Job Description

主要职责：

一、分析方法开发与验证Analytical Method Development & Validation

1. 根据CMC策略，开发适用于工艺开发、原液及制剂质量控制的特异性分析方法，包括但不限于理化性质分析、结构表征、纯度与杂质检测、活性及稳定性评估等。Develop and validate specific analytical methods (e.g., physicochemical analysis, structural characterization, purity/impurity testing, potency/stability evaluation) per CMC strategy, supporting drug substance/drug product quality control during process development.
2. 参与工艺优化和验证过程中的分析工作，确保分析方法的适用性和可靠性，为工艺变更提供科学依据。Conduct analytical activities for process optimization and validation, ensuring method suitability and reliability, and providing scientific justification for process changes.
3. 设计并执行药物的稳定性研究计划，评估药物在不同条件下的长期稳定性，为药品的有效期设定提供依据。Design and execute drug stability studies to evaluate long-term stability under various conditions, supporting shelf-life determination.

二、合规与数据管理Compliance & Data Management

1. 确保所有分析活动符合国内外CMC相关法规要求，如ICH Q系列指南、FDA和EMA的CMC指导原则等。Ensure all analytical activities comply with domestic and international CMC regulations (e.g., ICH Q-series guidelines, FDA/EMA CMC guidance).
2. 负责实验数据的收集、整理、分析和报告编写，确保数据的准确性和可追溯性。Manage experimental data collection, organization, analysis, and reporting, ensuring data accuracy and traceability.

三、平台建设与管理

1. 关注行业动态，探索并引入新的分析技术和工具，提高分析效率和准确性；参与分析方法的持续优化和改进。Explore and implement novel analytical technologies to improve efficiency and accuracy; continuously optimize existing methods.
2. 与CMC团队其他成员紧密合作，共同解决项目中的技术难题；参与内部培训和技术交流，分享研究成果和实验经验。Collaborate with CMC teams to resolve technical challenges; participate in internal training and knowledge sharing.

任职资格：

教育背景：

硕士及以上学历，生物化学、分子生物学、药学、分析化学或相关专业Master’s degree or above in Biochemistry, Molecular Biology, Pharmacy, Analytical Chemistry, or related disciplines.

相关经验：

课题方向涉及分析检测，熟悉相关仪器操作。Research projects involving analytical testing, with familiarity with relevant instrument operations.

语言要求：

• 具备良好的英语听说读写能力，能够流畅阅读英文专业文献，与国际同行进行技术交流。Strong English proficiency (listening, speaking, reading, writing), capable of fluently interpreting English technical literature and conducting technical communication with international peers.

预期工作地点：

上海/苏州/广州/连云港Shanghai / Suzhou / Guangzhou / Lianyungang

能力要求：

专业技能：

1.实验技能：掌握一定生物药分析技术，包括HPLC、质谱分析、生物活性测试等，能够独立设计并执行实验方案。 Experimental Techniques : Proficient in biologics analytical techniques (e.g., HPLC , mass spectrometry , bioactivity assays ), capable of independently designing and executing experimental protocols.

2.具备一定数据分析能力和，能够熟练运用数据分析软件进行数据处理和解读。 Data Analysis : Basic data analysis capabilities, proficient in using software for data processing and interpretation.

通用能力：

1. 学习能力强，对生物制药工艺开发有浓厚兴趣；Strong learning agility and deep interest in biopharmaceutical process development.
2. 具备系统性思维和数据分析能力，能适应高强度的研发节奏；Systematic thinking and data analysis skills, adaptable to fast-paced R&D environments.
3. 具备独立解决问题能力及良好的跨部门协作意识。Independent problem-solving skills and cross-departmental collaboration mindset.

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