武汉招聘

  

Job Responsibilities/岗位职责

  

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

   按照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；

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

   参与方法转移，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；

3. Create and implement all necessary SOPs.

   起草必要的标准操作规程的文件；

4. Satisfy cGMP compliance and handle quality event such as OOS, Deviation, CAPA and Investigation, independently.

   遵守cGMP合规性并能独立处理相关质量事件如超标，偏差，纠正与预防措施及调查等；

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

   提供QC实验室的日常操作支持，例如设备维护，5S管理等；

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

   了解工作相关的技术，良好的操作技能，并遵守cGMP合规性；

7. Other work arranged by superior leaders.

   上级领导安排的其他工作。 

                            

 

  

Job Requirements/岗位要求

  

1. Master in a related scientific discipline (Chemistry, analytical-chemistry, biology or equivalent scientific experience if all other criteria are met) with 3+ years’ experience or Bachelor in a related scientific discipline, with 5+ years’ experience.

   硕士研究生化学、分析化学、生物学或相关专业并有三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五年及以上相关工作经验；

2. Extensive experiences in analytical testing for protein and antibody analysis, such as HPLC, CE, MS, iCE3, UV, etc;

   具有蛋白质或抗体分析检测工作经验，如高效液相色谱、毛细管电泳、质谱、ICE3、紫外扫描等；

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

   具有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；

4. In-depth knowledge of scientific, analytical, manufacturing and regulatory such as principles;

   对于技术，分析，生产以及法规都有较深入的了解；

5. Work in GMP environment, and experienced in GMP documentation, testing and investigations;

   曾经在GMP环境中工作，有GMP文件、记录，检测和调查等相关经验；

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

   良好的英文听说读写能力。

7. Team building experience is appreciated.

   有团队建立经验可优先考虑。

                            

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。