Associate Director Process Design and Advanced Analytics

Tasks

• Apply Quality by Design
• Apply mechanistic modeling
• Approve regulatory source documents
• Author technical protocols
• Collaborate with analytical teams
• Coordinate stakeholder activities
• Create PPQ documentation
• Define project timelines
• Design experimental studies
• Develop Digital Twin strategies
• Develop process characterization plans
• Evaluate machine learning for process monitoring
• Implement Process Analytical Technology
• Investigate process optimizations
• Lead digital solutions with IT and Data Science
• Lead screening studies
• Lead technology transfer programs
• Oversee budgets
• Oversee data quality standards
• Oversee robustness testing
• Perform multivariate data analysis
• Prepare comparability packages
• Provide lifecycle management direction
• Review regulatory filings
• Support BLA authoring
• Support IND authoring
• Support continuous process verification
• Track project risks
• Troubleshoot study execution issues

Perks/Benefits

• Employee assistance programme
• Flexible benefits
• Free Company Bikes
• Healthcare plan
• Hybrid working model
• Local Nursery Agreement
• On-site canteen
• Pension plan
• Shuttle service
• Tax assistance
• Vacation services and vaccination clinic

Skills/Tech-stack

Analytical technology | Assay Development | Biologics | Budget Management | By Design | CAR-T | Cell and gene therapy | Continuous process verification | Data Analysis | Data Integrity | Design of Experiments | Digital Twins | Downstream processing | GMP | Gene Therapy | ICH Q10 | ICH Q8 | ICH Q9 | IoT | Machine Learning | Mechanistic modeling | Method qualification | Method validation | Multisite Program Management | Multivariate Data Analysis | Process Analytical Technology | Process Verification | Process characterization | Process validation | Program Management | Quality by Design | Regulatory writing | Risk Management | Statistical Analysis | Technology Transfer | Upstream Processing