武汉招聘

  

Principal Duties and Responsibilities

• 参加成品药生产部门的日常活动。

Participate the daily activities of the Drug Product Manufacturing Group.

• 编制成品药生产流程文件。

Author documents for drug product manufacturing processes.  

• 按要求参加内部审核程序。

Participate in the internal auditing program as required.

• 为QA提供有关GMP设施问题的意见，并对环境监测和验证计划进行监督。

Provide input to QA on GMP facility issues and maintain oversight of the Environmental Monitoring and Validation programs.

• 预测潜在问题并采取预防措施，并根据需要升级流程问题以确保解决问题。

Anticipate potential problems and take preventative actions and escalate process issues as necessary to ensure resolution.

• 审核文档并检查所有计算（例如批记录、标签设备读数）。

Review documentation and check all calculations (eg batch records, labels equipment readings).

• 确保操作严格遵守所有QA控制文件（例如SOP、批记录）和cGMP/质量要求。

Ensure operations strictly adhere to all QA-Controlled documents (such as SOPs, Batch Records) and cGMP/Quality requirements.

• 必要时升级流程问题以确保解决问题。

Escalate process issues as necessary to ensure resolution.

• 确保GMP培训要求完整且最新。

Ensure GMP training requirements are complete and current.

• 确保所有工作都以安全的方式执行，并符合各项服务需求规范。

Ensure all work is performed in a safe manner and meets the specifications for each service request.

• 在工厂的所有工作中使用适当的PPE（个人防护设备）。

Apply proper PPE (Personal Protective Equipment) to all work in the facility.

• 清洁并维护GMP设施和生产设备。

Clean and maintain the GMP facility and production equipment.

Job Requirements

• 理科学士学位（生物或工程学科，例如生物技术、生物化学、化学/生物化学工程等），3年生物技术行业工作经验。

Bachelor degree with 3 years’ experience in the biotech industry; the degree should be in a biological or engineering discipline (Biotechnology, Biochemistry, Chemical/Biochemical Engineering, or equivalent).

• 具备对无菌生产工艺的技术理解，以及GMP生产、监管原则和要求等工作知识。

Technical understanding with aseptic manufacturing process and working knowledge of GMP manufacturing and regulatory principles and requirements.

• 具备无菌成品药生产经验，具备蛋白质药品生产经验者优先考虑。

Experienced in aseptic drug product manufacturing, preferably protein drug.

• 良好的中英文口头和书面交流能力（阅读、写作、口语）。

Good oral and written communication skills in English and Mandarin (Read, Write, Verbal).

• 能够编写详细的报告和总结，掌握良好的文档处理技术。

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

• 能够在团队中进行有效沟通和专业工作。

Communicate effectively and work professionally in a team environment.

• 熟练使用计算机和自动化驱动设备。

Skilled in the use of computers and automation-drive equipment.

• 必须适应灵活的工作班次（白班、夜班、周末），接受加班。

Must be flexible to work on any shift (day, night, weekend) and able to work prolong duration on your feet.

  

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。