活性及残留分析研究员（应届生）(J19782)

职位描述

主要职责：

1. 基于抗体作用机制（MOA），负责生物分析方法的开发、优化、确认及验证，包括但不限于ELISA、酶活、残留、细胞功能分析方法，并负责相关SOP的撰写、修订与维护；

Responsible for the development, optimization, qualification and validation of bioanalytical methods based on the Mechanism of Action (MOA), including but not limited to ELISA, enzymatic activity, residuals, and cell-based functional assays, as well as the drafting, revision, and maintenance of related SOPs.

2. 负责或支持产品放行、稳定性和申报质量研究等样品的生物活性检测；

Lead or support bioactivity testing for product release, stability studies, and regulatory filings.

3. 负责或支持检测方法的培训、共验证和转移；

Lead or support the training, co-validation, and transfer of the methods.

4. 负责或支持QC生物活性方法样品检测相关偏差、OOS/OOT等问题的调查与分析；

Lead or support the investigation and analysis of deviations, OOS, OOT, and other issues related to sample testing in QC bioactivity assays.

5. 支持完成药物IND、NDA申报过程中生物活性相关的技术研究、数据整理及申报资料和技术报告的撰写；

Support the completion of bioactivity-related technical studies, data collation, and the drafting of regulatory dossiers and technical reports during IND and NDA filings.

6. 参与部门内项目管理相关工作，协助推进项目进度及跨部门协作；

Participating in inter-departmental project management, assisting in driving project progress, and cross-functional collaboration.

7. 按要求完成上级交付的其他相关工作。

Completing other tasks assigned by the supervisors as required.

任职要求

任职要求：

1. 硕士研究生及以上学历；

Master’s degree or above

2. 细胞生物学、药学、免疫学、基础医学、分子生物学、生物技术等相关生物医学专业背景；

Background in Cell Biology, Pharmacy, Immunology, Basic Medicine, Molecular Biology, Biotechnology, or related biomedical disciplines

3. 了解单克隆抗体相关理论知识，了解其结构特点与生物学功能，具备较强的学习能力以及文献检索、阅读和总结能力；

Sound understanding of monoclonal antibody (mAb) theories, structural characteristics, and biological functions, with strong learning ability and skills in literature search, reading, and summary

4. 掌握细胞培养及生化免疫分析相关基础理论与实验技能，具备扎实的实际操作经验和较强的动手能力；具有ELISA、Cell based Assay、细胞增殖/抑制、凋亡、吞噬、ADCC、CDC、酶活性分析及流式细胞仪等实验经验者优先；

Proficient in basic theories and hands-on laboratory skills related to cell culture and biochemical/immunoassays, with solid practical experience; hands-on experience in ELISA, Cell-based Assays, cell proliferation/inhibition, apoptosis, phagocytosis, ADCC, CDC, enzymatic activity assays, and flow cytometry (FACS) is preferred.

5. 具备良好的实验规范意识，能够及时、规范完成实验记录与实验报告，并对实验数据进行分析、总结及问题定位与解决；

Strong awareness of good laboratory practice, able to complete experimental records and reports in a timely and compliant manner, and capable of data analysis, synthesis, troubleshooting, and problem-solving

6. 具备良好的沟通能力和团队协作意识，能够高效开展跨团队合作；

Excellent communication and teamwork skills, with the ability to collaborate effectively across functional teams

7. 工作积极主动，责任心强，能够在多任务环境下承担并推进多项工作

Proactive mindset and strong sense of responsibility, with the ability to multi-task and drive multiple deliverables in a fast-paced environment.