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. 負責生物產品（單抗、雙抗、融合蛋白等）相關理化分析方法的開發，包括但不限于液相色譜、質譜、電泳等，以解決創新項目方法開發的難題；
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方法相關的troubleshooting及一些抗體相關的特殊研究；
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移相關文件。支持分析方法開發、優化、方法確認、方法轉移或驗證工作；
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. 能獨立完成方法轉移、確認、驗證（藥典法規以及文獻閱讀，實驗設計，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.