Senior Director, Analytical Development and Quality Control

Tasks

• Coordinate external QC operations
• Define analytical development and quality control strategy
• Develop analytical organization and team leadership
• Drive inspection readiness
• Ensure GMP readiness
• Establish analytical control strategies
• Lead analytical development and quality control execution
• Lead batch data review investigations deviations OOS OOT CAPAs change control
• Lead reference standard management
• Lead technology transfers and process changes
• Manage GMP documentation review and approval
• Manage external partner performance KPIs
• Manage method lifecycle management
• Manage specifications and comparability assessments
• Oversee release and stability testing
• Perform health authority response support
• Support IND BLA and IMPD submissions

Perks/Benefits

• N/A

Skills/Tech-stack

Analytical Chemistry | Analytical Method Development | Binding assays | Biologics | CAPA | CMC | Change Control | Charge variant analysis | Chromatography | Comparability | Data Integrity | Drug Product | Drug Substance | Electrophoresis | Fusion Proteins | GMP | Health Authority | Health authority interactions | Inspection Readiness | KPI Management | Method Development | Method qualification | Method validation | Monoclonal antibodies | OOS | OOT | Potency assays | Protein characterization | Purity analysis | Quality Control | Recombinant Proteins | Reference standards | Regulatory Submissions | Size Variant Analysis | Specifications | Spectroscopy | Stability Indicating Methods | Stability Testing | Technology Transfer | Variant analysis