• Lead the group to meet the preset goal/budget of corporation R&Danalytical platform through streamlining/optimizing the analytical workflow and maximizing the operation efficiency while maintaining full compliance.
• Responsible for the analytical method development, pre-validation and validation.
• Guarantee all method development and validation accomplished on time.
• Review and approve analytical procedures and reports such as equipment confirmation, analytical method development and method transfer.
• Develop/build a world class analytical development and QC team including planning, recruiting/hiring, coaching/mentoring, and training for staffs and group leaders.
• Provide technical guidance/direction to subordinators as well as evaluate new analytical technologies to enhance R&D capabilities;
• Participate in partnering evaluation activities and provide insights from analytical perspective.
• Ph.D. degree or equivalent in Analytical Chemistry 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 analytical 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。
