Manufacturing

Development of strategy and approach to streamline manufacturing efforts
Assistance with Facility design
Master planning, scheduling and tracking of manufacturing start-up efforts
Composing and reviewing manufacturing documents, including:
- Development/Pilot scale characterization protocols and reports
- SOPs, batch records, and related GMP documents
- Process Flowcharts
Troubleshooting differences in process performance/product qualities at different scales
Risk assessments of manufacturing methods
Tolerance/Specification development and parameter classification
Technical investigation of deviations and out-of-specification results
Hands-on assistance during manufacturing start-up activities (person in plant)
Process and related equipment validation, including utilities, computer systems and other automated systems
Planning and performing equipment calibrations
Writing and review of documents for global regulatory submissions
Long-term planning and process feasibility (Project Management)