主要职责：
1.参与药品从研发到生产的全流程技术转移，审核技术转移报告、起草验证方案及报告
2.参与药品的工艺攻关，负责药品关键工艺数据的收集、统计分析，为工艺和成本优化提供解决方案
3.监督GMP合规落实，负责工艺文件更新、验证管理、偏差管理及应对国内外认证核查
4.跟踪药品生产领域的技术发展(如AI)，负责制药新技术的探索、评估、试用及推广
5.跟进 FDA/EMA/WHO/ICH/NMPA 的法规动态，负责法规新政策的解读、翻译、培训及落地 6.深度学习成为药品生产一、两个专项领域的SME，引领工厂技术水平提升
7.深度参与卓越运营工作，提升工厂运营效率
任职资格：
教育背景 ： 有机化学、药学、药剂学相关专业，硕士及以上学历、博士优先
相关经验 ：良好的有机合成或药剂学实验能力
语言要求 ：英语听说读写流利
其他技能 ：熟练操作数据统计软件
能力要求：
1.对药品生产领域有浓厚的兴趣，并愿意在该领域长期发展
2.逻辑清晰，有科学严谨的工作思路
3.主动性强，学习能力强
工作地点：连云港、成都、山东、福建、上海、苏州、广东
Responsibilities
Qualifications
Education:
Master’s degree or above in Organic Chemistry, Pharmacy, Pharmaceutics or related fields; PhD preferred.
Experience:
Solid experimental skills in organic synthesis or pharmaceutics.
Language:
Fluent in English (listening, speaking, reading, writing).
Other Skills:
Proficient in using data analysis/statistical software.
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