Bioanalytical Lead, London

Tasks

• Author IND bioanalytical sections
• Author investigator brochure sections
• Coordinate with regulatory agencies
• Define bioanalytical strategy
• Design validate and transfer PD assays
• Design validate and transfer PK assays
• Design validate and transfer immunogenicity assays
• Ensure GLP and non GLP assay compliance
• Ensure chain of custody for samples
• Integrate bioanalytical data into predictive models
• Lead biomarker assay development
• Manage CRO partners
• Manage sample logistics cold-chain stability and shipments
• Oversee biomarker assay validation
• Review regulatory documents
• Select qualify and manage CROs
• Troubleshoot assay anomalies

Perks/Benefits

• Hybrid work
• In-office 3 days per week

Skills/Tech-stack

Assay Development | Assay validation | Bioanalytical Assay | Bioanalytical assay development | Biomarker assays | CRO Management | Chain of Custody | Cold Chain | Cold-chain logistics | EMA regulations | Export Compliance | FDA Regulations | Flow Cytometry | GLP | ICH Guidelines | Immunogenicity assays | Import export compliance | Import/export | LC-MS | LC-MS/MS | MS/MS | Model Integration | Non GLP | PKPD assays | Stability Studies