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Position:
制剂研发总监或以上 Drug Formulation Director  

Employer:
Simcere Pharma Group

Description:

  • Lead the group to meet goal/budget of Simcere R&D formulation platform through streamlining/optimizing the formulation workflow and maximizing the operation efficiency while maintaining full compliance.

  • Supervise the formulation team activities. Provide technical guidance to group leaders and troubleshoot.

  • Supervise preparation for batch records, formulation development reports, and/or other formulation related documents and development plan to ensure high quality and delivered on time.

  • Increase capabilities by building teams and evaluating new valuable technologies/equipment.

  • Develop/build a world-class team of formulation development including planning, recruiting/hiring,

    coaching/mentoring, and training to staffs and group leaders.

  • Participate in partnering evaluation activities and provide insights from a formulation perspective.

  • 负责建立、领导和管理用于支持公司仿制药、新药产品管线的剂型开发团队

  • 通过预算管理,精简、优化配方工作流程,最大限度地提高运营效率,并保证合规

  • 计划、协调和科学制定组内员工的工作,并督促项目按期进行,同时为项目组提供必要的技术指导

  • 负责批记录的核查,制定发展报告和相关的其他文档制定及流程开发,确保高质量完成工作

  • 参与外部合作项目评估,并给予专业意见

 



Qualifications/Experience:

  • Ph.D. degree or equivalent in Pharmaceutical science or other directly related fields with 8 - 10 years’ experience in the pharmaceutical industry.

  • Excellent impersonal, problem solving and leadership skills.

  • Must be familiar with the requirements of FDA, EMA and CFDA regulations, ICH guidelines and GMP/GLP as well as drug product development process.

  • Experience in generic drug development highly preferred.

  • Must be fluent in Mandarin and English

  • 药物制剂专业博士学位,8-10 年以上就职于大型药企或全球研发公司相关专业领域的研发经验,有 仿制药开发经验者或 505(b)2 优先考虑

  • 具备优秀的管理能力和团队管理能力,有丰富的大型项目管理经验

  • 熟悉 FDA\CFDA 的要求,了解 EMA 和 CFDA 法规、指导方针和 GMP / GLP 以及药物产品开发过程

  • 具备很强的解决问题能力和专业技术能力

  • 具备良好的沟通和写作能力,普通话和英语流利

 



Location: Nanjing or Shanghai, China

Contact: Chen Chen (chen.chen@simcereusa.com)

Post Date: 11/6/2018 2:17:27 PM
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