Process Improvements

Experience

  • Identification of process improvements and implementation into a cGMP environment.
    • Identified a new operations model that increased production by 50% without increasing headcount at the Seal Beach IMF.
    • Supported tech transfer, implementation, training, and comparability runs for the Provenge Automation Project.
    • Identified a sporicidal cleaning agent that could reduce incubator cleaning costs by 73% and overall costs by 58%.
    • Identified and corrected an incorrect operator technique that would have negated a significant portion of ~$1 million cost savings associated with the antigen waste and variability reduction project.

    • Supported weekly Medical Affairs Patient Rounds meetings and identified/implemented a method to proactively prevent patient lot failures due to low cell counts.

    • Supported the identification and introduction of new technologies such as the NC 200 automated cell counter, UniFuge single-use semi-continuous centrifugation system, and Smart-Max automated thawing device.

    • Implemented plant dedicated shoes to mitigate the risk of bacillus and reduce contamination risk.