上海市-浦东新区 | 1人
Responsibilities岗位职责:
1. Act as SD/PI to prepare study protocol/plan, methodology, schedule study progress, approve bioanalytical study results, conduct experiments and report data under study protocol/plan, SOP, GLP and other applicable regulations.
作为SD/PI准备项目分析方案、方法、制定分析计划、批准项目分析结果，按照项目方案、SOP、GLP和其他适用的法规进行实验并汇报结果。
2. Be the single point control of bioanalytical study and have overall responsibility for the scientific, technical and regulatory compliance of assigned studies.
单点控制生物分析项目，并对被任命项目的科学性、技术性和合规性全面负责。
3. Communicate with sponsor’s study monitor and provide timely project updates.
与客户项目监督者进行沟通并及时更新项目进展。
4. Interact with internal function teams to ensure the completion of the project smoothly.
与内部功能组进行沟通，确保整个项目顺利完成。
5. Review and approve analytical data of the analytical runs based on the study protocol, methodology and SOPs.
按照分析方案、方法和标准操作规程规定，审核并批准每个分析批的分析数据。
6. Address QA finding and approve study-related deviations. Perform impact evaluation for deviations and unforeseen events.
回复QA发现项，批准项目偏离。评估偏离与意外事件的影响。
7. Troubleshoot technical issues occurred during conduction of the study.
解决实验中遇到的问题。
8. Prepare and approve final report.
准备并批准项目报告。
9. Perform duties complied with the related SOPs and according to OECD, USFDA and NMPA (Previous CFDA), etc., GLP guidelines as well as other applicable regulations.
根据SOP和OECD, USFDA和NMPA（原CFDA）等GLP 法规和其他适用的法规开展工作。
Requirements岗位要求：
1. Must have experience or be trained with the requirements of USFDA, NMPA (Previous CFDA) and OECD GLP regulations.
必须具备USFDA，NMPA(原CFDA)和OECD GLP 法规要求的培训经历或者工作经验。
2. BS, MS or PhD degree in a scientific discipline with experience or training in chemistry or equivalent experience.
理工科本科、硕士或博士学位，具有化学专业背景、培训经历或同等资历
3. Strong communication skills, including reading, writing and verbal communications, and outstanding interpersonal skill are essential job requirements.
具备工作基本要求的良好的沟通交流能力，包括阅读、书写和口头表达能力以及出色的人际交往技巧。
4. Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives.
必须具备以团队目标为导向的积极分享信息的工作方式和团队协作精神。
5. Proficient in reading, comprehension and writing in English.
具备熟练阅读、理解，书写英语文档能力。
6. Have an engaging and dynamic attitude towards rapid issue resolution and communication.
工作积极热情，可快速解决问题和进行良好的沟通交流。
7. Must be experienced with standard analytical techniques, particularly HPLC, LC-MS, and(or) ICP-MS if necessary.
熟悉标准分析技术，尤其是高效液相色谱，液质联用和（或）电感耦合等离子体技术
（如需要）。
8. Proficient of biological sample pretreatment methods including but not limited to protein precipitation, liquid-liquid extraction and solid-phase extraction.
精通生物样本预处理方法，包括但不限于蛋白沉淀、液液萃取和固相萃取。