to improve the expression level of cell lines according to the characteristics of each project.
4. Responsible for the stable cell line development, screening and culture medium optimization.
5 Optimize the cell line development platform, including the host cell gene modification, expression vector optimization, screening method optimization.
6. To guide the experimental data management, and material writing for application;
7. Responsible for the management of cell line development platform, personnel training, daily laboratory management.
8. Cooperate effectively with process, quality, project management and other departments

Requirements:
1. Ph. D. In molecular biology, cell biology, biochemistry and other related majors;
2. 5 years or above experience in CHO cell line development; overseas’ working experience is preferred.
3.Experienced in cell line development, screening and cell line stability study;
4. Be familiar with antibody key quality attribute, experienced in amplification, pilot scale production or above. 
5. Familiar with a variety of cell line development systems and screening methods, skilled in gene engineering, molecular cloning and protein expression.
6. Familiar with the pharmaceutical related laws and regulations, familiar with new technology of cell line development field and their patent status.
7.Experience in cell line development of bi-specific antibodies and complex proteins is preffered.

有意或有人推荐者,可电话联系:15058072748,微信:lh15058072748

邮箱:yinyinbeibei@163.com


本职位待遇可根据候选人实力协商,待遇优于市场价,公司为国内集团公司,实力雄厚,在美国新泽西建有生物药研发中心。目前中心有三十余人。

执业药师考试用书2017 2017国家执业药师考试同步题库 药学专业知识(二) 执业药师 2017年执业药师考试用书

作者:国家执业药师资格考试研究组

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洋葱头历险记–洋葱头儿童文学精选

作者:贾尼·罗大里

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始发于微信公众号: 制药工程论坛

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