CMC Analysis/QC Director
Department: CMC
Job Title: CMC Analysis/QC Director
Report to: CMC Head
Location: China
MAIN REPONSIBILITIES:
- 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.
QUALIFICATIONS:
- 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.
岗位职责：
- 指导团队进行蛋白药物生物表征、常规理化分析以及包材分析；
- 指导/负责蛋白药物分析方法的开发、优化与验证；
- 负责蛋白药物分析团队的建设和管理。
- 完成上级领导交代的其他工作任务。
岗位要求：
- 生物化学、分析化学、药物化学或相关领域的博士，硕士或相同学历或经验；
- 熟悉各类蛋白药物分析仪器，具有丰富的蛋白药物表征和理化分析经验；
- 熟悉GMP/GLP，可以合规的指导/开展方法开发、样品分析和数据管理等工作
- 责任心和抗压能力强，具备良好的英文沟通能力。
- 有广泛的国际医药行业资源，具有战略思维和高效执行力，积极灵活，结果导向。
