Job opening - 多肽CMC工艺经理 in 上海
【岗位职责】 1.多肽原料药全流程工艺开发与策略制定 - 主导多肽类创新药原料药从工艺路线筛选、小试优化、中试放大到GMP商业化生产的全生命周期工艺开发，针对固相合成、液相合成或固液结合合成路线进行系统性优化，攻克多肽合成过程中缩合不完全、消旋、杂质难去除等行业共性难题。 - 结合候选多肽分子的结构特性及临床推进阶段，制定分阶段工艺开发策略，明确关键工艺参数与关键质量属性，建立稳健可控的生产工艺，支撑后续原料药成本控制，制剂开发与注册申报需求。 - 针对多肽分子的特殊属性，牵头开展聚合、降解、异构体等关键杂质的定向研究，建立杂质溯源与控制策略，保障原料药质量符合国内外注册要求。 2.工艺放大、技术转移与合规管理 - 主导多肽工艺从实验室小试工艺确认到...
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