亚新体育平台-亚新体育官网

抗体工艺经理(MAB) 部门:CMC  工作类型:FTE
工作地点:Suzhou
立即申请
职位申请

Responsibilities

  • Responsible for CMC function of large molecule at different stages of tech transfer, process development, clinical manufacturing, late-phase process development, product characterization and process validation
  • Monitoring and controlling the entire process of CMC Development of large molecule through collaboration with CRO/CMOs, and ensure it to align with the timeline, deliverables and acceptance criteria, and to follow the GMP and regulatory requirements
  • Leading presentation and discussion of each CMC function of large molecule; accountable for action item follow up
  • Involved in reviewing of all CMO documents of large molecule from protocols to records and reports, to ensure the scientific logic, integrity, traceability of documentations
  • Working both internally with CMC team members and externally with CRO/CMOs to proactively identifies, resolves or mitigates risks or issues; communicates openly and timely on project specific priorities

Qualification

  • Bachelor degree or above, with at least 5 years biologics drug development experience in one or multiple fields of upstream/ downstream/ analytical/ formulation/ Quality assurance of CMC development and prior experience in supporting pre-clinical and/or clinical stage drug development programs
  • Familiar with CFDA, FDA drug development, registration and other regulatory documents, and ICH guidelines
  • Fluent English (oral and writing) is preferred
  • Anticipate/ identify problems and takes appropriate action to correct
  • Good organization, coordination and communication skills

欢迎大家推荐

简历投递邮箱:zhangtianzhen@cstonepharma.com