邹全飞 Email & Phone Number

中国 上海市

主要负责non-GLP和GLP生物分析工作的管理，以支持新药开发，具体工作有:1，独立对接和管理CRO，以保证工作按照方案和知道原则等完成2，负责审阅和解释生物分析相关的数据和文档3，管理工作过程中产生的相关文档4，对实验室进行现场质量控制，监督工作质量，并跟踪发现项的预防纠正措施等5.支持公司NDA申报工作，主要参与部分文件整理、质控等工作。6.负责临床项目生物分析部分的核查准备工作（IRMP），审核项目相关资料，结合实验室审核，评估项目风险，对于可能对项目产生影响的问题准备应对措施

中国 上海

1. Lead or participate the development and validation of LCMSMS based bioanalytical methods for PK, PD, biomarkers area, etc. Perform study design for method validation and sample analysis followed GLP.2. Effectively communicate with sponsor/client's study monitor, vendors, coworkers or supervisors with study issue, including progress updates, plan/protocals, reports, etc.3. Draft or review study plan/protocal and study report. Track the study documentation progress.4. Cooperate with other teams to ensure to meet the project quality and timeline.5. Familiar with pharmaceutical industry regulations and NMPA/FDA/ICH guidelines6. Responsible for the trouble-shooting in method development or sample analysis.7. Responsible for new employee going into job training. Assist leaders to manage instruments maintainence

上海

Responsible formethod development and sample analysis of various NCEs, including compoundswith high polar, weak polar, and endogenous compounds with LC-MS/MS. Work as aprimary researcher of IND study, in charge of method development and validationof interest compound, as well as analysis of the biological samples.