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[?人]???????人??????ҽҩ???޹?˾

  1. ????ʱ?䣺2020-10-14
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? Do the preparatory work before the start of the experiment. (e.g.: the preparation of BR, materials, labels, TAR and so on.); ???ʵ??ǰ??׼??????????????¼??ݡ????ϡ???ǩ????쵥?ȣ??? ? Process scale up from 200L to manufacturing 2000L.Ensure tasks are completed in accordance with approved site procedures, batch records, and protocols??Technology transfer from external part to MSAT; ??????׼?Ĺ?̡?????????¼?ͷ????????200L??2000L?Ĺ??շŴ?ת?ƹ??յ?MSAT???ţ? ? Perform the early and late stage process development and troubleshooting; ???ǰ?ڼ????ڹ??տ????ͽ?????ѣ? ? According to the production process, review and revise the relevant GMP documents; ???????????????ĺ??޸????GMP?ļ??? ? Make the appropriate experimental records during the experiments, cooperate with the teammate to execute protein purification process in accordance with batch record; ?????ڼ䰴Ҫ???¼?????¼?????Ŷӳ?Ա???????μ?¼???????׹??̣? ? Freezer management. (Including 4?棬-20?棬-80?? Freezer), timely completion of qualification and calibration of instruments and equipment; ????4?棬-20?棬-80????䣬??ʱ??????????豸??ȷ?Ϻ?У׼?? ? Summary change control of owner each project, Optimize and improve processes, improve efficiency; ?ܽ?ÿ????Ŀ?ı?????ƣ????Ż??????????Ч?ʣ? ? Participate in a series of related training (operation training and documentation training); ?μӲ??????ļ???ص???ѵ?? ? Other work arranged by superior leaders. ?ϼ??쵼???ŵ???????????
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1. Participate in the daily activities of the Cell Culture Manufacturing Group. Apply proper PPE (Personal Protective Equipment) to all work in the facility; ????ϸ??????????ճ????????Ӧ???ʵ??ĸ??˷?????Ʒȥ????ڳ????ڵ????й????? 2. Participate in the evaluation of new technology, new production process and new production technology; 3. ?????????¹??ա??????????̺????????????? 4. Escalate process issues as necessary to ensure resolution. 5. ??????Ҫ???Ż??????е????Ⲣ??֤??????⡣ 6. Author MFG-CC GMP documents, ensure GMP training requirements are complete and current. ?????????ϸ?????????GMP?ļ???ȷ??GMP??ѵҪ???Լ???ɺ͸??£? 7. Familiar with the handle process of quality events such as deviation, CAPA and change control. ??Ϥƫ?CAPA?ͱ?????????¼??Ĵ??????̣? 8. Ensure operations strictly adhere to all SOPs and cGMP/Quality requirements. ??֤?ϸ???????е?SOPs??cGMP/????Ҫ?????????? 9. Ensure all work is performed in safe manner, the operation complies with EHS requirements and meets the specifications for each service request. ȷ????ȫ?ķ?ʽȥִ?????еĹ?????????????EHSҪ?󣬲????ϸ???????????ı?׼?? 10. Production process monitoring ??review documentation and check all calculations (e.g. batch records, labels, equipment reading). ???????̵ļ?أ??????ļ?????????еļ??㣨????????¼????ǩ???豸?Ķ????ȣ??? 11. Clean and maintain the GMP facility and production equipment, maintenance of environmental and personal hygiene. ????ά??GMP???????????豸,???ֻ????͸????????? 12. Participate in the internal auditing program for company as required; Serve as department representative on cross-functional teams. ??????Ҫ???빫˾???ڲ???Ƽƻ????ܹ????ο?ְ???ŶӵIJ??Ŵ?????
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1. Participate in protein physicochemical analysis??including purity testing??by HPLC,CE??, concentration testing??etc??and biochemical analysis??including Residual HCP, HCDNA, ProteinA testing, etc??; ???뵰??????????????????HPLC,CE???д??ȼ?⣬Ũ?ȼ??ȣ?????????????????????HCP, HCDNA, Protein A ?ȣ??? 2. Participate in analytical method development, qualification and method transfer of physicochemical and biochemical testing; ?????????????????ķ?????????????ȷ?Ϻͷ???ת?ƣ? 3. Perform routine analysis of MSAT as well as other non-GMP samples, including in-process according to SOPs; ????SOPִ??MSAT ??????non-GMP ??Ʒ?ij?????????????п???Ʒ?ȣ? 4. Provide analytical technical support to cell culture , purification and formulation groups in process development trouble shooting, tech transfer and scale-up activities; ??ϸ???????顢???δ???????Ƽ???Ĺ??տ???????????????ת?Ƽ??Ŵ??ṩ????????֧?֣? 5. Perform technical writing assignments such as SOPs, protocols, reports, risk assessments, laboratory investigations, etc. ??????ݼ????ļ???????????̣??ݰ??????棬??????????ʵ???ҵ??鱨??ȣ? 6. Write and review IND, BLA and other regulatory documents; ׫д?????IND,BLA???????????ļ??? 7. Perform analytical data analysis ??data review and trending analysis; ???????ݷ???????????˺????Ʒ????? 8. Other work arranged by superior leaders. ?ϼ??쵼???ŵ???????????
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1. Participate in the daily activities of the purification Manufacturing Group. Apply proper PPE (Personal Protective Equipment) to all work in the facility; ???봿??????ճ????????Ӧ???ʵ??ĸ??˷?????Ʒȥ????ڳ????ڵ????й????? 2. Participate in the evaluation of new technology, new production process and new production technology; ?????????¹??ա??????????̺????????????? 3. Escalate process issues as necessary to ensure resolution; ??????Ҫ?ϱ??????е????Ⲣ??֤??????⣻ 4. Author MGF-DSP GMP documents, ensure GMP training requirements are complete and current; ????????????????GMP?ļ???ȷ????ɺ͸???GMP??ѵҪ?? 5. Familiar with the handle process of quality events such as deviation, CAPA and change control; ??Ϥƫ?CAPA?ͱ?????????¼??Ĵ??????̣? 6. Ensure operations strictly adhere to all SOPs and cGMP/Quality requirements; ??֤?ϸ???????е?SOPs??cGMP/????Ҫ?????????? 7. Ensure all work is performed in safe manner, the operation complies with EHS requirements and meets the specifications for each service request; ȷ????ȫ?ķ?ʽȥִ?????еĹ?????????????EHSҪ?󣬲????ϸ???????????ı?׼?? 8. Clean and maintain the GMP facility and production equipment, maintenance of environmental and personal hygiene; ????ά??GMP???????????豸,???ֻ????͸????????? 9. Participate in the internal auditing program for company as required; Serve as department representative on cross-functional teams; ??????Ҫ???빫˾???ڲ???Ƽƻ????ܹ????ο?ְ???ŶӵIJ??Ŵ????? 10. Other work arranged by superior leaders. ?ϼ??쵼???ŵ???????????
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? Responsible for mammalian cell culture in the shake flask; Familiar with cell thawing, inoculation, subculture and counting; ?????鶯??ϸ????ҡƿ????????Ϥϸ???ⶳ?????֡????????????Ȳ????? ? Familiar with cell banking process; Perform cell growth and viability test for the cell bank; ??Ϥϸ????Ľ??????̣?ִ??ϸ??????????ԣ? ? Understand the cell culture process development and optimization, including the culture medium screening, process development in shake flask and small bioreactor, and the process parameters optimization; Participate in process scale-up and process characterization study; ?˽?ϸ?????????յĿ??????Ż???????????????ɸѡ??ҡƿ??С??Ӧ?????????յĿ????????ղ??????Ż??????빤?շŴ󼰹??ձ????о??? ? Responsible for experimental data recording, results analysis and report preparation; ????ʵ?????ݼ?¼??????????ͱ???׫д?? ? Responsible for the maintenance of the daily used equipment and writting the SOP about equipment operation and maintenance; ????ʵ?????????豸???ճ?ά??????ݹ????豸ʹ?á?ά????SOP?? ? Other work arranged by superior leaders. ?ϼ??쵼???ŵ???????????
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