武汉招聘

Job  Responsibilities    

• Perform physical-chemical  analysis of in-process sample, drug substance, drug product and stability  sample according to SOPs.

      标准操作规程执行中间控制样品，原液，成品以及稳定性样品的理化分析检测；

• Participate in method  transfer, verification and method validation activities which include protocol  drafting, execution, data analysis and completing the summary report.

      方法转移，确认以及验证的相关活动，包括方案起草，执行，数据分析以及总结报告；

• Create and implement all  necessary SOPs.

      必要的标准操作规程的文件；

• Provide daily operation  support in QC laboratory, such as equipment maintenance, 5S management.

       QC实验室的日常操作支持，例如设备维护，5S管理等；

• Understand technical aspects  of the job, best practices, and adhere to cGMP compliance.

       工作相关的技术，良好的操作技能，并遵守cGMP合规性；

• Other work arranged by  superior leaders.

       领导安排的其他工作。 

Job  Requirements

• Master in a  related scientific discipline (Chemistry, analytical-chemistry or equivalent  scientific experience if all other criteria are met) with 1+ years’ experience  or Bachelor in a related scientific discipline, with 3+ years’ experience.

       研究生化学、分析化学或相关专业并有1年及以上相关工作经验；本科化学、分析化学或相关专业并有3年及以上相关工作经          验；

• Extensive  experiences in analytical testing for protein analysis, such as HPLC, CE, MS,  iCE3, UV, etc;

       蛋白质分析测试方面工作经验，如高效液相色谱、毛细管电泳、质谱、ICE3、紫外扫描等；

• Extensive  experience in method development, qualification, validation and method transfer  of physical-chemical methods;

       在理化分析方法的方法开发、确认、验证和方法转移方面有丰富经验；

• In-depth knowledge  of scientific, analytical, manufacturing and regulatory principles;

       技术，分析，生产以及法规都有比较深入的了解；

• Work in GMP  environment, and experienced in GMP documentation, testing and investigations;

       在GMP环境中工作，有GMP文件、记录，检测和调查等相关经验；

• Good English  listening, speaking, reading and writing skills.

       良好的英文听说读写能力。

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。