锦鲤求职岗位描述
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.