Position:
Director, Regulatory/QA. The Miami Project to Cure Paralysis & Neurosurgery at University of Miami, Miller School of Medicine
Work:
University of Miami, Miller School of Medicine
since 2009
Director, Regulatory/QA. The Miami Project to Cure Paralysis & Neurosurgery
University of Miami, Miller School of Medicine
2006 - 2010
Director, Biotechnology Resources. Office of Dean for Research
Biopharm Technology Services
- USA & EU 2003 - 2008
Independent Consultant
GlaxoSmithKline
2001 - 2003
Technology Manager, Biopharmaceutical Operations
GlaxoSmithKline
1998 - 2000
Manger
SmithKline Beecham
Apr 1996 - Dec 1998
Validation Engineer / Investigator
Education:
University of Miami - School of Business 2012 - 2013
University of Pennsylvania
Rutgers, The State University of New Jersey-New Brunswick
Skills:
Cell Therapy, Product Development, Biotechnology, Pharmaceutical Industry, Regulatory Affairs, Biopharmaceuticals, Quality Assurance, Project Management, IND, Program Management, Lifesciences, GMP, GLP, GCP, FDA, CMC development, Biologics, Medical Devices, FMEA, Six Sigma, User Requirements, IQ/OQ/PQ, Change Control, Deviation Management, PDLC, Validation, Batch Records, Quality Auditing, Cross-functional Team Leadership, Sop