英语翻译☆\x05工作经验1.胶体食品安全类药物残留(抗生素)胶体金试纸条的研制、转产及生产相关经验,研发产品在市销售.2.时间分辨产品(双标)转产验证,临床检验及生产相关经验.3.单
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英语翻译☆\x05工作经验1.胶体食品安全类药物残留(抗生素)胶体金试纸条的研制、转产及生产相关经验,研发产品在市销售.2.时间分辨产品(双标)转产验证,临床检验及生产相关经验.3.单
英语翻译
☆\x05工作经验
1.胶体食品安全类药物残留(抗生素)胶体金试纸条的研制、转产及生产相关经验,研发产品在市销售.
2.时间分辨产品(双标)转产验证,临床检验及生产相关经验.
3.单抗、药残检测相关经验.抗原合成、纯化.细胞培养以及动物试验相关经验.
4.抗体纯化,标记(细胞因子FITC,稀土离子Eu、Sm(时间分辨))相关经验.
5.项目管理经验.并有转产验证计划、报告及生产工艺标准操作规程(SOP)文件,产品说明书,产品外包装、产品宣传材料撰写和设计相关经验.
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☆\x05职业目标
1.食品环境安全,病毒微生物检测及生物医药体外诊断试剂的研发及管理.
2.项目研发、转产及管理改进.精细生产.产品质量稳定及持续改进.
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☆ 职业技能
◆ 1.产品研发
(1)食品安全类药物残留(抗生素)胶体金试纸条的研制.
工作内容:
在职过程中完成了恩诺沙星、氯霉素、瘦肉精、氟喹诺酮类等胶体金试纸条产品的研发,部分产品已经上市.
工作中积累了大量的研发经验,尤其在提高产品的灵敏度、稳定性和简化样品前处理步骤、降低样品基质效应等方面有独特的优势.研发的产品从样品处理到结果判读只需10~20min;研发的产品灵敏度居于市场上同类产品的前列(0.2ng).
岗位职责:
1)胶体金新产品的研发
2)生产线的建构和新项目转产
3)工艺规程及相关文件的撰写
4)生产过程中的问题分析
(2)时间分辨试剂盒(双标)产品的研制
工作内容:
一双标转产项目.
包括双标标记物的制备,包被板的制备,增强液的制备及产品其他相关材料的制备.熟悉生产工艺.
项目已经转产验证成功,进入临床验证阶段.
岗位职责:
1)负责研发项目的由研发部转产至生产部生产.负责转产验证计划的撰写,协调人员参与转产验证并负责转产报告的及工艺规程的输出.
2)负责工艺项目的改进和的产品质量稳定和持续改善.
3)生产过程问题分析.
4)原材料及备选材料筛选.
◆ 2.实验操作技能
(1) 熟练掌握单抗和多抗制备流程.并在学校和公司中都参与过抗原合成、小鼠免疫、融合及抗体筛选过程.
(2) 熟练掌握细胞培养、SDS电泳、柱层析、TLC等实验技能.
(3) 抗体纯化及标记技能.掌握腹水、血清初提到精细纯化的步骤.掌握细胞因子FITC标记及纯化,时间分辨检测技术中,Eu标记和Sm标记及纯化技术.
(4) 熟练掌握时间分辨试剂盒各主要组分制备要点,及组分质检思路(国外公司的自检方案和技术).
(5) 熟练掌握动物试验操作技能,如小鼠饲养、免疫、眶下静脉采血,兔颈静脉和心脏采血等操作.
参与公司动物房的规划设计,并制定管理规程和操作规程,并负责培训动物房饲养员.持有试验动物上岗证.
(6) 参加了BioDot技术平台培训,熟练操作BioDot三维喷点仪.负责对新的研发人员和生产操作人员进行实验指导和仪器使用培训.
(7) 熟练运用芬兰wallac公司的全自动时间分辨检测仪Auto 1235及上海新波生物技术有限公司的Anytest 2000等配套时间分辨检测仪器.
◆ 3.生产经验
撰写了研制产品的生产工艺标准操作规程(SOP)文件,产品说明书.参与设计产品外包装、产品宣传材料.
协助建立胶体金试纸产品生产线,负责实现产品由研发到生产的转化,降低产品的批内及批间差异.
良好的沟通能力,独立负责项目,协调人员参与生产.并熟悉ERP流程.有项目改进及产品稳定及持续改善经验.
不必全部翻译,能够描述清楚即可.英语不太好,谢谢大虾们了.
英语翻译☆\x05工作经验1.胶体食品安全类药物残留(抗生素)胶体金试纸条的研制、转产及生产相关经验,研发产品在市销售.2.时间分辨产品(双标)转产验证,临床检验及生产相关经验.3.单
The work experience
1 colloidal food safety drug residue ( antibiotic ) preparation of colloidal gold strip, change the line of production and manufacturing experience, product research and development in the city of sales.
2 time resolved products ( double ), validation, clinical testing and production related experience.
3 monoclonal antibody, drug residue detection related experience. Synthesis of antigen, purified. Cell culture and animal experiments related experience.
4 antibody purification, mark ( cytokine FITC, rare earth ions Eu, Sm ( time resolution) ) experience.
5 project management experience. Production validation plan and report, and the production process of standard operating procedures ( SOP ) file, product brochures, product packaging, promotional materials to compose and design experience.
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The occupation target
1 food and environmental safety, virus detection of microorganisms and biological medicine in vitro diagnostic reagents development and management.
2 R & D projects, change the line of production and management improvement. Fine production. Stability of product quality and continuous improvement.
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The occupation skill
The 1 product development
( 1) food safety drug residue ( antibiotic ) preparation of colloidal gold strip.
Work content:
Working process was completed, chloramphenicol, enrofloxacin clenbuterol, fluoroquinolones and other colloidal gold test strip products R & D, some products already on the market.
Work has accumulated a wealth of experience in research and development, especially in products that improve the sensitivity, stability and simple sample pre-treatment steps, reduce the sample matrix effects and has unique advantages. Research and development of products from the sample treatment to the interpretation of the results is only 10 ~ 20min; R & D products sensitivity in similar products on the market in the forefront ( 0.5 ~ 2ng ).
Job responsibilities:
1) colloidal gold new product development
2) production line and the construction of new project to change the line of production
3) procedure and related document writing
4) the problems in the production process analysis
( 2) time-resolved Kit ( double ) product development
Work content:
A double switching project.
Double markers including preparation, coated board preparation, enhanced liquid preparation and other related materials preparation. Familiar with the production process.
The project had changed the line of production proved to be successful, entering the clinical validation phase.
Job responsibilities:
1) responsible for the project by the R & D department to change the line of production to production. Responsible for production validation plan, coordinate transformation and is responsible for converting the personnel involved in the validation report and the process output.
2) responsible for the project of technology improvement and product quality is stable and continuous improvement.
3) the problem of the production process analysis.
4) raw materials and alternative materials selection.
In 2 experimental operation skills
( 1) Master of monoclonal and polyclonal antibody preparation process. And in schools and companies are involved in synthesis of antigen, immune, fusion and antibody screening process.
( 2) proficiency in cell culture, SDS electrophoresis, column chromatography, TLC and other experimental skills.
( 3) antibody purification and marking skills. Master, first mentioned serum ascites fine purification steps. Master of cytokine FITC labeling and purification, time-resolved detection technology, Eu and Sm markers and purification technology of.
( 4) master the time-resolved kit each major component preparation points, and component inspection train of thought ( foreign company self-test scheme and technical ).
( 5) master the animal test operation skills, such as the mice reared, immune, orbital venous blood sampling, rabbit jugular vein and the blood from heart operation.
Companies involved in the animal room planning and design, and formulate management rules and operating procedures, and responsible for the training of animal house keeper. Holding the test animal certificate.
( 6) in the BioDot technology platform for training, skilled operation BioDot three-dimensional spray apparatus. Responsible for new research and development and production operations staff to carry out experimental instruction and training in the use of equipment.
( 7) skilled use of Wallac Finland automatic time-resolved tester Auto 1235 and the new wave of the Shanghai biological technology limited company Anytest 2000 and other ancillary time-resolved detection instrument.
The 3 production experience
Compose the product development production technology standard operating procedures ( SOP ) file, product brochures. In the design of product packaging, promotional materials.
To assist in the establishment of colloidal gold test paper product line, responsible for the realization of products from research and development to production transformation, reduce product in batch and interassay differences.
Good communication skills, independent and responsible for the project, coordinate the personnel involved in the production. And be familiar with ERP process. Project improvement and product stability and continuous improvement experience