固体制剂新产品导入工程师

通过以下工作，确保新产品的顺利落地，在商业化生产前解决工艺存在问题，杜绝商业化生产中工艺问题的出现。 Through the following work, ensure the smooth landing of new products, solve process problems before commercial production, and eliminate process problems in commercial production. 1. 参与日常的CMC处方工艺开发会议。 Attend the routine CMC DP formulation and process development meeting. 2. 全程参与新产品从CMC实验室/车间向工厂制剂车间的NPI项目。 Fully engaged in the New Product Transfer (NPI) project from CMC Lab/pilot line to site production line. 3. 参与成熟产品的跨工厂/车间的转移项目。 Attend Product Transfer project between sites and workshops. 4. 参与新产品的商业化上市项目。 Attend the new product commercial launch project. 5. 参与技术批、注册批的生产和准备工作，对新产品生产过程中出现的工艺相关问题提供技术解决方案。 Be involved in the preparation and manufacturing of Technical Batch and Registration batch, deliver Technical solution for process related problems for new product. 具体工作内容： 1. 参与处方工艺开发，评估建议的工艺在大生产可能会出现的质量、安全、成本方面的影响，并向CMC 提供洞察以促进工艺优化。 Be involved into the early stage of formulation process development, assess the impact of proposed process to mass production, in terms of quality, EHS, and cost, find out the problems in the production process and provide technical insight to CMC to foster process optimization for future mass production. 2. 在NPI项目中，承担下列职责，确保NPI按时成功完成， 包括但不限于： Taking following responsibility in NPI project to ensure the on time and successful delivery, includes, but not limited to: • 按时完成工厂影响评估，并提出改进建议。 Complete the Site Impact Assessment on time, and put forward improvement. • 独立完成NPI的项目。 Complete NPI projects independently. • 和生产部一起负责NPI所需生产设备/备件的URS, FAT, SAT, 调试和验证。 Responsible for URS, FAT, SAT, commission and qualification of the process equipment& parts for NPI project together with OSD production. • 跟踪NPI原材料到位情况。 Following the material readiness for NPI project. • 设计NPI批次中GMP批次的批记录。 Design Batch Records for the GMP batch of NPI. • 参与技术转移批，安慰剂批和试验批的生产和新技术的实施，并发现生产工艺中存在的问题。 Participate the manufacturing of TT/Placebo/Trail Batch, and new technology implementation, find out the problems in the produciton process. • 与CMC、生产和验证团队紧密合作，在新产品导入中进行设备清洁方法的开发或引入新的清洁技 术。 Working with CMC, OSD production and Validation team, develop the cleaning method and apply the new cleaning technology during NPI. • 负责新产品包装工艺的开发和优化。 Responsible for the development and optimization of new product packaging process. • 与市场和法务、生产、质量团队紧密合作，负责Artwork的设计开发和更新的本地工作。 Working closely with Marketing, RA, Production and Quality team, lead local activities related with Artwork development and update. 3. 在NPI项目中，为操作工提供必要的工艺、操作以及潜在风险的培训。 Provide neccesary process technology,equipment operation and potential risks training to operators during the NPI project. 4. 负责产品获批后的首批商业化生产的部分项目，确保产品按计划上市。 Responsible for the part of project in the first commercial batch, ensure that the products are listed as planned. 5. 负责成熟产品的跨工厂/生产线间转移项目, 确保按时完成。 Responsile the established Product Transfer between sites and lines, ensure on time and right first time delivery. 6. 其他领导安排的任务。 Other tasks assigned by the line manager. 大学本科以上学历，制药工程、化学工程、生物化工或相关专业毕业。 Bachelor or above education in Pharmaceutical Engineering, Chemical Engineering, Biochemical Engineering or related subjects 工作经验： 1. 至少5年以上药品生产企业经验。 Minimum 5 years experience in pharmaceutical manufacturing environment. 2. 具有在跨国大型药企的工作经验 MNC big pharma working experience. 3. 具有工艺开发、工艺放大、技术转移、产品转移的经验。 Experience in Process development, scale up, Technical Transfer and Product Transfer. 4. 参与过新产品引入或者技术转移项目。 Experience in NPI and/or Technical transfer project. 5. 不同剂型药品生产经验，至少有固体制剂经验。 Experience in different dosage form manufacturing, OSD experience is a must. 技术要求： 1. 丰富的GMP知识、基本的EHS知识。 Knowledge and understanding of GMP, basic EHS Knowledge. 2. 了解工艺和物料的变化对产品质量的影响。 Understands the impact of process and material changes on product performance. 3. 制剂制造和包装方面的工艺和设备知识。 Knowledgeable of process and equipment of Drug Product manufacturing & packaging. 4. 产品开发和工艺开发方面的知识，有材料科学方面的知识更好。 Knowledgeable in product and process development, appreciable understanding of materials science. 5. 具有较强的良好人际关系技巧、沟通技巧和影响力。 Highly effective interpersonal, communication and influencing skills. 6. 项目管理能力。 Project Management Skill. 7. 较强的学习能力。 High degree of learning agility. 语言能力/计算机知识： 1. 良好的中英文写作和沟通技巧。 Good written and communication skill in both English and Chinese. 2. 能够熟练使用电脑。 Good Computer skill, eg. 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