Principle Consultant, Technology And Commercialization
CurrentDeveloped compliant, Elemental Impurities Risk Assessment for Topical Drug ProductPerformed Design History File gap assessment and remediation for table-top bioreactorDeveloped commercial aseptic bag-filling and sealing processDrove program recovery for Qualification and subsequent Clinical Manufacturing readiness for T-cell therapy manufacturing facilityLed Project Management assessment and identified schedule risks requiring mitigation via immediate implementation of additional controlsIdentified late-stage clinical and commercial contract management candidates for device assembly and development of osmotic tablet production for a drug-device combination productRetrospectively estimated quality risk of proposed cycle time reduction to the commercial vaccineLed development, implementation and integration of device controls into an existing drug-product Quality Management SystemLeading development and implementation of ProPharma Group’s Process Optimization offeringLed hard gel encapsulation process characterization at clients CMO in preparation for production of Phase III supplies and commercial manufacturing of Orphan/Breakthrough therapyLed commercial CMO selection processes including screening, RFP’s, interviews, proposal evaluation, ranking, and final candidate selection for orphan, microneedle-delivery and oral solution productsManaged compound pharmacy facility renovation to comply with new regulatory requirementsLed technology transfer program for abuse-deterrent solid dose hydrocodone formulation, including multi-continental manufacturing and analytical transfer from formulation developer to commercial CMOLed a team of cell culture growth media manufacturer Subject Matter Experts through detailed Manufacturing Quality Risk Assessment executed over a 5-day periodDeveloped Supply Chain and Mfg Management for world-wide commercialization of an injectable medication indicated for an orphan non-infectious inflammatory eye disease
