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CMC Lead(J12466)

Asymchem · 上海市

External listingFull-time10 months ago

About The Role

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​​.

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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