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

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