Associate Director, Mass Spectrometry, Translational Biomarkers and Bioanalytics

Tasks

• Apply regulatory principles to validation and documentation
• Assess biomarker feasibility
• Contribute to biomarker strategy
• Coordinate matrix team deliverables
• Design and deliver bioanalytical work
• Ensure compliant bioanalysis delivery
• Lead bioanalytical strategy
• Lead biomarker development implementation
• Manage bioanalytical lifecycle management
• Manage data integrity and deviations
• Oversee method development optimization and validation
• Partner with Quality for vendor qualification and audits
• Perform immunogenicity risk assessment
• Plan assay validation approaches
• Plan cross border shipment and export
• Provide input to clinical documents
• Provide scientific oversight of bioanalytical vendors
• Recommend biomarker technologies
• Represent Translational Biomarkers and Bioanalytics
• Respond to health authority requests
• Review biomarker results
• Review immunogenicity results
• Review pharmacokinetic results
• Review statistical analysis plans
• Support clinical sample testing
• Support inspection readiness
• Support regulatory submissions
• Support sample collection storage and chain of custody

Perks/Benefits

• Hybrid work

Skills/Tech-stack

Bioanalytical Chemistry | Biomarkers | Cell-based assays | Chain of Custody | Clinical trials | Corrective and Preventive Actions | Data Integrity | Deviation Management | Documentation | Flow Cytometry | Genomics | Immunoassays | Immunogenicity | Immunology | Investigation New Drug Applications | Laboratory practices | Liquid Chromatography | Mass Spectrometry | Method validation | Pharmacokinetics | Preventive actions | Regulatory Submissions | Sample handling | Tandem Mass Spectrometry