武汉招聘

Job Responsibilities

1. Direct cell-based assay development activities and work closely with quality control (QC) team for analytical method transfer, qualification, and validation;

   带领细胞试验的方法学开发工作, 并与QC部门合作进行分析方法移转、确认与验证；

2. Lead analysis team members to conduct bioassays, including ELISA binding and cell-based assays;

   带领分析团队成员进行活性分析，包括ELISA和细胞试验等；

3. Perform routine analysis of MSAT as well as GMP samples, including in-process according to SOPs;

   根据SOP带领团队执行MSAT 和GMP 样品的常规分析，包括中控样品等；

4. Participate in the method development and validation of protein drug analytical method; implement the preparation of SOP and method validation reports;

   参与蛋白药物检测方法开发及验证; 执行SOP与方法学验证报告的撰写；

5. Responsible for managing technical documents including operating procedures, drafts, reports, risk assessments, laboratory investigations, etc.;

   负责管理技术文件包括操作规程，草案，报告，风险评估，实验室调查报告等；

6. Present to cross functional teams and effectively communicate critical analytical issues and solutions;

   针对关键问题与跨模块团队合作, 有效沟通, 并提出解决方案；

7. Communicate effectively with the company’s internal and external departments to successfully complete the project on time;

   与公司内外各部门进行有效沟通，顺利推动项目按时完成；

8. Other work arranged by superior leaders.

   上级领导安排的其他工作。

Job Requirements

1. Master degree or above, major in cell biology and molecular biology, PhD with 5 years or more and MS with 8 years or more of biochemical bioassay work experience, and experience in completing projects independently; have QC experience is a plus;

   硕士及以上学历，生物化学、分子生物学相关专业，博士具有5年及以上/硕士具有8年及以上工作经验，有独立完成项目的经验；具备QC经验尤佳;

2. Have practical operation experience in instrument analysis, familiar with various analysis techniques (e.g. potency assay, ADCC, CDC, neutralization assay, FACS, ELISA and ECL), and master various biochemical test methods, confirmation, verification and transfer processes;

   具有仪器分析的实际操作经验，熟悉各种分析技术(效价分析、ADCC、CDC、中和试验、FACS, ELISA和ECL)，对上下游工作流程熟悉，并熟练掌握各种生化测试方法、确认、验证和转移过程；

3. Understand ICH, USP, ChP regulations and guidelines;

   了解ICH, USP, ChP法规和指导原则；

4. Excellent oral and written communication skills in English.

   良好的英文读写和沟通能力。

鼎康生物是一家领先的CDMO公司，可提供一站式的CMC解决方案，支持从早期药物开发到后期临床研究和商业化cGMP生产。鼎康引进了全球***模块化生物制药工厂Kubio；为客户开发的多个产品已经在全球20多个国家进行临床试验。在不久的将来，鼎康生物总产能将超过140,000L。我们承诺通过技术和生产创新，使全球患者都能负担得起具有国际标准的生物药物，提高治疗水平以改善人类健康。