Area: Shanghai
Department: CMC
1、Build and lead a team to develop, qualify/validate, transfer analytical methods for biological drug products. Perform sample analyses to support process development and lot release. Set phase appropriate product specifications.
2、Ensure good record keeping, including accuracy and traceability of raw data.
3、 Author and review relevant IND sections. Support on-site inspections.
4、 Lead the team to establish and optimize technology platforms, including but not limited to management of document system, management and maintenance of equipment, and technical training of employees
5、Coordinate work within and between departments, review experiment data, and solve technical problems.
1、Doctoral degree in pharmaceutical sciences, analytical chemistry, biochemistry, or relevant field.
2、 ≥ 8 years of experience in analytical method development in pharmaceutical/biotech industry, GLP/GMP experience is a plus
3、Familiar with relevant regulations, such as ICH, Chinese Pharmacopoeia and United States Pharmacopoeia. Has relevant experience in IND submission.
4、Hands on experience with commonly used analytical instruments, method development, qualification/validation and transfer. Proven ability to motivate and guide junior staff.
5、Proficient in written and spoken English
6、Good team player, strong communication skills, ability to work in a fast paced environment.
