• Lead the group to meet the preset goal/budget of corporation R&Dformulation platform through streamlining/optimizing the formulation workflow and maximizing the operation efficiency while maintaining full compliance.
• Plan, co-ordinate, and oversee the work activities of scientific staff within the formulation group. Provide technical guidance to group leaders and troubleshoot personally on the shop floor where necessary to ensure smooth progress of projects.
• Be responsible for the oversightofthe review and preparation process for batch records, formulation development report, and/or the other documentation related to formulation and process development works to ensure completion with high quality. Ensure all deliverables provided on time.
• Build new capabilities within the formulation group, by building up team and by evaluating new technologies/ equipment which can bring value to Simcere;
• Develop/build a world class formulation development team including planning, recruiting/hiring, coaching/mentoring, and training for staffs and group leaders.
• Participate in partnering evaluation activities and provide insights from analytical perspective.
• Ph.D. degree or equivalent in Pharmaceutical science or other directly related science discipline with pharmaceutical industry experience of 8 - 10 years;
• Excellent managerial skill in both people and projects being able to lead a large group of scientific staffs and a large portfolio of development programs.
• Must be familiar with requirements of FDA, EMA and CFDA regulations, ICH guidelines and GMP/GLP as well as drug product development process.
• Experience of generic drug development highly preferred.
• Problem solving ability and adept handling of process chemistry teams is also required.
• Strong communication skills, both written and verbal, and outstandinginterpersonal skills are essential job requirements.
• Fluent in Mandarin and English.
大型制药集团，需要有欧美巨头总部管理经验，薪资可谈。
