職位描述
工作職責:
？ 針對在CRO生產的CTA批次提供支持。
Provide local execution support during CTA lot execution at CROs.
？ 按照SOP要求在新建生產車間進行原液生產前準備，工藝放大及臨床批次生產。
Perform standard operating procedures of DS startup/scaleup/clinical lots production in new facility.
？ 在主管的指導下編寫相關文件，如生產批記錄，SOP和驗證報告等。
Author documentation such as batch records, procedures, and validation reports as directed by supervisor.
？ 對關鍵操作提供實時一次正確率支持。
Provide real-time RFT support of critical operations.
？ 與主管一起溝通解決生產操作中的不一致行為。
Work with supervisor to communicate and resolve operational variances.
？ 負責工藝監控，包括工藝參數和工藝數據/趨勢分析的實時回顧。
Process monitoring including real time review of process parameters and process data/trend analysis.
？ 負責部門間和班組間的信息溝通。
Communicate process performance across shifts and departments.
？ 協助主管進行工藝改進，設備能力評估和新技術的使用。
Support supervisor to Implement process enhancements, measure and respond to equipment capability and implement new technologies.
？ 保證操作符合質量安全規章。
Execute operation following QEHS regulations.
？ 參與調查和變更控制，確保變更具有附加價值并且變更后工藝和設備穩定。
Participate investigations, and change controls to ensure changes are value added and processes and equipment are robust.
？ 參與創新文化和持續改進。 主動領導變更能夠提高一次正確率，生產效率和成本減少。
Participate a culture of Innovation and Continuous improvement. Drive changes that support Right First Time, Efficiency, and/or reduced costs.
？ 提供審計支持。
Provide Audit support 。
？ 執行主管分配的其他工作。
Execute other items assigned by supervisor.
？ 根據生產需要進行倒班生產。
Attend shift work according to manufacturing requirement.
任職資格:
？ 教育程度/經驗 Education/Experiences
- 本科以上學歷，藥劑/藥學相關專業。
BS or MS in chemical engineering, biology, biochemistry or other related science or engineering field.
- 有相關工作經驗者優先。
Experience working in related environment is a plus.
？ 特別知識/技能 Specific Knowledge & Skills
- 良好的英語口語和寫作能力
Good English oral and written communication skills are required.
- 熟悉哺乳動物細胞培養或蛋白質純化工藝及溶液配制者優先
Familiarity with mammalian cell culture and/or protein purification process. Solution formulation is not essential, but is highly desirable.
- 熟悉GMP生產為加分項。
Familiarity and experience with a GMP manufacturing environment is a plus.
- 熟悉工業規模生物反應器，連續離心機，層析系統及超濾洗濾系統為加分項
Familiarity with manufacturing-scale bioreactors/fermentors, centrifuge, column chromatography and/or tangential flow filtration (UF/DF) a plus
- 有6西格瑪及5s管理經驗者優先
Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs a plus
