崗位職責:
1.Assist risk assessment before and during technical transfer.
協助技術轉移的風險評估。
2.Draft and review the technical transfer documents such as commercial-scale process description and technical reports.
起草和審核技術轉移文件,例如商業化規模工藝描述、技術報告。
3.Draft and review process validation related documents such as process validation protocols and process validation reports.
起草和審核工藝驗證相關文件,例如工藝驗證方案、報告。
4.Draft and review process validation supporting study protocols and reports. Execute supporting studies and investigate discrepancies.
起草和審核工藝驗證支持性研究的方案、報告。執行支持性研究,調查差異。
5.Responsible for process data collection and analysis.
負責工藝數據的收集和分析。
6.Responsible for setting up programs and process parameters for manufacturing equipment.
負責生產設備的工藝程序和工藝參數的設定。
7.Participate in the quality management activities, including the self-inspection, internal audit, external audit, deviations investigation and risk assessment of process change. Support for manufacturing related deviation investigation and change application. Responsible for drafting and reviewing of technical reports and memorandums.
參與質量管理活動,包括自檢、內審、外審、偏差調查、工藝變更相關的風險評估。支持生產相關偏差的調查和變更申請。負責技術報告或備忘錄的起草和審核。
8.Assist in collecting and trending product quality data and in-process data in each manufacturing batch. Draft and review manufacturing batch summary reports.
協助對與產品質量有關的批生產產品質量數據和工藝的數據進行匯總和趨勢分析。起草并審核批生產總結報告。
9.Responsible for drafting, revising, delivering and retrieving the MST documents.
負責完成MST相關文件的維護包括文件的新建、升版、發放和回收。
10.Support the CMC submission work, including drafting and reviewing the process-related filling documents, and providing relevant data and reports.
支持CMC申報工作,包括起草和審核工藝相關的注冊文件,以及提供相關文件和報告。
任職要求:
工作經驗: 3年或以上
專業知識/技能:生物工程、生物化學、藥劑學、制藥或相關專業。
語言能力:良好的英文讀寫水平,聽說佳
其他要求:
1.Proven ability to effectively collaborate with internal and external partners.
具備與內部或外部伙伴有效合作的能力。
2.Demonstrated excellence in technical writing in bilingual (Chinese and English).
在中英雙語技術文件寫作方面表現出色。
3.Fluent English in reading, writing, speaking is mandatory.
需具備良好的英文閱讀、寫作和口語交流能力。
4.Understanding of basic commercial-scale production process and production techniques is preferred.
了解商業化生產基本工藝和生產技術優先。
5.Understanding of common practice of biopharmaceutical process development, technical transfer and process validation is preferred.
了解工藝開發、技術轉移和工藝驗證的通常做法優先。
6.Understanding of basic the GMP system is preferred.
了解基本的GMP體系優先。
7.Understanding of basic design of experiment (DoE) and statistics is preferred.
了解基本的實驗設計和統計分析知識優先。
8.Good communication skills.
良好的溝通能力。
9.Proficient in using Office computer software such as Word, Excel and Power Point; knowledge in statistical analysis software, e.g., JMP, minitab, is preferred.
熟練使用辦公軟件,如Word, Excel, Power Point等;有統計分析軟件知識者優先,例如JMP、minitab。