制剂开发科学家 - Minhang District, Shanghai

仅限注册会员 Minhang District, Shanghai, 中国

1个月前

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核心职责 · 1. · 制剂开发与优化 · Ø 主导大分子药物(单抗/双抗/XDC/融合蛋白类等)的处方前研究、处方筛选、工艺开发(冻干/液体制剂)、稳定性研究等项目申报相关工作。 · Ø 设计实验方案,解决处方工艺放大、稳定性异常、可见异物、蛋白聚集、碎片等复杂技术问题。 · Ø 带领团队完成从IND到BLA的制剂开发和优化工作。 · 2. · 国际合作对接 · Ø 作为制剂技术接口人,负责与欧美合作伙伴的全周期协作: · Ø 参加跨国技术会议,清晰阐述实验设计、数据结论与问题解决方案; · Ø 撰写英文技术报告、CTD申报资料章节,确保符合FDA/E ...
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