Senior QC Technician (Biotechnology Company)

刷新于 7 个月前
20 查看
5 申请
上海
分享
职位职责
Senior QC Technician (Biotechnology Company)COMPANY OVERVIEWShanghai JW Biotechnology Co., Ltd. (JW) is a biotechnology company dedicated to pursue innovative technology to develop cures for people with serious and life-threatening diseases.JW has obtained exclusive licenses of multiple patents and other intellectual property owned by the Pasteur Institute and Theravectys for development, manufacture and commercialization of therapeutic products based on lentiviral vectors.We offer lentiviral vector development, manufacturing and analytical testing for clinical and commercial supply. Our services include Process and Analytical Methods Development, Full GMP Production, with USP and DSP, Fill & Finish, Quality Control & Quality Assurance and Regulatory Support. The GMP production facility located in Shanghai is dedicated to provide safe and reliable viral vector-based products and CMO/CDMO services, helping to translate early stage research into commercially viable therapies.In addition, JW has established partnership with the Huashan Hospital to develop leading edge therapies for various cancers such as liver and prostate cancersas well as infectious diseases such as HBV and Tuberculosis.Senior QC Technician is responsible for routine QC testing on raw materials, in-process and release samples. This position will support method qualification activities including authoring protocols/reports and execution of testing and will support investigational new drug (IND) activities. We are looking for expertise in ELISA, in-vitro potency and qPCR methods.Collaborate with cross functional teams including Manufacturing, Warehouse and Quality Assurance.Responsibilities• Develop, perform, troubleshoot, and optimize AAV characterization assays including but not limited to qPCR and ELISAs • Establish and qualify assay controls, standards, and references• Maintain cell lines used for cell-based assays.• Maintain complete and accurate records of all work performed• Author and/or review IQ, OQ, PQ protocols and reports as well as standard operating procedures.• Ensure maintenance and calibration of equipment including controlled temperature environments, analytical equipment, pipettes, etc.• Ensure laboratory supplies and required inventory are maintained• Manage contract testing lab relationships: coordinate sample shipments, obtain results, and follow up on open action items• Document, technically evaluate, interpret data, and trend results• Review data for quality, consistency, and accuracy• Write technical protocols and reports• Perform method transfers, method qualifications etc. per approved protocol• Conduct laboratory investigations as required• Identify gaps, recommend process improvements, and implement changes• Participate in continuous improvement projects and activities• Mentor new hires• Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility and products manufactured• Document writing such as: laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.Best regardsDavid
职位要求
Requirements• Bachelor’s Degree in Biochemistry, Molecular Biology, or other relevant disciplines in life sciences AND 5 or more years of hands-on experience in QC laboratory environment OR• Master’s Degree in Biochemistry, Molecular Biology, or other relevant disciplines in life sciences AND 3 or more years of hands-on experience in QC laboratory environment• Strong knowledge of QC testing principles and procedures in cell culture (aseptic technique), cell-based assays, qPCR, ELISA, DNA\RNA extraction etc.• Experience with cGMP environments and audits• Knowledge of equipment protocols and requirements• Good laboratory documentation skills and protocol writing and revision experience• Strong interpersonal and communication skills; written and oral• Outstanding planning, organization, and multitasking skills• Team player and meet project timelines• Experience or knowledge of a wide range of analytical instrumentation with the ability to troubleshoot and monitor system suitability trends.• Wiling to relocate to ChinaPreferred Qualifications• Understanding of applicable regulatory requirements (21 CFR, USP, EP, ICH)
搜索你理想的职位
职位类别
城市或国家
也看过
Hollywood Shanghai now is Recruiting
Hollywood Shanghai
15000 人民币~20000 人民币/每月
上海
保存职位
0 查看
0 申请
刷新于 3 小时前
Spanish Chef Needed in Shenzhen
New Spanish Restaurant
15000 人民币~20000 人民币/每月
深圳
保存职位
0 查看
0 申请
刷新于 3 天前
Portuguese Speaking Customer Service Representative
Motion Global
15000 人民币~20000 人民币/每月
上海
保存职位
0 查看
0 申请
刷新于 14 天前
Sales(Full-time)
深圳市人本时装有限公司
15000 人民币~20000 人民币/每月
深圳
保存职位
0 查看
0 申请
刷新于 3 个月前
电子元器件销售(韩语)Electronic Components Sales (Korean)
Shenzhen Yuhong Industrial Co., Ltd.
15000 人民币~20000 人民币/每月
全职
深圳
保存职位
0 查看
0 申请
刷新于 5 个月前
High school A level Physics teacher needed in Nanjing city, Jiangsu province
Nanning Zest Global HR Co.,Ltd.
25000 人民币~30000 人民币/每月
全职
南京
保存职位
0 查看
0 申请
刷新于 7 个月前
OuBao Hotel
Hainan Silk Road United Foreign Talent Exchange Service Ltd.,Co.
海口
保存职位
0 查看
0 申请
刷新于 7 个月前
Quality Management Engineer
Desay SV
15000 人民币~20000 人民币/每月
全职
support.area.overseas
保存职位
0 查看
0 申请
刷新于 8 个月前
Latvia language teacher
Aviation and Tourism Department
5000 人民币~10000 人民币/每月
全职
石家庄
保存职位
0 查看
0 申请
刷新于 10 个月前
Foreign English Teacher
Kunshan Junmei English Training Center
15000 人民币~20000 人民币/每月
全职
南京
保存职位
0 查看
0 申请
刷新于 1 年前

最新博客

职位
人才
博客
我的