職位描述
職位描述：
崗位職責:
? Lead the group to meet the preset goal/budget of Simcere R&D analytical 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.
任職資格:
? 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 outstanding interpersonal skills are essential job requirements.
? Fluent in Mandarin and English.
