高级/副高级研究员-分析细胞株构建

Functional cell line development

Senior Scientist / Principal Scientist

We are seeking a highly motivated scientist to lead cell line engineering and cell-based assay development activities supporting the characterization, potency assessment, and regulatory advancement of innovative biologic therapeutics.

Responsibilities:

1. Develop and engineer functional stable cell lines using viral (e.g., lentiviral transduction) and non-viral technologies (e.g., CRISPR/Cas9 genome editing) to support therapeutic biologics development, and characterization.

2. Design, optimize, and execute cell line development workflows, including high-throughput screening, single-cell cloning, cell isolation, and functional validation to establish robust target-expressing cell lines.

3. Lead and mentor junior scientists, providing technical guidance and fostering collaboration across multidisciplinary teams to achieve project milestones and organizational objectives.

4. Develop, optimize, qualify, and transfer cell-based functional assays for the assessment of mechanism of action (MOA), biological activity/potency, and critical quality attributes (CQAs) to support process development, comparability studies, product characterization, and lot release testing.

5. Collaborate closely with cross-functional teams, including Discovery, Process Development, Analytical Development, Manufacturing, Quality, and Regulatory Affairs, to advance biologics programs from early development through commercialization.

6. Provide technical leadership in assay troubleshooting, data interpretation, and scientific innovation, ensuring the development of robust and regulatory-compliant methodologies.

7. Support global regulatory submissions and agency interactions, including preparation of technical documentation and responses to regulatory inquiries from health authorities such as the U.S. FDA, China NMPA, EMA, and other international agencies.

8. Stay current with scientific and technological advancements in cell engineering, gene editing, immunology, and cell-based bioassays, and drive the implementation of innovative technologies and best practices.

Basic qualifications:

1. PhD or MS in Biochemistry/Biotechnology, Cell Biology, Immunology, or related field.

2. 0-2 years for PhD or 3-5 years for MS of industrial experience in cell line development

3. Strong technical innovation and trouble shooting skills in cell biology, molecular biology and biochemical research.

4. In-depth knowledge of molecular biological techniques, cell signaling transduction, and /or immne regulation knowledge

5. Excellent spoken and written communication skills in English

功能细胞株开发

副高级研究员/高级研究员

负责生物药分析细胞株构建及细胞活性方法开发，为创新抗体、双抗、融合蛋白等生物药项目提供技术支撑。

岗位职责

利用慢病毒转导、CRISPR-Cas9 基因编辑等技术构建和开发稳定功能性细胞系，为生物药研发及功能学评价提供关键工具。

建立并优化细胞系筛选及鉴定流程，通过高通量筛选、单克隆分离和功能验证获得高质量目标表达细胞株。

领导或指导初级研究人员开展实验工作，促进跨部门合作，推动项目高效执行。

开发、优化和验证细胞功能分析方法（CBA），用于药物作用机制（MOA）、生物学活性（Potency）及关键质量属性（CQA）的评估，支持工艺开发、质量研究及产品放行。

参与国内外生物制品注册申报工作，为 FDA、NMPA 等监管机构审评提供技术支持和答复。

任职要求

生物学、细胞生物学、免疫学、生物技术等相关专业硕士或博士学历。

博士毕业后 0–2 年或硕士毕业后 3–5 年生物制药行业相关工作经验。

具有扎实的细胞生物学、分子生物学及免疫学理论基础和实验技能。

熟悉细胞系构建、基因编辑、细胞信号通路及免疫调控相关研究技术。

具备良好的创新意识、问题解决能力和团队合作精神。

具备优秀的中英文沟通能力，能够独立撰写技术报告并参与监管沟通。