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. Bioanalytical methods include Drug concentration (PK), Biomarker (PD), Anti-drug antibody(ADA), Neutralizing Antibody (NAb), Flow Cytometry (FACS) and Quantitative PCR(QPCR).
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和其他法规进行实验并汇报结果。生物分析方法学包括血药浓度 （PK）、生物标志物 （PD）、抗药抗体 （ADA）、抗药抗体中和活性 （NAb）、流式细胞术（FACS）和定量 PCR （QPCR）。
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 project updates regularly.
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 for analytical run acceptability based on study protocol, methodology file 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 findings and approve study-related deviations. Perform impact evaluation for deviations and unforeseen events.
处理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 in the assigned 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, NMPA, ICH, GCP, GLP guidelines as well as other applicable regulations.
根据SOP和OECD, USFDA, NMPA, ICH, GCP, GLP 法规和其他适用的法规开展工作。
Requirements岗位要求：
1. Must be trained to have certificate(s) of Immunochemistry Principal Investigator/Study Director - PK/PD/ADA, Immunochemistry Principal Investigator/Study Director - NAb, Immunochemistry Principal Investigator/Study Director - FACS, and/or Immunochemistry Principal Investigator/Study Director - QPCR. The method(s) that a Principal Investigator/Study Director is responsible for has/have to be matched with the certificate(s) she/he has.
必须经过培训获得免疫化学PK/PD/ADA主要研究者/专题负责人、免疫化学NAb主要研究者/专题负责人、免疫化学FACS主要研究者/专题负责人和/或免疫化学QPCR 主要研究者/专题负责人证书。主要研究者/专题负责人所承担的方法学内容必须与其获得的证书相匹配。
2. Must have experience or be trained with the requirements of OECD, USFDA, NMPA, ICH, GCP, GLP regulations.
必须具备OECD, USFDA, NMPA, ICH, GCP, GLP 法规要求的培训经历或者工作经验。
3. BS degree or above in Biology, Chemistry or related- science discipline with strong understanding of immunoassay principles, and have received proper GLP/GCP and SOPs training.
本科或以上学位，生物学、化学等相关专业，深刻理解免疫化学原理，（或同等学历）， 并具备相应的专业资格认证和技能水平，接受过相应的GLP/GCP以及SOP培训。
4. 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。
5. 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。
6. Be skillful at reading, understanding and writing English documentation.
熟练阅读、理解和书写英文文档。
7. Have an engaging and dynamic attitude towards resolve issues rapidly and clear communications.
工作积极热情，可快速解决问题和进行良好的沟通交流。
8. Have experience with analytical techniques, particularly immunoassay.
熟悉分析技术，尤其是免疫分析。