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Job responsibility: 工作職責:
Job responsibility may include the followings: 工作職責可能包括以下內(nèi)容:
1. Develop or support development of analytical methods for biological molecules (including monoclonal antibodies, multi-specific antibody, ADC, et.) to enable progression of biopharmaceutical development from preclinical to clinical stages.
開發(fā)或支持生物分子(包括單克隆抗體、多特異性抗體、ADC等)分析方法的開發(fā)，以推進生物制藥從臨床前階段到臨床階段的開發(fā)。
2. Perform various analytical sample testing to support development of biological molecules as needed using a variety of Chem-Phys assays. For Chem-Phys assays may include analysis method with HPLC, UPLC, LC-MS, CE, ICIEF, Capliper.
根據(jù)需要， 使用各種化學-物理分析方法進行各種分析樣品測試，以支持生物分子的開發(fā)。理化分析包括HPLC, UPLC, LC-MS, CE, ICIEF, Calipper等分析方法。
3. Write SOP, experimental methods and reports; Support sample preparation, reagent management, stability sample management.
撰寫SOP、實驗方法及報告;支持樣品制備，試劑管理，穩(wěn)定性樣品管理
4. Participate/lead various studies to support CMC development of biological molecules, such as: CQA assessment, comparability study, biological molecular characterization beyond routine testing for product and process understanding and characterization. Support source document preparation including regulatory document authoring/reviewing as needed to support various types of regulatory CMC document submission.
參與/領(lǐng)導各種研究，以支持生物分子的CMC開發(fā)，如: CQA評估，可比性研究，生物分子特性非常規(guī)測試，以理解和表征產(chǎn)品和工藝。支持源文件的準備，包括法規(guī)文件的編寫/審閱，以支持各種類型的法規(guī)CMC文件的提交。
Job Requirement：工作要求
Academic/Professional Qualification學歷/專業(yè)資格
Master's degree or above in Pharmacy, Chemistry, Analytical Chemistry, or Biochemistry; or analytical related excellent professional expertise could be considered.
藥學，化學，分析化學或生物化學專業(yè)碩士或以上學歷；或者在分析專業(yè)領(lǐng)域表現(xiàn)出卓越能力的申請者也可獲得優(yōu)先考慮。
Technical/Skills Required:技術(shù)/技能訓練
1. Be familiar with drug analytical testing, laboratory safety knowledge, analysis.
熟悉藥品檢驗知識、實驗室安全知識、檢驗和儀器分析知識。
2. Be familiar with analytical methods such as SEC，IEC，CE_NR&R, etc.
熟悉分析檢測方法，如尺寸排阻色譜，離子交換色譜，還原&非還原凝膠毛細管電泳等。
3. Be able to experimental design, experiment execution, collect and summarize data, and resolve problems in experiments under supervision and guidance.
可以在監(jiān)督指導下進行實驗設計、執(zhí)行實驗、收集匯總數(shù)據(jù)，可以解決實驗中的問題。
4. Effective verbal and written communication skills.
良好的口頭和書面溝通技巧。
Working Experience: 工作經(jīng)驗
1. At least 3 years of practical experience in Bio-pharmaceutical industry for MS degree.
碩士學歷，醫(yī)藥行業(yè)3年以上生物制藥經(jīng)驗。
2. At least 5 years of practical experience in Bio-pharmaceutical industry for BS degree.
學士學歷，醫(yī)藥行業(yè)5年以上生物制藥經(jīng)驗。
3. Other analytical related excellent professional expertise with more than 8 years of practical experience in Bio-pharmaceutical industry
具備卓越的分析相關(guān)專業(yè)技能，并在生物制藥行業(yè)有超過8 年的經(jīng)驗。
Language Ability， Computer Literacy，etc. :語言能力，電腦知識等
Good English at reading & writing, familiar with basic computer skills.
英語讀寫水平良好，會熟練使用電腦
Others: 其他
1. Proactive and dedicated with a strong sense of responsibility and integrity.
積極敬業(yè)、主動進取、責任心強、正直向上；
2. Competent in organization and coordination, team spirit, analytical skills and problem solving.
有較強的組織協(xié)調(diào)能力、良好的團隊精神、較強的分析和解決問題的能力
3. Good communication skills.
具有良好的溝通表達能力；