求置顶/智联招聘携6家公司9月份在德国办招聘会，详情...

952626942

盛迪医药有限公司  分析部研发总监  R&D system- Analytical R&D Director：

1、药学、药物分析等相关专业，博士及以上学历；
2 、具有扎实的药物分析理论知识和操作技能，熟悉常用分析设备及制剂设备；
3、熟悉常用医药网站和数据库，熟悉药品开发的相关政策法规、流程、药品研发的相关技术指导原则及申报技术要求；
4、能够独立完成化学药品质量分析方法摸索、分析方法验证和转移、质量标准起草、稳定性研究工作；
5、能够按照CTD格式，撰写化学药品注册申报资料及相关材料；
6、工作积极主动、责任心强，具有较强的沟通和协调能力；
7、负责项目整体分析技术研究工作，并负责进度管理和推进；
8、制定项目具体实验方案，配合处方筛选检验，完成分析方法摸索、分析方法验证和转移、质量标准起草、稳定性研究工作，负责分析仪器和设备的管理；
9、分析项目技术难点，配合制剂工作，解决分析方法验证和转移、质量标准起草、稳定性考察过程中的难点和相关技术问题；
10、按药品注册报批要求，整理提供相关资料记录，撰写相关申报材料，并对研究结果的真实性和准确性负责；


1、Doctor degree or above major in Pharmacy, Analytical Pharmacology or related.
2、A person with substantial pharmaceutical analysis theories and good operational skills, familiar with analytical equipment and instruments.
3、Familiar with generally used medical websites and databases, liable to perceive regulations, guidance and process for drug R&D, familiar with pharmaceutical technology guidance and registration requirements.
4、Study for analytical methods, validate and transfer the analytical methods, initiate the specifications, study for stability.
5、Responsible for writing the registration dossier and related parts according to the CTD format.
6、Proactive to work, possess good communication and coordination abilities and bear with serious responsibilities.
7、Responsible for the wholly analytical R&D of the program, and undertake the progress management and improvement.
8、Establish the experimental protocol, responsible for formulation selection, research for analytical methods, validate and transfer the analytical methods.
9、Analyze the program technical difficulties, coordinate with Formulation R&D team, resolve difficulties during the stability study, analytical methods validation and transfer, initiate the specifications.
10、Collect and file the related testing data and records, write the related registration dossier according to the requirements of the drug registration application, and should be responsible for the reality and accuracy of the testing results.

952626942