Hengrui Pharma
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 Participate in the full process of technology transfer from R&D to production, review technology transfer reports, and draft validation protocols and reports. Engage in process troubleshooting, collect and statistically analyze critical process data, and provide solutions for process and cost optimization. Monitor GMP compliance implementation, responsible for updating process documents, validation management, deviation management, and responding to domestic and international inspections. Track technological advancements in pharmaceutical manufacturing (e.g., AI), responsible for exploring, evaluating, piloting, and promoting new pharmaceutical technologies. Follow regulatory updates from FDA/EMA/WHO/ICH/NMPA, responsible for interpreting, translating, training, and implementing new regulatory policies. Develop expertise in one or two specialized areas of pharmaceutical production to become an SME, thereby enhancing the factory’s technical capabilities. Actively participate in operational excellence projects to improve factory efficiency.
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. Additional Competencies: Strong interest in pharmaceutical production with willingness for long-term career development in this field. Clear logical thinking and a rigorous scientific mindset. High initiative, strong learning ability.
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 Participate in the full process of technology transfer from R&D to production, review technology transfer reports, and draft validation protocols and reports. Engage in process troubleshooting, collect and statistically analyze critical process data, and provide solutions for process and cost optimization. Monitor GMP compliance implementation, responsible for updating process documents, validation management, deviation management, and responding to domestic and international inspections. Track technological advancements in pharmaceutical manufacturing (e.g., AI), responsible for exploring, evaluating, piloting, and promoting new pharmaceutical technologies. Follow regulatory updates from FDA/EMA/WHO/ICH/NMPA, responsible for interpreting, translating, training, and implementing new regulatory policies. Develop expertise in one or two specialized areas of pharmaceutical production to become an SME, thereby enhancing the factory’s technical capabilities. Actively participate in operational excellence projects to improve factory efficiency.
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. Additional Competencies: Strong interest in pharmaceutical production with willingness for long-term career development in this field. Clear logical thinking and a rigorous scientific mindset. High initiative, strong learning ability.