职位描述
原料药有机合成小分子化合物合成结构鉴定技术分离纯化技术
1、主导前列腺素类原料药的全合成路线设计、工艺开发与优化，解决关键合成难题（如手性控制、多步反应收率提升等）；
2、负责从实验室小试到中试放大及产业化的全链条技术转化，确保工艺符合成本控制与合规要求，如GMP；
3、协同分析团队建立原料药及中间体的质量控制标准（HPLC、GC、MS等分析方法开发与验证）；
4、协同注册部门完成CTD资料中化学部分的撰写与审核，支持国内外申报；
5、优化合成化学研发团队，制定技术培训计划；
6、跟踪全球前列腺素类药物专利与文献，规避侵权风险并布局差异化技术路线；
任职要求
1、教育背景：有机化学/药物化学博士学历（或硕士+10年经验），具有前列腺素或类似复杂分子全合成经验者优先；
2、精通多步有机合成（如碳链延长、HWE反应、Wittig反应等前列腺素合成关键步骤）；
3、熟悉分析技术（NMR、LC-MS、手性分离等）的数据解读与方法开发；
4、熟悉仿制药研发流程（QbD理念、杂质研究、稳定性考察）；
5、具备从0到1的项目管理能力，能平衡短期目标（如抢首仿）与长期技术储备；
6、英语读写熟练（需阅读专利文献及撰写国际注册文件）；
Job Description :
Lead the design, development, and optimization of synthetic routes for prostaglandin-based active pharmaceutical ingredients (APIs), resolving key challenges (e.g., chiral control, yield improvement in multi-step reactions).
Oversee end-to-end technology transfer from lab-scale to pilot-scale and commercialization, ensuring cost-effective and compliant processes (e.g., GMP).
Collaborate with analytical teams to establish quality control standards for APIs and intermediates (method development/validation via HPLC, GC, MS).
Co-author and review chemical sections of CTD dossiers , supporting global regulatory submissions.
Optimize synthetic chemistry teams, designing technical training programs.
Monitor global patents/literature on prostaglandin drugs to mitigate infringement risks and develop differentiated synthesis strategies.
Qualifications :
Education: PhD in Organic/Medicinal Chemistry (or MS + 10 years’ experience); candidates with prostaglandin or complex molecule total synthesis experience preferred.
Expertise: Mastery of multi-step organic synthesis (e.g., chain elongation, HWE reactions, Wittig reactions—key to prostaglandin synthesis).
Analytical Skills: Proficient in data interpretation and method development (NMR, LC-MS, chiral separation).
Regulatory Knowledge: Familiar with generic drug R&D (QbD, impurity profiling, stability studies).
Leadership: Proven project management skills to balance short-term goals (e.g., first-to-file) and long-term innovation.
Language: Fluent English for patent analysis and international regulatory documentation.
2、负责从实验室小试到中试放大及产业化的全链条技术转化，确保工艺符合成本控制与合规要求，如GMP；
3、协同分析团队建立原料药及中间体的质量控制标准（HPLC、GC、MS等分析方法开发与验证）；
4、协同注册部门完成CTD资料中化学部分的撰写与审核，支持国内外申报；
5、优化合成化学研发团队，制定技术培训计划；
6、跟踪全球前列腺素类药物专利与文献，规避侵权风险并布局差异化技术路线；
任职要求
1、教育背景：有机化学/药物化学博士学历（或硕士+10年经验），具有前列腺素或类似复杂分子全合成经验者优先；
2、精通多步有机合成（如碳链延长、HWE反应、Wittig反应等前列腺素合成关键步骤）；
3、熟悉分析技术（NMR、LC-MS、手性分离等）的数据解读与方法开发；
4、熟悉仿制药研发流程（QbD理念、杂质研究、稳定性考察）；
5、具备从0到1的项目管理能力，能平衡短期目标（如抢首仿）与长期技术储备；
6、英语读写熟练（需阅读专利文献及撰写国际注册文件）；
Job Description :
Lead the design, development, and optimization of synthetic routes for prostaglandin-based active pharmaceutical ingredients (APIs), resolving key challenges (e.g., chiral control, yield improvement in multi-step reactions).
Oversee end-to-end technology transfer from lab-scale to pilot-scale and commercialization, ensuring cost-effective and compliant processes (e.g., GMP).
Collaborate with analytical teams to establish quality control standards for APIs and intermediates (method development/validation via HPLC, GC, MS).
Co-author and review chemical sections of CTD dossiers , supporting global regulatory submissions.
Optimize synthetic chemistry teams, designing technical training programs.
Monitor global patents/literature on prostaglandin drugs to mitigate infringement risks and develop differentiated synthesis strategies.
Qualifications :
Education: PhD in Organic/Medicinal Chemistry (or MS + 10 years’ experience); candidates with prostaglandin or complex molecule total synthesis experience preferred.
Expertise: Mastery of multi-step organic synthesis (e.g., chain elongation, HWE reactions, Wittig reactions—key to prostaglandin synthesis).
Analytical Skills: Proficient in data interpretation and method development (NMR, LC-MS, chiral separation).
Regulatory Knowledge: Familiar with generic drug R&D (QbD, impurity profiling, stability studies).
Leadership: Proven project management skills to balance short-term goals (e.g., first-to-file) and long-term innovation.
Language: Fluent English for patent analysis and international regulatory documentation.
登录查看完整内容
