- Prepares specifications for new equipment, prepares draft-operating procedures and supports validation to coordinate scale-up and validation activities.
- Identifies critical process parameters and input (raw) material attributes that must be controlled to achieve critical material (quality) attributes. Uses Risk assessments to prioritize process parameters and material attributes for experimental verification.
- Utilizes Design of experiments (DOE), risk assessment, and process analytical technology (PAT) as tools in the QbD process when appropriate.
- Establishes control strategies for the entire process that may include input material controls, process controls and monitors, design spaces around individual or multiple unit operations, and final product tests.
- Generates stability data according to ICH guidelines that demonstrates product meet quality attributes in line with user requirements and product shelf life.
- Coordinates required reports, specifications and technical documentation for project phase completion and Regulatory submission packets
- Transfers new equipment and processes to commercial manufacturing