制剂研发主管

1、主导小容量注射剂、滴眼剂的处方设计、工艺开发及优化，解决关键技术难点（如无菌工艺、渗透压调节、眼用制剂刺激性控制等）；
2、负责从实验室小试到中试放大及产业化的全流程技术转移，确保工艺符合GMP要求；
3、独立撰写CTD申报资料中的制剂部分，包括处方工艺开发报告、质量研究、稳定性考察等；
4、配合注册部门完成发补问题的技术回复，主导申报过程中的技术沟通；
5、具备动手能力，可亲自参与关键实验；
6、跨部门协调分析、生产及质量团队，建立制剂质量控制策略（如可见异物、无菌保证）；
任职要求
1、教育背景：药学、药剂学或相关专业本科及以上学历（硕士优先），5年以上注射剂/滴眼液研发经验，有前列腺素类制剂项目经验者优先；
2、精通无菌注射剂和滴眼液的开发流程；
3、熟悉国内外制剂申报法规；
4、能独立设计DoE实验并分析数据（如稳定性试验箱、溶出度仪等设备操作）；
5、兼具“顶层设计”与“动手能力”，既能规划研发策略又可下沉解决实验问题；
6、英语读写熟练（需解读专利、撰写国际注册文件）；
Job Description :
Lead formulation design, process development, and optimization for small-volume injectables and ophthalmic solutions, addressing key technical challenges (e.g., aseptic processing, osmolality adjustment, ocular irritation control).
Oversee full-cycle technology transfer from lab-scale to pilot-scale and commercialization, ensuring compliance with GMP standards.
Independently prepare the drug product sections of CTD dossiers, including formulation development reports, quality studies, and stability testing documentation.
Collaborate with regulatory teams to address technical queries during submissions and lead scientific communications with authorities.
Hands-on involvement in critical experiments to resolve development bottlenecks.
Coordinate cross-functionally with analytical, manufacturing, and quality teams to establish robust quality control strategies (e.g., visible particulates, sterility assurance).
Qualifications :
Education: Bachelor’s or Master (preferred) in Pharmacy, Pharmaceutics, or related fields; 5+ years of R&D experience in injectables/ophthalmic solutions. Candidates with prostaglandin-based formulation expertise are prioritized.
Expertise: Proficient in sterile injectable and ophthalmic product development workflows.
Regulatory Knowledge: Familiar with global drug product registration requirements.
Technical Skills: Capable of independently designing DoE experiments and analyzing data (e.g., stability chambers, dissolution testers).
Dual Competency: Strategic mindset for R&D planning paired with hands-on problem-solving in lab settings.
Language: Fluent English for patent review and international regulatory documentation drafting.