職位描述
工作職責:
參與原液下游蛋白質(zhì)純化生產(chǎn)操作，包括但不限于緩沖液制備，AKTA純化系統(tǒng)操作，低pH病毒滅活操作，除病毒過濾操作，超濾洗濾操作和最終原液分裝。。執(zhí)行生產(chǎn)、確認和驗證工作，包括產(chǎn)品生產(chǎn)操作、車間清潔和產(chǎn)品切換清潔、設備操作、溶液配制、生產(chǎn)批記錄審核和特殊樣品協(xié)調(diào)。對問題解決、技術轉移和投產(chǎn)準備提供支持。協(xié)助主管執(zhí)行偏差調(diào)查、工藝數(shù)據(jù)分析和工藝過程改進工作。對工藝實驗設計提供生產(chǎn)支持，如混合系統(tǒng)、產(chǎn)品轉移和其他相關生物過程控制系統(tǒng)等。能夠制備并介紹技術分享資料。了解cGMP需求和安全操作要求，并且針對內(nèi)部和外部審計提供審計支持。
Participate in the execution of drug substance downstream protein purification processes, include but are not limited the following activity: the buffer preparation, AKTA process system operation, low pH viral inactivation operation, viral removal operation, UFDF operation and final filling operation. Execute manufacturing and qualification/validation activity, including product operations, suite clearance and changeover, equipment processing, solution formulation, manufacturing batch record review and special sample coordination. Provide support in troubleshooting activities, technology transfer and start-up activities. Support supervisor to execute investigations, analyze process data and identify and implement process improvements. Provide support of process of experimental design with regard to system mixing, mass transfer, and other pertinent aspects of bioprocess system control. Author and present comprehensive technical presentations and procedures. Thorough understanding of cGMP requirements and safety practices and provide audit support to several internal and external audits.
主要職責 Role Responsibilities
？ 在SOP的指導下，進行原液的下游蛋白質(zhì)純化生產(chǎn)操作。包括但不限于緩沖液制備，AKTA純化系統(tǒng)操作，低pH病毒滅活操作，除病毒過濾操作，超濾洗率操作和最終原液分裝。
Perform DS downstream protein purification manufacturing under standard operation procedure, include but are not limited the following activity: AKTA process system operation, low pH viral inactivation operation, viral removal operation, UFDF operation and final filling operation.
？ 按照SOP要求在新建生產(chǎn)車間進行原液下游蛋白質(zhì)純化生產(chǎn)前準備，工藝放大及臨床批次生產(chǎn)。
Perform standard operating procedures of DS downstream protein purification startup/scale up/clinical lots production in new facility.
？ 在主管的指導下編寫相關文件，如生產(chǎn)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(chǎn)操作中的不一致行為。
Work with supervisor to communicate and resolve operational variances.
？ 負責工藝監(jiān)控，包括工藝參數(shù)和工藝數(shù)據(jù)/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(xié)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(zhì)量安全規(guī)章。
Execute operation following QEHS regulations.
？ 參與調(diào)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(wěn)定。
Participate investigations, and change controls to ensure changes are value added and processes and equipment are robust.
？ 參與創(chuàng)新文化和持續(xù)改進。 主動領導變更能夠提高一次正確率，生產(chǎn)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(zhí)行主管分配的其他工作。
Execute other items assigned by supervisor.
？ 根據(jù)生產(chǎn)需要進行倒班生產(chǎn)。
Attend shift work according to manufacturing requirement.
任職資格:
教育程度/經(jīng)驗 Education/Experiences
？ 本科及以上藥學、化工、生物、生物化學及其他相關專業(yè)。
BS or MS in chemical engineering, biology, biochemistry or other related science or engineering field.
？ 有相關工作經(jīng)驗。
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.
？ 熟悉蛋白質(zhì)純化工藝及溶液配制者優(yōu)先
Familiarity with protein purification process. Solution formulation is not essential, but is highly desirable.
？ 熟悉GMP生產(chǎn)為加分項。
Familiarity and experience with a GMP manufacturing environment is a plus.
？ 熟悉工業(yè)規(guī)模層析系統(tǒng)及超濾洗濾系統(tǒng)為加分項
Familiarity with manufacturing-scale column chromatography and/or tangential flow filtration (UF/DF) a plus
？ 有6西格瑪及5s管理經(jīng)驗者優(yōu)先
Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs a plus
