Full Time

Senior DS Manager

Posted 2 months ago
Application deadline closed.

Job Description

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description

Job Purpose 工作目的

  • Assist in the completion of the validation activities in the Phase 2 DS production line in Guangzhou factory.

协助完成Phase 2广州工厂期 DS 生产线的验证活动。

  • Assist to establish Phase 3 DS production line in Guangzhou factory. Optimize bio-product procedure, secure operation GMP compliance.

协助在建立Phase 3广州 工厂期DS生产线。 优化生物产品程序,安全运行GMP合规。

Main Responsibilities主要职责:

  • Construction of production and technical teams, as well as design and construction of workshops;

生产、技术团队的组建,生产车间设计与建设;

  • To establish and improve DS quality assurance management system, establish and implement production file system as well as organizing and supervising the operation of production quality system;

建立并完善生产质量保证管理制度,做好生产文件体系的制定与实施,组织实施并监督生产质量体系的运行;

  • To ensure the progress and quality of DS production, compliance with GMP regulations and successful FDA inspection;

保证项目原液生产的进度和质量,确保符合GMP相关法规并通过FDA现场检查;

  • To be responsible for the training, instruction and management of production teams in DS workshop, coordinate effective communication and cooperation among units relating to production and to ensure the successful completion of production;

负责原液车间生产团队的培训、指挥与管理,协调各个生产相关部门的沟通与合作,保证生产的顺利完成;

  • Effective management of product quality and cost control to ensure compliance with expected objectives and requirements

有效的管理产品质量与成本控制,达到公司预期的目标要求;

  • Any other assignment as is determined by supervisor.

完成上级安排的其他工作。

Qualification Required

Job Requirement 职位要求

  • Master or above degree in Pharmacy, Biology, Chemistry, etc . 硕士或以上学历,药学,生物学或化学专业 .
  • At least 10 years manufacturing experiences of manufacturing products and at least 7 years manufacturing supervisory/managerial roles .

医药行业 10 年以上生物制药生产经验, 7 年以上生产主管经验。

  • Familiar with manufacturing of biological products, familiar with GMP/GLP requirements, with experience in building workshops consistent with FDA requirement.

熟悉生物制药产品生产,熟悉 GMP/GLP 相关要求,有筹建 GMP 车间的经验和经 历。

  • Proactive and dedicated with a strong sense of responsibility and integrity;

积极敬业、主动进取、责任心强、正直向上;

  • Competent in organization and coordination, team leadership, analytical skills and problem solving;

有较强的组织协调能力、良好的团队领导力、较强的分析和解决问题的能力;

  • Good at oral and written English and computer skill.

口 头 和 书 面 英语水平良好,会熟练使用电脑 。

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