Principal Scientist Bioanalytics

Tasks

• Coach bioanalytical team members
• Define bioanalytical strategies
• Develop and validate PK PD assays
• Develop and validate immunogenicity assays
• Ensure alignment with global regulatory expectations
• Ensure process execution and inspection readiness
• Lead bioanalytical activities for clinical programs
• Manage outsourced bioanalytical work
• Prepare regulatory bioanalysis documentation
• Represent bioanalytics in regulatory meetings
• Serve as bioanalytics subject matter expert

Perks/Benefits

• Onsite work requirement
• Relocation to Belgium if needed

Skills/Tech-stack

Binding assays | Bioanalytical method development | Bioanalytical method validation | Bioanalytical regulatory documentation | Data Integrity | GCLP | GCP | Immunogenicity | LC-MS | Ligand binding | Ligand binding assays | Method Development | Method validation | PK/PD | Quality Compliance | Regulatory documentation | Regulatory strategy