The main responsibility of this role is to provide project overarching analytical support within the China organization and serve as a local interface for all clinical and commercial CMC project teams with Chinese collaboration partners, CDMOs, and vendors
Job Summary
The main responsibility of this role is to provide project overarching analytical support within the China organization and serve as a local interface for all clinical and commercial CMC project teams with Chinese collaboration partners, CDMOs, and vendors.
Specific tasks of this position include engaging directly with local collaboration partners, CDMOs, vendors, etc. to facilitate analytical transfers and support quality control for mAb and ADC projects.
This role also involves supporting operational & troubleshooting activities on-site.
Matching Summary
The main responsibility of this role is to provide project overarching analytical support within the China organization and serve as a local interface for all clinical and commercial CMC project teams with Chinese collaboration partners, CDMOs, and vendors.
Skills & Requirements
Must-have
Analytical transfers for mAb and ADC projects
On-site operational support at CDMOs
Quality control for biologics
Regulatory guidelines for analytical methods
GMP knowledge and regulatory filings
Nice-to-have
Cross-functional CMC team collaboration
Communication of complex technical matters
Knowledge in small molecule analytics
Key Requirements
Master's degree or PhD in relevant scientific field
At least 5 years of relevant professional experience
Proven experience in protein and ADC analytical technologies