武汉招聘

Job Responsibilities/岗位职责

• Participate in the daily activities of the Cell Culture Manufacturing Group. Apply proper PPE (Personal Protective Equipment) to all work in the facility;

      参与细胞培养组的日常生产活动，应用适当的个人防护用品去完成在厂房内的所有工作；

  

• Participate in the evaluation of new technology, new production process and new production technology;

      参与评估新工艺、新生产流程和新生产技术；

• Escalate process issues as necessary to ensure resolution.

      根据需要逐步优化工艺中的问题并保证解决问题。

• Author MFG-CC GMP documents, ensure GMP training requirements are complete and current.

       起草生产部细胞培养组的GMP文件，确保GMP培训要求以及完成和更新；

  

• Familiar with the handle process of quality events such as deviation, CAPA and change control.

       熟悉偏差，CAPA和变更等质量事件的处理流程；

  

• Ensure operations strictly adhere to all SOPs and cGMP/Quality requirements.

       保证严格根据所有的SOPs和cGMP/质量要求来操作；

  

• Ensure all work is performed in safe manner, the operation complies with EHS requirements and meets the specifications for each service request.

      确保安全的方式去执行所有的工作，操作复核EHS要求，并符合各个服务请求的标准；

  

• Production process monitoring ，review documentation and check all calculations (e.g. batch records, labels, equipment reading).

       生产过程的监控，审阅文件，检查所有的计算（例如批记录，标签，设备的读数等）；

  

• Clean and maintain the GMP facility and production equipment, maintenance of environmental and personal hygiene.

      清洁和维护GMP厂房和生产设备,保持环境和个人卫生；

  

• Participate in the internal auditing program for company as required; Serve as department representative on cross-functional teams.

       根据需要参与公司的内部审计计划；能够担任跨职能团队的部门代表。

Job Requirements/岗位要求

• Bachelor’s Degree in Biochemistry, Cell biology, Microbiology，Fermentation engineering，Life Sciences or relevant background; 

      本科及以上学历，生物化学、细胞生物学、微生物、发酵工程、生命科学或者相关专业；

  

• Basic knowledge and understanding of biopharmaceutical technology, especially the process of monoclonal antibodies or recombinant fusion protein drugs;

      对于生物制药技术有一定了解，特别是单克隆抗体或者重组融合蛋白药物的工艺流程；

  

• Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills;

       能够撰写详细的报告和总结，并展示注重细节的文档技能；

  

• Communicate effectively and work professionally in a team environment;

       善于在团队中进行有效的沟通和专业的工作；

  

• Familiarity of computer-based systems.

       熟悉计算机系统；

  

• Must be flexible to work on any shift (day, night, weekend) and able to work prolong durations on your feet;

       必须灵活的参与任何轮班(白班，晚班，周末)，并能够长时间站立工作； 

  

• Oral and written communication skills in Chinese and English (Read, Write, Verbal). 

       良好的中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。