岗位概述 Summary 负责一次包装材料相容性研究相关工作，包括研究方案的设计、分析方法的开发和验证、样品检测，以及可提取物与浸出物（Extractables & Leachables，E&L）平台建设相关的其他工作。 This position is primarily responsible for primary packaging material E&L studies, including study design, method development and validation, sample testing, and other activities related to the building of the Extractables and Leachables (E&L) platform. 岗位职责 Job Responsibilities 具体职责包括但不限于以下内容： The detailed responsibilities include but are not limited to the following: -            根据项目特点设计E&L研究方案，并解决项目执行过程中遇到的相关问题。 Design E&L study protocols based on project requirements and resolve issues encountered during project execution. -            负责E&L研究分析方法的开发与验证，包括验证方案、验证实验、验证报告以及分析方法相关SOP的制定。 Responsible for the development and validation of analytical methods for E&L studies, including validation protocols, validation experiments, validation reports and SOPs for analytical methods. -            按照研究方案执行实验，包括提取实验、样品检测、数据分析等工作。 Executing experiments according to the study protocol, including extraction experiments, sample testing, data analysis, etc. -            及时与客户进行技术沟通和项目汇报，确保研究报告按时、准确交付。 Communicate with clients in a timely manner regarding technical matters and project updates, and ensure the timely and accurate delivery of study reports. -            担任分析仪器领域专家（SME），了解仪器原理，熟练掌握仪器操作与维护，根据需要编写SOP并开展新员工培训。 Act as the subject matter expert (SME) for analytical instruments, understand instrument principles, oversee instrument operation and maintenance, prepare SOPs, and train new employees as needed. -            标准品、试剂耗材等物资的采购与管理。 Procurement and management of standards, materials and consumables. -            推动新技术应用及支持业务推广工作。 Promote new technologies and support business development activities. -            遵守公司质量管理体系、环境健康安全（EHS）及合规性要求。 Complying with Quality System, EHS and Compliance Requirements. 任职资格 Qualification 教育背景 Education -           硕士及以上学历，药学、分析化学、高分子材料等相关专业优先。 M.S. degree or above in a relevant scientific discipline, preferably in pharmaceutical sciences, analytical chemistry, polymer science, or related fields. 工作经验 Experience -           具有至少2年分析测试相关工作经验，具备GC-MS、LC-MS、ICP-OES/MS等分析仪器的实际操作经验。 Minimum of 2 years of analytical laboratory experience, with hands-on experience in GC-MS, LC-MS, ICP-OES/MS, or related analytical techniques. -            具有高分辨质谱技术开展化合物鉴定与结构解析经验的优先。 Experience in compound identification and structural elucidation using high-resolution mass spectrometry (HRMS) is preferred. -           具有E&L研究相关经验者优先。 Experience in E&L studies is preferred. 能力要求 Skills -           中文和英语流利，具备优秀的科学写作和演讲汇报能力。 Fluent in both Mandarin Chinese and English, with strong scientific writing and presentation skills. -           具备良好的沟通能力，能够清晰有效地讨论和解决技术问题。 Strong communication skills and the ability to discuss and resolve technical issues clearly and effectively.