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 residual HCP, residual DNA, residual ProA, mycoplasma test, potency tests which include binding ELISA potency test and cell based potency test, understand technical aspects of the job, best practices, and adhere to cGMP compliance. 執行殘留HCP，殘留DNA，殘留ProA，支原體檢測，酶聯免疫活性和細胞活性實驗的日常檢測，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 residual HCP, residual DNA, residual ProA, mycoplasma test, potency tests which include binding ELISA potency test and cell based potency test. 執行殘留HCP，殘留DNA，殘留ProA，支原體檢測，酶聯免疫活性和細胞活性實驗的方法轉移和方法確認/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，偏差和糾正和預防措施。

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. 本科及三年以上工作經驗，或研究生及一年以上質量控制工作經驗。

3.Strong background in standard and specialized methodologies for biologics products; Experience developing bioassays and biophysical potency assays, developing process impurity assays such as HCP, Residual DNA, and Residual ProA methods is preferred. 具有生物產品方法開發或檢測的相關背景，有生物活性檢測方法和其他生物學實驗方法開發，雜質分析方法開發（如HCP，殘留DNA和殘留ProA方法）的工作經驗者優先考慮； 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。