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工作職責:
Responsibilities崗位職責:
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).
作為SD/PI準備項目分析方案、方法、制定分析計劃、批準項目分析結果，按照項目方案、SOP，GLP和其他法規進行實驗并匯報結果。生物分析方法學包括血藥濃度 （PK）、生物標志物 （PD）、抗藥抗體 （ADA）、抗藥抗體中和活性 （NAb）、流式細胞術（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.
單點控制生物分析項目，并對被任命項目的科學性、技術性和合規性全面負責。
3. Communicate with sponsor’s study monitor and provide project updates regularly.
與客戶項目監督者進行溝通并及時更新項目進展。
4. Interact with internal function teams to ensure the completion of the project smoothly.
與內部功能組進行溝通，確保整個項目順利完成。
5. Review and approve analytical data for analytical run acceptability based on study protocol, methodology file and SOPs.
按照分析方案、方法和標準操作規程規定，審核并批準每個分析批的分析數據。
6. Address QA findings and approve study-related deviations. Perform impact evaluation for deviations and unforeseen events.
處理QA發現項，批準項目偏離。評估偏離與意外事件的影響。
7. Troubleshoot technical issues occurred in the assigned study.
解決實驗中遇到的問題。
8. Prepare and approve final report.
準備并批準項目報告。
9. Perform duties complied with the related SOPs and according to OECD, USFDA, NMPA, ICH, GCP, GLP guidelines as well as other applicable regulations.
根據SOP和OECD, USFDA, NMPA, ICH, GCP, GLP 法規和其他適用的法規開展工作。
任職資格:
Requirements崗位要求：
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.
必須經過培訓獲得免疫化學PK/PD/ADA主要研究者/專題負責人、免疫化學NAb主要研究者/專題負責人、免疫化學FACS主要研究者/專題負責人和/或免疫化學QPCR 主要研究者/專題負責人證書。主要研究者/專題負責人所承擔的方法學內容必須與其獲得的證書相匹配。
2. Must have experience or be trained with the requirements of OECD, USFDA, NMPA, ICH, GCP, GLP regulations.
必須具備OECD, USFDA, NMPA, ICH, GCP, GLP 法規要求的培訓經歷或者工作經驗。
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.
本科或以上學位，生物學、化學等相關專業，深刻理解免疫化學原理，（或同等學歷）， 并具備相應的專業資格認證和技能水平，接受過相應的GLP/GCP以及SOP培訓。
4. Strong communication skills, including reading, writing and verbal communications, and outstanding interpersonal skill are essential job requirements.
具備工作基本要求的良好的溝通交流能力，包括閱讀、書寫和口頭表達能力以及出色的人際交往技巧。
5. Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives.
必須具備以團隊目標為導向的積極分享信息的工作方式和團隊協作精神。
6. Be skillful at reading, understanding and writing English documentation.
熟練閱讀、理解和書寫英文文檔。
7. Have an engaging and dynamic attitude towards resolve issues rapidly and clear communications.
工作積極熱情，可快速解決問題和進行良好的溝通交流。
8. Have experience with analytical techniques, particularly immunoassay.
熟悉分析技術，尤其是免疫分析。