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工作職責(zé):
Responsibilities崗位職責(zé):
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(zhǔn)備項目分析方案、方法、制定分析計劃、批準(zhǔn)項目分析結(jié)果，按照項目方案、SOP，GLP和其他法規(guī)進(jìn)行實驗并匯報結(jié)果。生物分析方法學(xué)包括血藥濃度 （PK）、生物標(biāo)志物 （PD）、抗藥抗體 （ADA）、抗藥抗體中和活性 （NAb）、流式細(xì)胞術(shù)（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(diǎn)控制生物分析項目，并對被任命項目的科學(xué)性、技術(shù)性和合規(guī)性全面負(fù)責(zé)。
3. Communicate with sponsor’s study monitor and provide project updates regularly.
與客戶項目監(jiān)督者進(jìn)行溝通并及時更新項目進(jìn)展。
4. Interact with internal function teams to ensure the completion of the project smoothly.
與內(nèi)部功能組進(jìn)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(biāo)準(zhǔn)操作規(guī)程規(guī)定，審核并批準(zhǔn)每個分析批的分析數(shù)據(jù)。
6. Address QA findings and approve study-related deviations. Perform impact evaluation for deviations and unforeseen events.
處理QA發(fā)現(xiàn)項，批準(zhǔn)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(zhǔn)備并批準(zhǔn)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(jù)SOP和OECD, USFDA, NMPA, ICH, GCP, GLP 法規(guī)和其他適用的法規(guī)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(jīng)過培訓(xùn)獲得免疫化學(xué)PK/PD/ADA主要研究者/專題負(fù)責(zé)人、免疫化學(xué)NAb主要研究者/專題負(fù)責(zé)人、免疫化學(xué)FACS主要研究者/專題負(fù)責(zé)人和/或免疫化學(xué)QPCR 主要研究者/專題負(fù)責(zé)人證書。主要研究者/專題負(fù)責(zé)人所承擔(dān)的方法學(xué)內(nèi)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(guī)要求的培訓(xùn)經(jīng)歷或者工作經(jīng)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(xué)位，生物學(xué)、化學(xué)等相關(guān)專業(yè)，深刻理解免疫化學(xué)原理，（或同等學(xué)歷）， 并具備相應(yīng)的專業(yè)資格認(rèn)證和技能水平，接受過相應(yīng)的GLP/GCP以及SOP培訓(xùn)。
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(dá)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(tuán)隊目標(biāo)為導(dǎo)向的積極分享信息的工作方式和團(tuán)隊協(xié)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(jìn)行良好的溝通交流。
8. Have experience with analytical techniques, particularly immunoassay.
熟悉分析技術(shù)，尤其是免疫分析。