Job Description

Job Description

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:

1. Strong interest in pharmaceutical production with willingness for long-term career development in this field.
2. Clear logical thinking and a rigorous scientific mindset.
3. High initiative, strong learning ability.

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