MST Group Leader to Director 无锡

月薪： 1-2万/月

该公司所有职位
  • 5-7年经验
  • 招若干人
  • 11-09 发布

职位描述

职位描述： 职位描述：Responsibilities:A. Tech Transfer Lead & Functional Leader1. Lead and complete the new production introduction assessment.2. Partner with Process Development to ensure successful process transfer.3. Monitor the manufacturing process, when the situation is needed need to be observe or provide recommendation on-site.4. Serve as a reviewer of tech transfer protocol, MBR, PFD, manufacturing related documentation, etc.5. Attend project meetings.B. Upstream, Downstream, and Formulation, Fill and Finishing Process Science1. Perform the satellite run activates including upstream and downstream.2. Lead cross functional technology transfer teams for upstream and downstream operations.3. Serve as the science and technical expert during the tech transfer, gap analysis, troubleshooting of manufacturing processes4. Perform satellite run upstream and downstream activates and analysis5. Design and perform deviation related experiments to determine and understand the possible cause factors that related to the event.6. New manufacturing equipment evaluation design and planning.7. Lead cross functional technology transfer teams for aseptic formulation and sterile filling and finishing operations.C. Process Performance Qualification1. Lead PPQ/PV (process performance qualification or process validation) preparations & execution;2. Participate/contribute to PC (process characterization).D. Deviation In vestigation1. Lead or participate in key investigations of deviations.?2. Communicate with the client regarding the deviation investigation results.?3. Investigate, identify root cause, and identify CAPA for manufacturing deviations.Basic Qualifications:?Education and working experience.- Category1: B.S. in Biology, Biochemistry, Chemistry, Biochemical engineering, Chemical Engineering, and Life Science related majors, with 2-5 years pharmaceutical, manufacturing, QC, QA, Process Development, Food science related experience.- Category2: M.S. in Biology, Biochemistry, Chemistry, Chemical Engineering, and Life Science related majors, with 2-5 years pharmaceutical, manufacturing, QC, QA, Process Development, Food science, related experience.- Category 3: M.S. or Ph.D. in Biology, Biochemistry, Chemistry, Chemical Engineering, and Life Science related majors, with 5＜ years pharmaceutical, manufacturing, QC, QA, Process Development, Food science, related experience.?Strong written, reading, and oral English communication skills.?Must be able to work within multifunctional teams.?Ability to define problems, collect data, establish facts, and draw valid conclusions.?Ability to effectively present information to top management, public groups, and/or boards of directors.?Familiar with cGMP and CMC.?Author technical reports and protocols in support of cGMP activities.?Management and manufacturing experience is preferred someone with over 8 years’ experience. 职能类别： 生物工程/生物制药

联系方式

无锡滨湖区马山梅梁路108号

公司信息

使命 我们的使命是转变和加快制药发现、开发及在快速成长的生物制剂领域造福全球患者。 公司简介 药明生物技术（药明康德关联公司）提供全面、综合及可高度订制的生物制剂发现，开发及生产服务。我们是世界上唯一的开放式生物制剂技术平台，提供端到端解决方案，让任何人能从概念到商业化生产过程中发现、开发及生产生物制剂。我们提供的单源式服务为客户节省了宝贵的项目时间和费用。我们公司的历史和成就证明了我们为全球客户提供真正的一站式，开放式服务的价值主张和承诺。 更多信息，请登录公司官网：http://www.wuxibiologics.com.cn/

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企业入驻日期： 2017-11-09

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