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ZoeyZhao新虫 (小有名气)
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[交流]
Technology Services and Transfer leader（ Director/Assistant Director）
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【Role & Responsibilities】 1.Responsible for scale-up & Technical assessment from R&D to Pilot plant for early stage projects. 2.Responsible for organizing the cross functional team meetings before scale-up for process feasibility evaluation, Process safety assessment based on plant scale, analyzing the operational feasibility at plant Scale, Material management etc. 3.Responsible for ensuring the cGMP practices and safety, training the personnel etc. 4.Role includes the co-ordination with R &D Team for Initial documents preparation like BPR etc. 5.Providing the support for site activation service targets (e.g. cost, quality and time) and the effective development and implementation of the systems, processes that focused customer focused solutions and delivery excellence. 6.Support compliance to applicable quality system guidelines and regulations. Coordinate the development of action plans when CAPA are required and implement in timely manner. 7.Analyzing the Production Process & eliminating the process issues during scale up. 8.Identifying improvement opportunities include Throughput, Productivity, Overall Plant Effectiveness, Quality, yield etc., 9.Developing the new technology in the system for improving the process efficiency and cost reduction. 10.Providing the support for Grass root preparations for regulatory inspections，vendor & Customer audits. 【Desired Skills】 1.Knowledge in Process development & pilot plant operations. 2.Experienced in hazard assessment for Intermediates/API’s from the bench scale to full scale manufacturing, including handling exothermic reactions, Thermal Stability for chemicals, Thermal hazard of synthesis (Calorimetric techniques). 3.Basic understanding of Design of experiments and modeling, Risk assessment. 【Requirements】 1.MS/PHD in Chemical engineering/Organic Chemistry from an accredited university, PhD is preferable. 2.7-12 years of experience in Pharmaceutical industry in R&D domain and pilot plant operations. 3.Strong written and oral communication skills. 4.Working knowledge in English is preferable. Zoey Zhao Mail: zoeyzhao@sipyun.com WeChat :Zoey_ypb [ 来自版块群 天津 ] |
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