武汉招聘

Job Responsibilities

• Responsible for process improvement of project products, including but not limited to process recipes, analytical performance evaluation, stability studies, etc,;

  负责项目产品的工艺改进，包括但不限于工艺配方、分析性能评估、稳定性研究等；

• Lead analysis team members to conduct biochemical analysis, including Residual HCP, hcDNA, ProteinA testing, etc.;

带领分析团队成员进行生化分析，包括残留HCP,hcDNA,Protein A 等；

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

根据SOP执行MSAT 和GMP 样品的常规分析，包括中控样品等；

• 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

• 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；

• Review IND, BLA and other regulatory documents.

审核IND,BLA和其他法规文件；

• 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；

• Other work arranged by superior leaders.

  上级领导安排的其他工作。

Job Requirements

• Master degree or above, major in cell biology and molecular biology, with 6 years or more of biochemical analysis 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，具有6年及以上生化分析工作经验，有独立完成项目的经验；具备QC经验尤佳

• Have practical operation experience in instrument analysis, familiar with various analysis techniques, familiar with upstream and downstream work processes, 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，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；

• Understand ICH, USP, ChP regulations and guidelines.

了解ICH, USP, ChP法规和指导原则；

• 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。