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Open nowPosted 281 days ago

双抗CMC总监

evopointbio/73901724 open roles

Where
Suzhou, Jiangsu, Chinese Mainland
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Your applicationOpen now双抗CMC总监evopointbio/739017 · Suzhou, Jiangsu, Chinese Mainland

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The clock on this job

Early applications get read.

11.5% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.0%1 day
  2. 4.3%3 days
  3. 11.5%7 days
  4. 18.1%14 days
  5. 35.6%30 days
  6. 44.6%60 days
This job: posted 281 days ago

The posting

岗位职责： 1.负责生物大分子项目整体工艺开发研究（涵盖CHO细胞培养，蛋白质修饰、多肽合成、纯化工艺、制剂工艺开发及分析方法开发等）以及CMC 相关技术问题解决。统筹CMC板块上下游整体工作，以支持研发、临床前和临床相关研究； 2.负责协调CMC 与其他团队的在项目推进中的密切配合； 3.负责与外部CDMO管理，并对外包项目的质量及进度进行监督和控制，确保项目如期按要求完成； 4.负责生物大分子项目IND申报中CMC有关的各项工作，对相关申报资料进行撰写与审核；

任职要求： (a)Academic/Major 学历/专业 生物制药相关专业博士学历 (b)Professional Skills 专业技能要求 具有单抗，双抗及多抗整体工艺开发与放大生产经验，包括CHO细胞培养，蛋白纯化等上下游工艺。 具有抗体改造和修饰经验 具有单双抗体的制剂研发和生产，了解biologics药品的分析方法开发及验证 对E. Coli培养，蛋白质工程有了解 (c)Working Experience 工作经验要求 拥有至少5年以上的抗体及生物大分子药物行业经验； 拥有生物大分子项目IND申报经验。

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