QC 理化分析高级研究员

职位概述 Job Summary:

负责生物制品质量控制实验室中蛋白纯度相关检测项目的执行、方法问题排查以及实验室调查工作，确保检测工作符合GMP要求。作为SME，需具备扎实的蛋白纯度分析专业知识、较强的问题分析与解决能力，并能够独立开展实验室调查（Laboratory Investigation）和偏差调查（Deviation Investigation）。

Responsible for execution of protein purity-related analytical testing, troubleshooting analytical issues, and leading laboratory investigations within the Quality Control laboratory. The incumbent is expected to possess strong expertise in protein purity analysis, excellent problem-solving capability, and the ability to independently conduct laboratory and deviation investigations.

主要工作职责 Key Responsibilities:

1. 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. 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. 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, qualification, 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.