JD:
1、负责生物药新产品各阶段结构研究、活性功能评价、理化性质研究、杂质研究，稳定性研究等药学研究；
2、负责生物药项目开展过程中相关质量评价方法的开发、优化、验证及转移；
3、负责生物药产品上市前阶段质量标准的建立；
4、负责新药分子IND申报、NDA申报、上市后产品补充申请及相关资料撰写，满足国内外注册申报要求；
5、负责国内外新技术平台引进，优化理化、色谱、质量表征各平台建设提升体系内部创新研发能力，搭建有技术壁垒的研发技术平台，快速推进项目的实施；
6、对公司引进项目，负责组织完成质量研究领域内相关策略分析、尽调、评估等工作；
任职资格：
1、博士，生物技术、生物工程、生物化工、制药工程等相关专业
2、熟悉多种理化分析方法和技术；
3、熟悉蛋白质产品（如抗体， 融合蛋白，ADC等）的主要表征分析方法及手段；
4、对FDA及ICH指南中对生物制药的CMC研发要求有较好的理解；
5、 语言要求：熟练的英文阅读及文献检索能力；
6、优先条件：海外经历、科研专利、创新技术等；

Analytical Development Scientist
Job Description:
1. Responsible for conducting pharmacological researches of new biopharmaceutical drugs at different stages, including structural studies, functional activity evaluation, physicochemical properties research, impurity studies, and stability studies.
2. Responsible for analytical methods development, optimization, validation, and transfer during the biopharmaceutical drug progress.
3. Responsible for establishment of the quality specifications of biopharmaceutical products.
4. Contribute to dossier preparation of Investigational New Drug (IND), New Drug Applications (NDA), post-approval changes submission to meet domestic and international markets.
5. Responsible for introduction of new technology platforms, improvement of the current physico-chemical platform, chromatographic platform, and quality characterization platform, facilitating process development projects.
6. Responsible for due diligence and evaluation of the newly-introduced projects in analytical development areas.
Qualifications:
1. Ph.D. in Biochemistry, Biotechnology, Bioengineering, Biochemical Engineering, Pharmaceutical Engineering or related biological fields.
2. In-depth knowledge with a variety of physico-chemical analytical techniques .
3. Familiarity with protein drugs (such as antibodies, fusion proteins, ADCs, etc.) characterization and analytical methods
4. Knowledge of regulatory requirements (FDA, EMA) for the CMCdevelopment of biopharmaceuticals.
5. Language requirement: Proficient in English.

6. Preferred qualifications: US/EU experience preferred, and publications/patents, familiar with advancement of related areas highly recommended.
工作地点：长春

其他信息

行业要求：全部行业
所属部门：分析开发中心