Summary
Overview
Work History
Education
Skills
Timeline
Generic

MARGOLITE CÉSAR, PhD

SUN CITY CENTER

Summary

Accomplished professional with over 15 years of experience in research, infection disease, regulatory compliance, and data analysis. Specializing in assessing health impacts of environmental chemicals with expertise in risk assessment, technical writing, and method validation. Skilled in utilizing advanced statistical techniques and geospatial analysis to inform decision-making and enhance public health outcomes.

Overview

18
18
years of professional experience
2019
2019
years of post-secondary education

Work History

EPIDEMIOLOGIST

FDA
10.2022 - 05.2025
  • Review product complaints and adverse event (AE) report in cosmetics ingredients and products determining if they were serious or non-serious.
  • Assist in guiding management and other personnel on cosmetic ingredients that require review and epidemiological studies.
  • Send any report that needs corrections to Signal Management Branch.
  • Search for AEs associated with specific companies, products, brands, etc.
  • Serves as a member to consider problems or directions in safety evaluation and regulation of cosmetic products and ingredients. For instance, analyze AEs associated with specific ingredients, products, brands, concerns such as hair loss, and product effects such as skin lightening.
  • Perform epidemiological reviews of epidemiologic studies that are identified as relevant to cosmetics. For instance, evaluation of epidemiological data relating to the degree of hazard associated with contaminants and toxicant present in cosmetics and evaluation of pertinent test results from cosmetic products to determine contamination and possible adverse effects on consumers.
  • Participate in cosmetic product and ingredient risk assessments by providing scientific advice and technical assistance on various tasks, including reviewing the study design, methodology, and conclusion of relevant epidemiological and clinical studies.
  • Participate in cross-function working group, regulatory task forces initiatives focused on enhancing the cosmetic regulatory program effectiveness.
  • Review the epidemiological studies in the Cosmetic Ingredient Review document to evaluate studies and information using applicable data and information sources.
  • Write Memorandum, and prepare reports, summaries, and presentations upon request, explicitly focusing on targeted products.
  • Provide customer service to support other projects.

LEAD EPIDEMIOLOGIST

Manatee County’s Prevention Coalition
05.2022 - 02.2023
  • Implement data collection protocols that enhanced reporting accuracy, resulting in noticeable improvements in health intervention effectiveness.
  • Work with community partnerships and taskforce that implement comprehensive, evidence-based environmental strategies to prevent and reduce substance abuse while promoting health and wellness throughout the county, especially among youth.
  • Partner with local health authorities to develop targeted health campaigns, fostering community engagement and reducing disease incidence.
  • Spearheaded the integration of advanced statistical software in data analysis, streamlining processes and enabling timely decision-making.
  • Developed and executed training programs for staff, improving data collection efficiency and achieving measurable gains in reporting accuracy.
  • Introduced geospatial analysis techniques to identify health trends, resulting in targeted interventions that effectively addressed community needs.

SCIENTIST, RESEARCH AND DEVELOPMENT (CONTRACTOR)

Catalent Pharma Solution
11.2021 - 09.2022
  • Develop methods and validate instruments used to measure the residues on the surfaces of the manufacturing equipment.
  • Develop analytical method validation protocols to support the transition to cGMP testing client products according to Catalent SOPs, policies, cGMPs, and regulatory guidelines.

LEAD EPIDEMIOLOGY, BIOLOGICAL SCIENTIST IV

Florida Department Health
09.2020 - 11.2021
  • Perform descriptive and analytic epidemiologic investigations involving cases, clusters, and outbreaks of COVID-19.
  • Study scientific, systematic, and data-driven of the distribution and determinants (causes, risk factors) of health-related events in specified populations (healthcare facilities, neighborhoods, schools, cities, states, countries).
  • The facility expert for COVID-19 and reportable disease works closely with the community's local health department and other healthcare facilities regarding infectious diseases and MDROs.
  • Provide educational in-service as needed regarding COVID-19 or MDROs, new policies, and new practices regarding COVID or MDROs.
  • Develop and interpret reports for infectious disease, MDROs, and COVID-19 surveillance using charts and graphs to convey information to support decision-making.
  • Work closely with the Director of Nurses and Nurses Managers regarding increased rates and the need for creating an action plan based on the increasing and decreasing hang hygiene and personal protective equipment (PPE) rates.
  • Responsible for conducting case investigations and interviews, contact tracing, prompt implementation of appropriate control measures, coordinating the shipment of laboratory specimens to BPHL, case documentation and timely reporting, research, and public health surveillance, and field epidemiological investigations of disease clusters, outbreaks, and individual cases of COVID-19 and infectious disease.
  • Conduct continuous public health surveillance, including monitoring Merlin task lists, disease reports, and other mechanisms for tracking the incidence of reportable diseases.
  • Write, Prepare, and review technical reports, summaries of investigations, and scientific papers and performs related work as required.
  • Provide support and direction to the Department of Health in Manatee County, local clinics, hospital infection control staff, private physicians, laboratories, nursing homes, community partners, and other facilities concerning early detection of COVID-19 and appropriate prevention and control measures.

Certified Clinical Research Associate

Virb Inc.
09.2020 - 03.2021
  • Conducted pre-study visits and produced detailed reports.
  • Conducted thorough validation of materials and data to ensure clinical trial integrity.
  • Enhanced trial management efficiency by refining site assessment procedures and patient consent documentation,
  • Conducted site visits to evaluate protocol adherence and ensure compliance with regulations.
  • Addressed concerns to maintain effective collaboration between sponsors and research sites.

INFECTIOUS RESEARCH SCIENTIST/TECHNICAL LEAD

Department of Agriculture
01.2019 - 09.2020
  • Analyze food samples for a variety of threat agents, including biological, chemical, and radiological substances.
  • Participate in targeted food surveillance programs (FERN) to identify potential threats in the food supply
  • Develop and validate new methods for food analysis.
  • Plan and conduct experiments; analyzes results of experiments and provide conclusions.
  • Organize, analyze data, and monitor the progress during the research projects.
  • Perform technical reviews on the quality and compliance of scientific data and reports.
  • Writes SOP.
  • Develop and review research grant applications; conducts detailed technical work; and manage all aspects of grants and proposals, including reporting.
  • Design and implement research projects in the laboratory that contribute to epidemiological investigation.
  • Conduct a surveillance system evaluation.
  • Train and supervise research personnel, and ensure staff is trained in the laboratory's current methodology and safety procedures.
  • Prepare and present data for publication in scientific meetings and conferences.
  • Stay current with the literature and regularly leads discussions of new reports pertinent to ongoing and proposed projects in regularly scheduled onsite laboratory meetings.
  • Prepare official reports and may be called upon to testify before the court or the Commissioner.
  • Utilize a Laboratory Information Management System (LIMS) for data entry and other computer operations.
  • Write SOPs and test methods; handles sample and performs analyses according to SOPs and test methods.
  • Sign reports as the department representative when delegated signature authority.
  • Maintained and calibrates equipment to report deficiencies or malfunctions to management.
  • Identify and record nonconformities on Corrective Action Requests; identifies and record potential nonconformities on Preventive Action Requests; take corrective action.

CHEMIST III/COORDINATOR

Florida Department of Agriculture & Consumer Services
06.2013 - 09.2018
  • Perform administrative quality review of result data, which are outputs to project managers in decision making.
  • Performed laboratory analysis of water, food, milk, dairy products, and environmental specimens as assigned by all inspection and regulatory procedures.
  • Performed technical laboratory functions in compliance with regulatory agencies and food safety requirements.
  • Perform sample analysis using HPLC, pH meter, analytical and pan balances, automated extraction instrument, AAS, HPLC, LC/MS/MS, GC, inductively coupled plasma, refractometer, combustion analyzer.
  • Oversight of the section's database to ensure that data quality and mechanisms review data from the point of view of validity, reliability, timeliness, precision, and integrity.
  • Oversee a Proficiency testing (PT) program used in the food testing industry to verify that an individual laboratory can perform a given method.
  • Coordinate the testing event and notify appropriate administrative and lab personnel before the arrival of the samples, which helps to ensure all testing reagents and consumables are available and that the needed personnel are available on the days required.
  • Monitor a grant to maintain yearly payment schedules and balances.
  • Organize any rotational aspects of the Proficiency Testing plan (PT), report results, monitor deadlines, receive results, and initiate the corrective action process if needed.
  • Led cross-functional teams in research projects, fostering collaboration and innovation across departments.
  • Report the results to the PT provider and other laboratories within the network.
  • Identify and resolve problems promptly.
  • Gather and analyzes information skillfully.
  • Develop alternative solutions.
  • Monitor and evaluate the program.

GRADUATE STUDENT RESEARCH

Walden University
01.2013 - 05.2018
  • Design and execute a secondary research methodology to test the poverty rate and occurrence of foodborne illness risk factors in food entity.
  • Gather and collect data from the US Census American Community Survey block group.
  • Conduct a literature review search to reveal theoretical gaps in foodborne disease research.
  • Design and execute epidemiologically.
  • Mapp retail food listings and foodborne number of foodborne risk factors over poverty level using Geographic information systems (GIS).
  • Develop a theoretical framework to describe the broader relationship between the independent and dependent variables.
  • Perform statistical analysis on data analysis using Excel and SPSS/SAS.
  • Familiarize yourself with Institutional Review Board (IRB) approval procedures.
  • Apply statistical methods, including linear mixed models, mixed-effect logistic regression analysis, multivariate analysis, categorical data analysis, repeated measures analysis, and nonparametric analysis.
  • Collaborate with researchers from different fields in the development of manuscripts and abstracts.
  • Present data clearly and confidently to both small and large groups, at home or abroad.

CHEMIST II

Florida Department of Agriculture
01.2011 - 01.2013
  • Perform Complex sample preparation, chemical extraction, instrumental analysis, and special analytical procedures on samples to analyze pesticides, veterinary drugs, and other toxic chemical contaminants or residue.
  • To make pesticide risk assessment decisions, generate data to submit to the state monitoring program, USDA pesticide program, and food emergency response Network.
  • Perform complex instrumentation analysis of chemical residues utilizing various combinations of gas chromatography and liquid chromatography and other complex analytical instruments and data systems.
  • Perform sample analysis using HPLC, pH meter, analytical, and pan balances, automated extraction instrument, AAS, HPLC, LC/MS/MS, GC, inductively coupled plasma, refractometer, combustion analyzer.

CHEMIST II

Aveva Drug Delivery System
07.2007 - 01.2011
  • Train analysts on USP, EP, JP, and in-house methods and instrumentation.
  • Perform as a group leader during special group assignments.
  • Coordinate testing schedules and monitor the status of sample testing as assigned by the supervisor.
  • Perform Identification, Impurities, Related Substance, and Residual Solvents for Raw Material.
  • Execute Loss on Drying, Residue on Ignition, Titration Assay, Heavy Metal, Lead, Viscosity, NVC, Loss on Ignition, pH, Water Content, Arsenic, and More.
  • Method validation and method transfer for raw material testing.
  • Conduct experiments in the development/validation of robust, cost-effective manufacturing protocols and test methods.
  • Effectively manage activities associated with multiple, concurrent, and complex projects to deliver results on time.
  • Revise SOP or analytical method testing for quality assurance and control QC Chemist.
  • Supervise, coordinate and review work of a small staff of chemist and technicians on an ongoing basis as well as on a project basis.

CHEMIST II

Kirk Pharmaceuticals
01.2007 - 07.2007
  • Perform Analytical Assay, Impurity, Degradation, Dissolution testing, and Content Uniformity for stability and finished product.
  • Raw material testing of various solid dosage products Chemist (AR&D).

Education

DOCTOR OF PHILOSOPHY (PH.D.) - PUBLIC HEALTH, EPIDEMIOLOGY

Walden University
Indianapolis, Minnesota

BACHELOR OF SCIENCE (BS) - CHEMISTRY/BIOCHEMISTRY

University of Florida
Gainesville, FL

BACHELOR OF SCIENCE (BS) - ZOOLOGY

University of Florida
Gainesville, FL

Skills

Epidemiology

Data Analysis

Risk Assessment

Research

HPLC

GC/MS

SPSS

SAS

Microsoft Office

Laboratory Analysis

Quality Control

Method Validation

Technical Writing

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Timeline

EPIDEMIOLOGIST

FDA
10.2022 - 05.2025

LEAD EPIDEMIOLOGIST

Manatee County’s Prevention Coalition
05.2022 - 02.2023

SCIENTIST, RESEARCH AND DEVELOPMENT (CONTRACTOR)

Catalent Pharma Solution
11.2021 - 09.2022

Certified Clinical Research Associate

Virb Inc.
09.2020 - 03.2021

LEAD EPIDEMIOLOGY, BIOLOGICAL SCIENTIST IV

Florida Department Health
09.2020 - 11.2021

INFECTIOUS RESEARCH SCIENTIST/TECHNICAL LEAD

Department of Agriculture
01.2019 - 09.2020

CHEMIST III/COORDINATOR

Florida Department of Agriculture & Consumer Services
06.2013 - 09.2018

GRADUATE STUDENT RESEARCH

Walden University
01.2013 - 05.2018

CHEMIST II

Florida Department of Agriculture
01.2011 - 01.2013

CHEMIST II

Aveva Drug Delivery System
07.2007 - 01.2011

CHEMIST II

Kirk Pharmaceuticals
01.2007 - 07.2007

BACHELOR OF SCIENCE (BS) - CHEMISTRY/BIOCHEMISTRY

University of Florida

BACHELOR OF SCIENCE (BS) - ZOOLOGY

University of Florida

DOCTOR OF PHILOSOPHY (PH.D.) - PUBLIC HEALTH, EPIDEMIOLOGY

Walden University

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