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

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简历投递邮箱：zhangtianzhen@cstonepharma.com