QC 理化分析高级研究员

1. 01

   蛋白纯度检测 Protein Purity Testing 负责蛋白药物纯度及相关质量属性检测。 独立执行并审核相关分析实验，包括但不限于： CE-SDS SEC-HPLC CIEF / icIEF HPLC/UHPLC 负责实验数据分析、结果审核及趋势分析。 Perform protein purity and related quality attribute testing for biologics. Independently conduct and review analytical testing including but not limited to: CE-SDS SEC-HPLC CIEF / icIEF HPLC/UHPLC Conduct data analysis, result review, and trend evaluation.

2. 02

   实验室调查与偏差管理 Laboratory Investigation & Deviation Management 独立开展实验室调查（Laboratory Investigation）和偏差调查（Deviation Investigation）。 运用科学原理分析异常数据、OOS、OOT及其他质量事件。 识别根本原因（Root Cause），制定并推动CAPA落实。 撰写高质量调查报告并支持内部及外部审计。 Independently perform laboratory investigations and deviation investigations. Evaluate atypical data, OOS/OOT results, and other quality events using scientific approaches. Identify root causes and drive effective CAPA implementation. Author investigation reports and support internal and external audits.

3. 03

   技术支持与问题解决 Technical Support & Problem Solving 对检测过程中出现的技术问题进行分析和解决。 支持分析方法优化、方法确认、方法验证及方法转移工作。 Investigate and resolve technical issues encountered during testing. Support method optimization,

, validation, and transfer activities. 4. 合规与质量 Compliance & Quality 严格遵守GMP、数据完整性及实验室管理要求。 确保实验记录和数据的完整性、准确性和可追溯性。 Ensure compliance with GMP, data integrity, and laboratory procedures. Maintain accurate, complete, and traceable documentation. 任职要求 Qualifications: 教育背景 Education 生物化学、分析化学、生物学、分子生物学、生物工程等相关专业硕士及以上学历。 Master's degree or above in Biochemistry, Analytical Chemistry, Biology, Molecular Biology, Bioengineering, or related disciplines. 工作经验 Experience 硕士需5年以上专业领域经验，博士无专业领域经验要求。 Master's degree with a minimum of 5 years of relevant industry experience required. Candidates with a Ph.D. are exempt from the experience requirement. 专业能力 Technical Competencies 具备扎实的蛋白纯度分析理论知识及实践经验。 熟悉CE-SDS、SEC-HPLC、CIEF/icIEF等蛋白纯度分析技术。 具有较强的数据分析能力和科学问题解决能力。 能够独立完成实验室调查、偏差调查和根因分析。 Strong technical knowledge and hands-on experience in protein purity analysis. Familiar with CE-SDS, SEC-HPLC, CIEF/icIEF, and related analytical techniques. Excellent analytical thinking and problem-solving skills. Capable of independently conducting investigations and root cause analyses. 语言要求 Language Skills 具备良好的英语听、说、读、写能力。 能够独立阅读英文法规、技术文件及与国际客户进行沟通。 Good command of English in listening, speaking, reading, and writing. Able to read technical/regulatory documents and communicate effectively with global clients.