Job Function
- Research & Development
Discipline
- Biochemistry
- Cell and Molecular Biology
- Pharmacy
Years of Experience
- 4-6 years
Job Details
Responsibilities
- 负责帶領團隊進行原料和mRNA/LNP产品的分析方法开发、验证和转移，技术写作
- 负责制定mRNA/LNP产品分析部门的研发策略和方向
- 负责原料药，中间体和候选产品的分析方法开发和筛选，解决开发过程中的技术难点, 建立平台
- 負責对中试放大和cGMP生产过程中出现的问题提供技术支持
- 对mRNA和LNP候选产品进行稳定性研究
- 对结果进行分析总结，并监督和指导实验进展
- 参与IND申报有关分析方法研究,注意项目风险，评估新技术
- 协同註冊团队，生成M2/M3数据包，支持IND申报
Requirements
- 分析化学、生物化学、药学、免疫学、分子生物学或其他相关专业教育学科, >5年工作经验的博士。负责过mRNA vaccine 或者 in vivo CAR项目
- 具备扎实生物大分子和/或核酸药物分析常用的物理化学方法和/或生物学方法研发经验
- 具备扎实的分析方法实验技能
- 具有质控QC 或GLP经验优先
- 具有mRNA疫苗分析方法经验优先
- 具有分析方法验证经验优先
- 熟悉监管机构要求或有申报经验的忧先
- 具有分析方法设计质量（QbD）经验优先
About the Company
Overview
Simcere Pharmaceutical Group Limited (2096.HK) is a pharmaceutical company driven by innovative R&D. We are committed to "For patients, for life." across the following core therapeutic areas: oncology, central nervous system, autoimmunity and anti-infection. Furthermore, we are also actively expanding our presence in disease areas with significant clinical needs in the future.
Our industry-leading capabilities and commitment to synergistic innovation have also enabled various strategic collaborations and we are seen as the partner of choice by innovative biopharmaceutical companies, medical institutes, and research teams in China and globally.