CMC Analysis/QC Director
Job Title: CMC Analysis/QC Director
Report to: CMC Head
- Directing teams in the biological characterization of protein drugs, routine physicochemical analysis, and package material analysis.
- Directing/responsible for the development, optimization and validation of analytical methods for protein drugs.
- Responsible for the construction and management of the protein drug analysis team.
- Complete other work tasks as assigned by the supervisor.
- Responsible for establishing QC team.
- Responsible for establishing company product quality analysis/quality management system.
- Responsible for product technology transfer and establishing product quality standards.
- Responsible for the company’s product analysis and quality control.
- Responsible for the quality supervision of the company’s R&D, production and inspection process.
- Responsible for/involved in IND & NDA declaration of CMC information writing.
- Ph.D. in biochemistry, analytical chemistry, medicinal chemistry or related fields, M.S. or equivalent education or experience.
- Familiarity with various types of protein drug analysis instruments and extensive experience in protein drug characterization and physicochemical analysis.
- Familiar with GMP/GLP and can guide/conduct method development, sample analysis and data management in a compliant manner
- Strong sense of responsibility and stress tolerance, with good English communication skills.
- Extensive international pharmaceutical industry resources, strategic thinking and efficient execution, proactive, flexible and result oriented.