Job Opportunities

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。