Developed 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

Developed and implemented quality risk-management program (ICH Q9)Developed and implemented site-wide quality event investigation process, resulting in improved compliance, cycle time and cost effectivenessDeveloped and implemented environmental monitoring program including establishment of alert and action limits, and quality system procedures governing excursionsDeveloped and managed raw material sampling, physical testing, and disposition process for Phase 3 clinical manufacturing operationReviewed and approved criticality assessments, SOP’s, change controls, product impact assessments, qualification protocols, and reports

Led technical development of Process Qualification, Cleaning Verification and Process Validation protocols in preparation for pre-approval inspection and launchManaged issuance and post-execution review of controlled clinical manufacturing documentation Provided day-to-day technical support and trouble-shooting for clinical manufacturing Developed manufacturing equipment SOPs including startup, start-up challenges, operation, and cleaningLed development and characterize a commercial powder filling processTechnical lead for commissioning of all process equipment, clean room and clean utility systems of new manufacturing facilityProvided technical and program compliance review and approval for all qualification protocols/final reports

Johnson & Johnson, Vacaville, CA, Operations Excellence Leader, 9 YearsJohnson & Johnson, Vacaville, CA, Improvement Leader Production Manager 3 MonthsJohnson & Johnson, Vacaville, CA, Product Commercialization Mgr, Transdermal Mfg. – 1 YearALZA Corporation, Vacaville, CA Senior, Process Engineer, Transdermal Manufacturing - 4 Years