细胞生物学部研究员-Biosafety-上海临港

担任细胞生物学研究员，负责开展细胞培养、细胞生物学分析及病毒安全性相关检测工作，为生物制品研发、生产及质量评价提供可靠的技术支持和数据保障；

严格遵循GLP、cGMP、NMPA及其他适用国际法规、行业指南和标准操作程序（SOP）要求开展实验活动，确保实验过程及结果符合质量与合规要求；

参与客户项目实施、技术支持及业务持续改进工作，推动检测任务高质量交付和实验平台高效运行；

负责实验平台及相关实验资源的建立、维护与管理，为项目顺利实施提供技术保障 · 完成公司及部门安排的其他相关工作; 主要职责： · 严格遵循GLP、cGMP及公司质量体系要求开展实验活动，依据FDA Points to Consider（PTC）、ICH Q5A（R2）、USP 、《中国药典》等适用法规和行业指南实施细胞培养、细胞生物学分析及病毒安全性相关检测工作，确保实验过程、结果报告及数据管理符合监管要求和数据完整性原则 · 独立承担项目实验执行工作，根据项目需求完成检测方案实施、结果评价及技术文件输出，确保项目按计划完成交付 · 与项目管理、质量保证及相关职能团队保持高效协作，共同推动项目顺利实施，确保项目按质量和进度要求完成交付并满足客户需求；

参与实验方法优化、技术改进及效率提升工作，持续提升检测质量、实验效率和资源利用水平 · 及时识别实验过程中的异常、偏差及潜在风险，开展调查分析、影响评估及根因分析，制定并推动纠正预防措施实施，确保问题得到有效解决并持续降低质量风险 · 及时向项目负责人及部门主管同步实验进度、异常情况与工作成果;

持续关注专业领域法规要求、技术发展趋势及行业最佳实践，不断提升专业技术水平和业务能力。

生物学、细胞生物学、生物技术、生物工程、药学或相关专业硕士及以上学历；

熟悉细胞培养、无菌操作及细胞生物学相关实验技术，具备独立开展实验的能力；

具备细胞培养、细胞生长特性评价及病毒检测相关实验经验，熟悉共培养检测、逆转录病毒检测等技术者优先 · 具备良好的实验设计、数据分析及问题解决能力，能够独立分析实验结果并解决实验过程中出现的技术问题；

具备良好的英语读写能力，能够熟练阅读英文法规、技术文件及进行日常书面沟通；

具备良好的沟通协调能力和跨团队协作意识，能够与项目团队及相关职能部门保持有效合作；

工作严谨细致，具有较强的责任心、执行力、学习能力及结果导向意识。 Biosafety Testing Cell Biology Scientist Job Description Position Summary： · Serve as a Cell Biology Scientist, responsible for cell culture, cell biology analyses, and virus safety-related testing activities, providing reliable technical support and data to support the development, manufacturing, and quality assessment of biopharmaceutical products. · Conduct laboratory activities in strict compliance with GLP, cGMP, NMPA regulations, applicable international regulatory requirements, industry guidelines, and Standard Operating Procedures (SOPs), ensuring quality, compliance, and data integrity throughout experimental processes. · Support client projects, technical activities, and continuous business improvement initiatives, contributing to high-quality project delivery and efficient laboratory operations. · Responsible for the establishment, maintenance, and management of laboratory platforms and related experimental resources, providing technical support for successful project execution. · Perform other duties and responsibilities as assigned by the company and department.. Key Responsibilities: ·Conduct laboratory activities in accordance with GLP, cGMP, and company quality systems, and perform cell culture, cell biology analyses, and virus safety-related testing in compliance with applicable regulations and guidelines, including FDA Points to Consider (PTC), ICH Q5A(R2), USP , and the Chinese Pharmacopoeia, ensuring regulatory compliance, data integrity, and accurate reporting. ·Independently execute project-related experiments, including study implementation, result evaluation, and technical documentation preparation, ensuring projects are completed on schedule and meet quality requirements. · Collaborate effectively with Project Management, Quality Assurance, and other cross-functional teams to support successful project execution and ensure timely delivery that meets client expectations. · Participate in method optimization, technical improvements, and efficiency enhancement initiatives to continuously improve assay quality, laboratory productivity, and resource utilization. · Identify experimental deviations, anomalies, and potential risks in a timely manner; perform investigations, impact assessments, and root cause analyses; and drive the implementation of corrective and preventive actions (CAPAs) to effectively resolve issues and reduce quality risks. ·Regularly communicate project progress, experimental results, and any issues or risks to project leads and department management. ·Remain current with regulatory requirements, technological advancements, and industry best practices within the relevant scientific fields, continuously strengthening professional expertise and technical capabilities. Minimum Requirements ·Master's degree or above in Biology, Cell Biology, Biotechnology, Bioengineering, Pharmacy, or a related discipline. ·Solid knowledge of cell culture, aseptic techniques, and cell biology laboratory practices, with the ability to independently perform experimental work. ·Hands-on experience in cell culture, cell growth characterization, and virus-related testing; experience with co-cultivation assays, retrovirus detection assays, or related techniques is preferred; ·Strong experimental design, data analysis, and problem-solving skills, with the ability to independently interpret results and resolve technical challenges encountered during laboratory activities; ·Good English reading and writing skills, with the ability to understand regulatory guidelines, technical documents, and conduct routine written communication in English. ·Strong communication and interpersonal skills, with the ability to collaborate effectively with project teams and cross-functional stakeholders. ·Detail-oriented and highly responsible, with strong execution, learning agility, and a results-driven mindset.