武汉招聘

  

  

Job Responsibilities/岗位职责

  

• Lead, develop and maintain a robust and stable microbiology and environmental monitoring team, with high productivity. 

  

管理，发展和维护一个高效率、稳定、强健的微生物和环境监测团队

  

• Responsible for GMP compliance of the team.  Ensure all the testing are completed in a timely manner according to relevant SOP and GMP standard.

  

负责团队的合规性，确保所有的检测都按照相关SOP和GMP标准按时执行;

  

• Manage microbial testing activities in raw materials, intermediate, DS and DP. 

  

带领团队进行原辅料，中间品，原液和制剂的微生物检测。

  

• Design and oversee microbiological validations as needed for various samples

  

指导各类样品微生物检测的验证工作

  

• Develop and implement Standard Operating Procedures for new processes and methods.

  开发落实新的流程和方法

    

• Implement and manage the EM programs for controlled areas.

  

制定和实施环境监测计划

  

• Contribution to validation, qualification/requalification of the clean utilities/facilities

  

对洁净区的验证提供建议和审核

  

• Act as Site Subject Matter Expert for Microbiology and Aseptic Control

  担当微生物和无菌控制的SME

    

• Closely monitor the environmental monitoring contamination control status, proactively identify and solve any problem or risk.

  

密切关注环境监测污染控制状态，主动提前识别并解决任何问题或风险。

  

• Lead all the OOS investigation, deviation investigation, close CAPA, change control in a timely manner.

  

主导OOS调查、偏差调查，及时关闭CAPA和变更控制;

  

• Host internal or outside audit.

  

接待内部或外部审计;

  

• Continuously improve lab operation compliance, efficiency, reduce cost.

  

持续改善实验室运营符合性、效率和降低成本;

  

• Any other tasks as assigned by the director.

  

总监安排的其他任务。

    

Job Requirements/岗位要求

  

• Bachelor degree in chemistry, biology, microbiology or pharmaceutics discipline with 10+ years’ experience in pharmaceutical company quality control department, or Master’s degree with 8+ years’ experience.

化学、生物学或药学本科10年以上经验，或硕士8年以上经验;

  

• Expertise with USP, EP, ChP requirement on environmental monitoring.

  

熟悉USP, EP和ChP对于环境监测法规要求;

  

• Well versed in microbiology based testing, with abundant hands-on experience.

  

精通微生物检测，有丰富一线操作经验;

  

• Aseptic and sterile manufacturing experience strongly preferred. 

  

有无菌工艺生产经验的会优先考虑

  

• Thorough knowledge of NMPA, EMA and US FDA GMP practices and regulations.

  

熟知NMPA，EMA和US FDA GMP法规;

  

• Communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups

  

具备和各个层面及部门沟通协调能力

  

• Ability to train, develop and mentor direct reports and effectively manage the performance of individuals.
  有管理，发展，指导团队成员的经验
• Excellent oral and written communication skills in English.

  

优秀的英文说写沟通能力。

  

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。