CMC Lead(J12466)
岗位信息
| 招聘单位 | 凯莱英 |
|---|---|
| 工作地点 | 上海市 |
| 官方更新时间 | 2025-09-27T20:32:07 |
职位描述
Lead CMC strategy & end-to-end process development；
Optimize formulation, analytical & manufacturing parameters；
Develop & validate CMC analytical methods for quality control；
Ensure compliance with regulatory (FDA/EMA/NMPA) & GMP standards；
Collaborate cross-functionally (R&D, QA, Production) for seamless tech transfer.
任职要求
Master's or above in Pharmacy, Pharmaceutical Sciences, Chemistry, or related fields; 5-15 years of CMC development experience in biologics/ADCs (including lead role in at least 2 commercialized projects), with expertise in formulation, analytical development, and GMP manufacturing, and familiarity with global regulatory requirements.
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