Associate Director, Early In-Process Analytics, Biotherapeutics Process Development, Pharmaceutical Sciences

Tasks

• Collaborate with Global IPA to harmonize methods and reporting
• Define strategy standards and testing plans
• Design and execute analytical experiments and testing plans
• Drive continuous improvement in analytical workflows and data management
• Ensure data integrity and sample chain of custody
• Lead and develop multidisciplinary laboratory team
• Lead early in process analytics function
• Manage method transfer and implementation
• Oversee method qualification verification and validation
• Prepare technical reports and regulatory documentation
• Support automation and digitalization commissioning and qualification

Perks/Benefits

• N/A

Skills/Tech-stack

Analytical technology | CGMP | Chromatography | Data Integrity | Data Management | Data Management Systems | GMP | Laboratory automation | Lifecycle Management | Management systems | Mass Spectrometry | Method Lifecycle | Method Lifecycle Management | Method qualification | Method transfer | Method validation | Method verification | Process Analytical Technology | Spectroscopy | Troubleshooting