Senior Manager, Bioanalysis
Core
Lead bioanalysis activities for China clinical development, coordinating between global teams and local CROs to ensure on-time delivery of regulatory-compliant data.
Role type
Senior Manager, Bioanalysis
Builds
Bioanalysis strategies, validated analytical methods, and regulatory submissions for clinical studies in China.
Domain
Biopharmaceuticals, Clinical Development, China Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulated bioanalysis (small/large molecules), CRO management, China regulatory compliance (NMPA/HGRAC), GLP/GCP, method validation, sample exportation justification
Preferred skills
CDE/FDA submission experience, protein therapeutics/biomarkers expertise, cross-functional stakeholder management
Technologies
None explicitly listed
Responsibilities
Coordinate China bioanalysis strategy with global and local teams; oversee CROs for sample analysis and data transfer; initiate method transfer and validation for protein therapeutics and small molecules; ensure compliance with GLP/GCP; manage biosample exportation justification; review and translate external lab documents; report writing and data transfer.
Seniority
Senior Manager, hands-on leadership
