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崗位職責：

1. 負責重組蛋白、抗體等生物藥理化分析方法檢測工作，如SEC、CEX、CE-SDS、iCIEF、肽圖、N-糖型、吐溫等包括但不限于；

Responsible for the detection of biochemical analysis methods for recombinant proteins and antibodies, such as SEC, CEX, CE-SDS, iCIEF, peptide map, N-glycan profile, PS80/20, etc.

2. 負責生物產(chǎn)品（單抗、雙抗、融合蛋白等）相關(guān)理化分析方法的開發(fā)，包括但不限于液相色譜、質(zhì)譜、電泳等，以解決創(chuàng)新項目方法開發(fā)的難題；

Responsible for the development of physicochemical analysis methods related to biological products (monoclonal antibody, double antibody, fusion protein,etc.), including but not limited to liquid chromatography, mass spectrometry,electrophoresis, etc., to solve the problem of innovative project method development;

3. 支持QC方法相關(guān)的troubleshooting及一些抗體相關(guān)的特殊研究；

Support troubleshooting related to QC method and some special research related to antibodies.

4. 負責撰寫檢測方法SOP、各類研究方案和報告以及方法驗證和轉(zhuǎn)移相關(guān)文件。支持分析方法開發(fā)、優(yōu)化、方法確認、方法轉(zhuǎn)移或驗證工作；

Responsible for writing test method SOP, various research programs and reports, as well as method validation and transfer related documents; Support analysis method development, optimization, method validation, method transfer or verification;

5. 支持異常事件的調(diào)查和研究工作；

Support the investigation and research of abnormal events;

6. 承擔項目管理工作，根據(jù)公司項目進度按時推進本部門的工作，包括但不限于文件體系的管理以及設(shè)備驗證及日常維護工作；

Responsible for project management, according to the company's project schedule to promote the department's work on time, including but not limited to file system management, equipment verification and daily maintenance。

7. 符合環(huán)保、健康和安全的方針政策；

Comply with environmental, health and safety policies；

8. 完成上級安排的其他工作。

Complete other tasks assigned by superiors.

任職要求：

1、藥學、化學、生物學或相關(guān)學科碩士或以上學歷；

College degree or above in Pharmacy, chemistry, biology or related discipline；

2. 能獨立完成方法轉(zhuǎn)移、確認、驗證（藥典法規(guī)以及文獻閱讀，實驗設(shè)計，報告匯總）；

Be able to independently complete method transfer, validation and verification (pharmacopoeia regulations and literature reading, experimental design, report summary);

3. 熟悉GMP體系中QC的工作要求；

Familiar with QC requirements in GMP system.

4. 精通偏差、OOS/OOT、等實驗室異常調(diào)查流程；

Proficient in deviation, OOS/OOT, and other laboratory anomaly investigation processes.

5. 具有較強的團隊合作意識，具有較好的溝通交流能力，具有一定的抗壓能力。

Have a strong sense of teamwork, good communication skills, have a certain ability to work under pressure.