主要職責Job Description:
1、依據GMP規范開展無菌條件下細胞搖瓶培養操作；
Responsible for conducting sterile cell culture in shake flasks under GMP guidelines;

2、熟練操作生物安全柜、振蕩培養箱、細胞計數儀、臺式離心機等實驗設備；
Proficient in operating biosafety cabinets, orbital shakers, cell counters, benchtop centrifuges and related instruments;

3、對生產過程中發生的偏差進行處理，完成根本原因分析并實施糾正與預防措施；
Handle production deviations, conduct investigations, and implement corrective and preventive actions (CAPA);

4、編制變更控制及工藝驗證方案，依照方案執行相關工作并撰寫總結報告；
Prepare change control and process validation protocols, carry out associated tasks according to the plans, and generate reports;

5、編寫與設備、工藝流程及運行管理相關的標準操作規程；
Draft standard operating procedures related to equipment, manufacturing processes, and operational activities;

6、負責GMP生產區域的環境管控，按文件規定完成設備的清潔與消毒作業；
Responsible for maintaining the environment in GMP production areas and performing equipment cleaning and disinfection as per documented procedures;

7、及時、準確、規范地填寫批生產記錄、設備使用日志等各類原始記錄；
Timely, accurately, and properly complete batch production records, equipment usage logs, and other relevant documentation;

8、開展生產數據統計分析，提出物料需求，并參與采購執行及到貨驗收；
Conduct statistical analysis of production data, submit material requirements, and participate in procurement and receiving processes;

9、協助質量保證部門完成內部審計、客戶審計以及官方監管機構的檢查工作；
Support QA in completing internal audits, client audits, and inspections by regulatory authorities;

10、接收新工藝技術，完成工藝評估及從小試到中試的放大研究。
Receive new processes, perform process evaluation, and conduct scale-up from lab to pilot scale.

任職要求Job Requirement:
1、生物工程、分子生物學、微生物學、化學工程、藥學等相關專業，本科及以上學歷；
Biological engineering, molecular biology, microbiology, chemical engineering, pharmacy or related fields, bachelor's degree or above;

2、具備CHO細胞無菌培養的實際操作經驗；
Hands-on experience in sterile culture of CHO cells;

3、熟悉GMP等法規要求，具有FDA、cGMP認證經歷者優先考慮；
Familiar with GMP and related regulatory requirements, prior experience with FDA or cGMP certification is preferred;

4、工作態度嚴謹細致，具備較強的責任意識和團隊協作能力；
Demonstrate meticulous work attitude, strong sense of responsibility, and good team cooperation spirit;

5、具備基本的英語應用能力，能夠滿足日常工作中讀寫交流需要。
Possess basic English proficiency to support daily communication, reading, and writing tasks.