A major pharmaceutical company is seeking a Scientist IV, Process Development individual.  The position is based in the Raleigh, NC area.  The process development scientist is directly responsible for the management and execution of Commercial Product support projects in the areas of product technical transfer, process improvement and optimization, scale-up, troubleshooting, and investigation support. Identifies and evaluates critical process parameters. Conducts studies, write protocols and reports in support of process validation activities. Designs, develops, and conducts studies to produce robust bio-equivalant formulations and processes.  Conducts analyses, writes reports to support filings, scale-up scientific papers and justification for changing processes. Responsible for transferring to Process Validation a robust, validatable formula and process to meet requirements of the Code of Federal Regulations.  Assists in development of process validation strategy for newly identified critical steps. Documents samples and test results.