職位描述
工作職責(zé):
？ 針對在CRO生產(chǎn)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(chǎn)車間進(jìn)行原液生產(chǎn)前準(zhǔn)備，工藝放大及臨床批次生產(chǎn)。
Perform standard operating procedures of DS startup/scaleup/clinical lots production in new facility.
？ 在主管的指導(dǎo)下編寫相關(guān)文件，如生產(chǎn)批記錄，SOP和驗(yàn)證報告等。
Author documentation such as batch records, procedures, and validation reports as directed by supervisor.
？ 對關(guān)鍵操作提供實(shí)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(fù)責(zé)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(shí)時回顧。
Process monitoring including real time review of process parameters and process data/trend analysis.
？ 負(fù)責(zé)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(jìn)行工藝改進(jìn)，設(shè)備能力評估和新技術(shù)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(shè)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(jìn)。 主動領(lǐng)導(dǎo)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(jìn)行倒班生產(chǎn)。
Attend shift work according to manufacturing requirement.
任職資格:
？ 教育程度/經(jīng)驗(yàn) Education/Experiences
- 本科以上學(xué)歷，藥劑/藥學(xué)相關(guān)專業(yè)。
BS or MS in chemical engineering, biology, biochemistry or other related science or engineering field.
- 有相關(guān)工作經(jīng)驗(yàn)者優(yōu)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(xì)胞培養(yǎng)或蛋白質(zhì)純化工藝及溶液配制者優(yōu)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(chǎn)為加分項(xiàng)。
Familiarity and experience with a GMP manufacturing environment is a plus.
- 熟悉工業(yè)規(guī)模生物反應(yīng)器，連續(xù)離心機(jī)，層析系統(tǒng)及超濾洗濾系統(tǒng)為加分項(xiàng)
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(jīng)驗(yàn)者優(yōu)先
Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs a plus
