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Click here or scroll down to respond to this candidateCandidate's Name
Street Address . C: PHONE NUMBER AVAILABLE EMAIL AVAILABLESummary: Four years of Laboratory and Formulation research experience identifying, implementing and maintaining quality systems in support of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) for operation systems. Knowledge implementing and support of FDA 21CFRPart 210/211. Participated in audits (internal/external) for regulatory compliance. Composed and reviewed complaints, Corrective action Preventive Action (CAPA) investigations and audits responses. Composed and reviewed Standard Operating Procedures for batch scale-ups and troubleshooting.EDUCATION AND TRAININGUrology Postgraduate Research 8/2014 - 6/2015St Elizabeth Medical Center Boston, MAParticipated in treatment studies of prostate cancer and recovery time following surgery.Followed treatment response of non-surgical patients vs. surgical patients.Compare surgical treatment modalities: Robotic-assisted vs. openGeneral Surgery Postgraduate Training 7/2010 - 6/2013Albert Einstein College of Medicine / Montefiore Medical Center Bronx, NYGeorge Washington University Hospital Washington, DCDoctorate of Medicine 11/2008Ross University School of Medicine Miramar, FLBachelor of Science, Biology Major /Chemistry MinorPace University Pleasantville, NYGenetic Linkage Experiment using drosophila melonogaster (fruit fly) to establish x-linked phenotypic / genotypic characteristics of progeny generations.Developmental Growth Study of chick embryos to study the effects of folic acid in the prevention of neural tube defects in mammals.Small Animal Surgery (nervous system dissection study)Microbiological studies emphasizing transduction in bacteria (E. coli) using various phage vectors.Professional SkillsPossess knowledge of FDA Compliance.Ability to communicate clearly and effectively with Management and cross functional groups.Strong organization skills.Ability to establish and maintain effective interpersonal relationships.Proficient in Microsoft Office (Word, Excel, PowerPoint)WORK HISTORYConsumer Safety Officer 10/2015 - 8/2017Food and Drug Administration (FDA) Baltimore MDAdapted and applied investigative methods and negotiated techniques to conduct inspections and investigations of manufacturers and operationsDeveloped inspection procedures and techniquesCoordinated the review process of Food Safety for public consumptionAdvised industry, state and local officials and consumers on enforcement policies, methods, and interpretation of regulationsEvaluated food product facility compliance issues under applicable CGMP regulations and other legal requirements, and participated in formulating new regulations, procedures and programs with national and international impact.Postgraduate Research Urology/Oncology 6/2014 - 6/2015St Elizabeth Medical Center Boston, MAParticipated in treatment studies of prostate cancer and recovery time following surgery.Followed treatment response of non-surgical patients vs. surgical patients.Compare surgical treatment modalities: Robotic-assisted vs. openSurgery Postgraduate Training 7/2010 - 6/2013Albert Einstein College of Medicine / Montefiore Medical Center Bronx, NYGeorge Washington University Hospital Washington, DCClinical ExperienceManaged patients for preoperative and postoperative care.Assisted Attending surgeons in various surgical procedures using laparoscopic vs. open approach.Performed physical exams Reviewed and interpreted laboratory results and imaging studies to diagnose and treat patients.Formulation Research Scientist (R&D) 8/1998-5/2002Wyeth Pharmaceuticals (PFIZER) Pearl River, NYApplication of coating technology to pharmaceutical productsAnalysis and optimization of coating parameters.Documentation (developed reports detailing work completed and Standard Operating Procedures (SOPs) according to written procedures).Performed sampling of products before and after compression.cGMP knowledgeable.Performed physical and analytical tests on finished products to ensure integrity.Collaborated with senior scientists on troubleshooting, regulatory affairs, scale-up, and FDA submission and release.TECHNICAL SKILLSBacterial cell culture ChromatographyUV-vis spectroscopy Microscopy (fluorescent, electron)Karyotype Flow cytometryGel electrophoresisPERSONALMilitary (U.S. Navy - Honorable discharge) |
