• Lead the group to meet the preset goal/budget of corporation R&Dprocess chemistry platform through streamlining/optimizing the workflow and maximizing the operation efficiency while maintaining full compliance.
• Define chemistry project team objectives, timelines, and work. Provide technical support to identify and solve the synthetic and medicinal chemistry problems to advance the project.
• Responsible for the process development, pre-validation and validation.
• Guarantee all process development and validation accomplished on time.
• Review and approve process chemistry procedures and reports.
• Develop/build a world class process chemistry development 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 process technologies to enhance R&D capabilities;
• Participate in partnering evaluation activities and provide insights from process chemistry perspective.
• Ph.D. degree or equivalent in 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 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。
