Description
SUMMARY OF QUALIFICAITONS * Global and domestic cGxP operation, quality and packaging experience in medical/precision and diagnostic devices, pharmaceuticals and biomedical industries * Managed Chemistry and Manufacturing Controls: including API sourcing, vender/raw material qualification, formulation, product/process development, scale-up, clinical supplies, technology transfer and validation * Wrote and compiled CMC portions of IND, NDA and ANDA to support regulatory filing * Project manager and team leader of multi-disciplinary project teams for solid dosage forms, semi-solids, liquids, suppositories, soft/hard gelcaps, foam, spray, pouches, aerosols and soaps * Supervised product transfer of combination, healthcare, consumer OTC and Rx products to EM * Real time investigational experience as a Principal Manufacturing Technical Investigator for Consent Decree (CD) site of parenteral and generic marketed finished products * Team Lead oversight for 483 responses, FDA warning letter remediation, CD of Permanent Injunction ("Consent Decree") with successful certification within Sites work plan * Subject Matter Expert (SME) for non-conformance investigations, root cause identification, CAPA implementation, global change controls, serious complaints, validation and shop floor mentoring * Six Sigma Yellow, Green Belt RVCC - Six Sigma Black Belt Program candidate at Villanova University * Domestic and global travel in the USA, Canada, Puerto Rico and India
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