Director, Biologics Manufacturing

Job Description

As the Head of Biologics Manufacturing you will, provide direction and tactical leadership to the Biologics Manufacturing, including upstream, downstream, Formulation and fill finish.
You will oversee, manage, and direct the initiatives and daily activities of the biologics manufacturing operations. You will collaborate with support departments to ensure manufacturing production goals are achieved and performed in compliance with current good manufacturing practices (cGMP) required by US FDA, EMA and CDE. You will review procedures on an on-going basis, seeking ways to improve efficiency, enhance safety and ensure compliance with regulatory agencies. You will ensure all project deadlines and performance standards are established and met. – First time right principle -. You will assist with the planning and development of the department’s budget. You will also support, direct, and coach subordinate employees.


The ideal candidate will have a Master or Ph.D. Degree from an accredited college or university and a minimum of 8 years management level experience in pharmaceutical manufacturing and/or process development, preferably in biologics.

The ideal candidate will also have demonstrated knowledge and be skilled in:

  • Working knowledge of Current Good Manufacturing Practices (cGMP) and other regulatory requirements
  • Technical knowledge of drug substance/product manufacturing processes, equipment procedures and systems
  • Pharmaceutical principals, practices, and their application
  • Principals of mathematical and statistical computations
  • Principals and practices of budget preparation, tracking and administration
  • Implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources
  • Analyzing and trouble-shooting problems, identifying solutions, recommending and implementing methods, procedures and/or techniques for resolution
  • Functioning as a team leader, coach and mentor, and managing, directing, and coordinating the work of staff
  • Directing, supervising, coordinating, delegating and reviewing the work of assigned department personnel
  • Lean manufacturing principals and practices
  • Superb communication skills, both orally and in writing
  • Languages: fluent in English and Chinese
  • Establishing and maintaining cooperative working relationships with individuals contacted in the course of work
  • Management practices and techniques
  • Demonstrated effective leadership.

Location: Qidong, Jiangsu Province, China

More Careers:


职位描述 负责完成常用剂型的创新药、仿制药处方工艺筛选及优化等制剂药学相关研究工作。 评估项目可行性,把握项目难点,制定处方工艺研发方案,执行项目计划书。 掌握项目进程,指导3-5名组内研发技术人员,撰写项目进度及开发报告,完成相关中、英文申报资料。 管理并维护相关仪器设备,保证实验室的正常运行与研发合规性。 与客户进行前瞻性的研发策略交流,根据项目实际进展情况,适时地对项目策略和计划进行必要调整,必要时起草补充协议或撰写审核新方案。 参与BD,对商业化活动提供必要的科学技术支持;参与或主导新客户访问接待或电话会议。...


职位描述: 有丰富,扎实的有机合成经验,熟练掌握有机合成、产物分离与结构鉴定技能; 熟悉现代有机合成技术和药物化学专业知识,能设计多步复杂的有机合成反应;能设计并合成小分子药物; 熟练掌握文献检索手段,熟练阅读(包括英文)文献和书写英文; 熟练掌握各种常见有机化学专业软件/数据库和办公软件的应用; 熟练编写中文和英文工作报告; 负责研发团队合成项目整体管理工作,包括方案选择与制定,沟通实施,进程把控,项目评估等; 负责研发部门技术难点问题的指导处理; 按照公司安全及GMP质量控制规范,负责工艺优化,与相关部门紧密合作完成中试生产。...


职位描述: 负责研发团队的日常管理和业务指导,保障研发团队高效运行。 领导研发团队根据项目要求,制定研发流程和工作计划执行并指导具体研究工作; 负责制定研发团队的目标计划和绩效考核体系,不断提高研发团队效率。 配合 BD 部门负责市场业务推广,保持与客户的紧密沟通。 职位要求: 有机合成、药物化学等相关专业,博士及以上学历; 15年以上知名医药公司或 CRO/CDMO 原料药技术研发和管理经验,深刻理解CDMO业务的特点和要求; 至少5年以上技术研发团队管理经验,具备系统的原料药研发及工艺技术开发相关经验;...


1F & 3F, Block A
2829 JinKe Road
Zhangjiang Hi-Tech Park
PuDong New Area
Shanghai China, 201203


Contact Us

China: +86 21 5132 0088
US: +1 650 419 9974
Europe: +45 4586 9000
Japan: +81 03 5403 6975