Multilingual Masters of Bioscience student seeks to contribute vast skills, knowledge, and adaptable character to a scientific firm. Extensive laboratory experience including serving as project leader. Self-driven and highly motivated individual who wishes add value to the company through prior knowledge and experience.
*Languages: English, Creole
*Software: Microsoft Office, MatLab, R-Studio, Visio, Graphpad, Share Point
Keck Graduate InstituteResearch Assistant10/2015 to Current
Develop field-based diagnostics to allow for rapid identification of dengue virus infection.
System to detect DENV in whole blood.
Performed a combination of sample preparation, RT-LAMP, and detection in an integrated, closed-system, contamination controlled, and fully-automated format within a laboratory.
Perform analytical and clinical verification/validation.
Staar SurgicalRegulatory Affairs Intern06/2015 to Current
Review Materials related to changes or new products/claims including Manufacturing, Quality R&D, Clinical, and Marketing materials for: Compliance to applicable standards and regulations.
Applicability to Design History Files or Device Master Records.
Compliance to Regulatory Filings.
Verification of support related to that the intended use and claims.
Determination of regulatory submission requirements according to domestic and international regulations.
Develop/review procedures for compliance with the intent of EN ISO 13485, and 21 CFR 820 Participate in/Support Health Authority Inspections Review materials prior to presentation to investigators/ or response submissions Perform/participate in the following activities: Risk analysis, Root cause analysis.
University of Central FloridaResearch Assistant12/2011 to 08/2014
Mastered key laboratory skills: PCR, virus quantification, vector cloning, cell line maintenance, gel electrophoresis and extraction, histology, transfection, SDS-Page Mentored colleagues and staff members on preparation and designing bacterial vectors Managed quality, good laboratory practices, and good manufacturing processes Performed intracellular protein delivery using Chariot to PC12 cell lines Completed primary research on apoptotic pathways in ALS, molecular cloning, and effects of nitrated Hsp90 on various cell lines Projects Project Leader Keck Graduate Institute Oct-Dec '14 Aided a scientific liaison in team assessment of product market analysis for a cardiac medical device Defined potential business partners and specific financial goals to progress the medical product into clinical trials Outlined future phases of product development in order to end up on the medical devices market Project Leader Keck Graduate Institute Aug '14 Engineered 3D-printed tracheal stent via SolidWorks as a solution to a medical condition Administrated and delegated team tasks which included market analysis and device design Analyzed the quality and clinical aspects of the tracheal stent for patient safety and quality Presented results before colleagues and faculty and awarded 1st place in presentation competition.
University of Central FloridaProject Leader06/2012 to 08/2014
Designed, managed, and performed experiments alongside a team of undergraduate students of nitrated Hsp90 regarding MAP kinases in apoptosis Presented at national conferences: American Society of Cell Biology in New Orleans, LA, Nitric Oxide Annual Conference in Cleveland, OH Designed bacterial vector to see the FOXO3A element translocate in motor neurons and PC12 cell lines with the conjunction of luciferase activity to observe a signal Presented at the Annual Biological Research Conference in Nashville, TN Publications Nitration of Hsp90 on tyrosine 33 regulates mitochondrial metabolism".
Masters of Bioscience:Clinical and Regulatory AffairsMay '16Keck Graduate InstituteClinical and Regulatory Affairs
US Regulatory Affairs, EU Regulatory Affairs, Clinical Trial Design, Biostatics, CMC for Pharmaceuticals, Biopharmaceutical Quality Assurance and Control, Microbial Bioprocessing, Business of Biostrategy, and Corporate Finance
Fellowships: Hansen Endowed Fellowship '14 and Keck Graduate Institute Fellowship '14
BS:BiotechnologyMay '14University of Central FloridaGPA: McNair Scholar, Dean's List, Research and Mentoring Program (RAMP) Scholar, President of SACNAS chapter Fellowship: Research Scholarship Winner '13 and '14Biotechnology McNair Scholar, Dean's List, Research and Mentoring Program (RAMP) Scholar, President of SACNAS chapter Fellowship: Research Scholarship Winner '13 and '14
Parental Drug Association Student Chapter KGI, Nitric Oxide Society, American Society for Cell Biology, Society for the Advancement of Chicanos and Native Americans in Science, Research and Mentoring Programs, McNair Scholars Program
*Soft Skills: Quality by Design (QbD), Process Flow Diagrams, Clinical Trial Design, Investigational New Drug Application, 510K, Orphan Drug Designation
Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.
Companies Worked For:
Keck Graduate Institute
University of Central Florida
Keck Graduate Institute
University of Central Florida
Job Titles Held:
Regulatory Affairs Intern
Masters of Bioscience : Clinical and Regulatory Affairs May '16 US Regulatory Affairs, EU Regulatory Affairs, Clinical Trial Design, Biostatics, CMC for Pharmaceuticals, Biopharmaceutical Quality Assurance and Control, Microbial Bioprocessing, Business of Biostrategy, and Corporate Finance
Fellowships: Hansen Endowed Fellowship '14 and Keck Graduate Institute Fellowship '14 BS : Biotechnology May '14
Create a job alert for [job role title] at [location].