武汉招聘

Principal Duties and Responsibilities

• Oversees and executes manufacturing process to ensure safety, aseptic operations and compliance with cGMPs.

• Oversees and executes all routine and critical operations as well as commissioning and validation activities.

• Coordinate the workflow (ensuring availability of materials and supplies for production) and documentation to maintain the productivity of the unit.

• Support regulatory and audit inspections and serves as an SME to answer specific questions.

• Support the start-up of the department (recruitment, retention, training and personal development, resource assessment, performance management etc.) to build a high performing production team.

• Ensure adequate allocation of human and technical resources to achieve objectives.

• Monitor material consumption and coordinate all materials deliveries.

• Facilitate technology transfer within the unit.

• Primary contact for troubleshooting and issue resolution or escalation.

• Help establish the department’s annual budgets (FTE’s, costs, maintenance, investments etc.).

• Ensure compliance with safety, cleanliness and storage (housekeeping, 5S).

• Initiate deviations or investigations of various complexities and work with cross-functional departments to identify root cause.

• Complete action items for cGMP investigations and CAPA’s.

• Revise and author Standard Operating Procedures/Batch Records.

• Communicate any quality issues/concerns to QA.

   

  Job Requirements

• Degree (Master or higher) in Life Sciences/ Engineering or related discipline

• Minimum 5 years of experience in the biotechnology industry, including at least two year of experience in managerial role.

• Experience in cell culture development & Start-up experience preferred

• Excellent oral and written communication skills in English and Mandarin (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving investigations and theory and ability to write technical documents.
  

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。