1. Generate all necessary test procedure, perform analysis of in-process sample, drug substance, drug product and stability study sample under cGMP standards. 撰寫所有必須的檢測規程，根據檢測規程，依照相關cGMP標準對中間樣品，原液，制劑和穩定性樣品進行分析檢測； 2.Perform routine testing such as pH, osmolality, UV, visible particle, Sub-visible particle, extractable volume, color, clarity, LC related assay, CE related assay, understand technical aspects of the job, best practices, and adhere to cGMP compliance. 執行pH, 滲透壓，蛋白濃度，可見異物，不溶性微粒，裝量，顏色，濁度，液相相關和毛細管電泳相關的日常檢測，理解工作的技術原理，最佳做法，并遵守cGMP合規性； 3.Generate method transfer/qualification/validation protocol under ICH/USP/EP/CP guidelines, and draft method transfer/qualification/validation report after the completion of experiment. 根據ICH/USP/EP/CP指南生成方法轉移/確認/驗證方案，實驗執行完成后起草方法轉移/確認/驗證報告； 4.Execute method transfer/qualification/validation of as pH, osmolality, UV, extractable volume, color, clarity, LC related assay, CE related assay. 執行pH, 滲透壓，蛋白濃度，裝量，顏色，濁度，液相相關，毛細管電泳相關的檢測方法的轉移和方法確認/驗證； 5.Perform moderate data analysis and trending, document work according to GMP and notify management. 進行適當的數據分析和趨勢分析，根據GMP進行文件工作并通知管理人員； 6.Handle the quality event such as change control, deviation and CAPA related to the testing. 負責處理與檢測相關的質量事件，例如變更，偏差和糾正及預防措施； 7. Stability study administrator which in charge of stability protocol/report preparation and storage/management of stability sample. 穩定性研究管理主要負責編寫穩定性方案和報告，穩定性樣品存儲和管理。 8.Sample administrator which mainly responsible for sample receipt/ storage/distribution/disposal, test report and CoA issuance. 樣品管理主要負責樣品接收，存儲，分發和銷毀，分析檢測報告的出具。 Qualification 任職資格： 1.Bachelor’s/Master’s degree. 本科/碩士。

2.Bachelor’s degree in a scientific discipline with 3+ years’ experience in quality control systems, or Master’s degree with 1+ years’ experience.

3.Extensive experiences in analytical testing for protein analysis, such as HPLC, CE, MS, iCE3，UV, extensive experience in method development,qualification, validation and method transfer of physical-chemical methods. 具有蛋白質分析測試方面工作經驗，如高效液相色譜、毛細管電泳、質譜、ICE3、紫外掃描等；對理化分析方法的方法開發、確認、驗證和方法轉移方面有豐富經驗。 4.Understanding of FDA and ICH guidelines as well as GLP/GMP principles associated with analytical development, the basic statistics required in data analysis. 了解FDA和ICH指南以及與分析方法開發相關的GLP / GMP原則和數據分析所需的基本統計學。 5.Highly motivated, flexible, and multi-task. 高度積極性，靈活性和多任務解決能力。 6.Excellent verbal and written communication skills in English. 有良好的英語口語和寫作能力。