Maria C. Rojas
Atlanta,United States
Summary
Biotechnology Engineer with extensive experience in medical device project management at CDC, focusing on FDA-regulated manufacturing. Proven expertise in molecular diagnostics and SOP development, ensuring effective communication across teams. Successfully led the manufacturing of diagnostic kits, enhancing outbreak response capabilities in high containment environments. Demonstrated excellence in Quality Assurance compliance throughout all projects.
Overview
14
14
years of professional experience
Work History
Microbiologist III - Project Manager
CENTERS FOR DISEASES CONTROL AND PREVENTION
Atlanta, United States
12.2021 - Current
- Company Overview: ASRT inc. contractor for CDC /DCLSR / PROS/ Atlanta, GA, United States.
- Lead projects for the manufacturing of molecular diagnostic test kits, and medical devices for the surveillance and outbreak control of infectious diseases.
- Maintained accurate and comprehensive documentation of all manufacturing operations, maintenance activities, and safety inspections utilizing controlled documentation and forms.
- Performed non-research biological science work or biological science support work in various scientific and public health areas associated with numerous biological outbreaks.
- Performed work in High containment laboratories (BSL2+/enhanced containment laboratory) to effectively handle inactive biologic toxins and high-risk pathogens.
- Assisted in crafting new standard operating procedures, technical documents (e.g., laboratory aids and troubleshooting guidance) and training materials.
- Developed standardized calculating digital procedures to optimize the calculations sections of the standard operating procedures for the manufacturing of diagnostic kits and PCR single and multiplex associated calculations.
- Collaborated with, CDC Quality Assurance, CDC R&D, and other relevant teams implement the manufacture of new diagnostic testing kits for newly detected outbreaks compliant with FDA guidelines for medical devices.
- ASRT inc. contractor for CDC /DCLSR / PROS/ Atlanta, GA, United States.
Clinical Research Technician
RAYBIOTECH
Atlanta, United States
06.2021 - 10.2021
- Expressed COVID-19 proteins and variants, using transfected cell cultures for research and vaccine development.
- Conducted mammalian cell culture, maintenance, and passage.
- Performed mammalian cell transfection using transfection kits and vectors for protein expression.
- Extracted proteins by centrifugation, vacuum filtration, and FPLC with nickel columns.
- Determined DNA concentration using Nanodrop and SDS Page Gels.
- Analyzed proteins with SDS page protein analysis and Bio-Rad Bradford Protein Assay
Bilingual Customer Service Representative
GOLDFEIN CLAIMS MANAGEMENT
Atlanta, United States
06.2020 - 04.2021
- Reviewed, analyzed, and coded total loss vehicle insurance documents.
- Communicated with clients over the phone, both in English and Spanish to update and escalate issues related to their loss.
- Provided continuous interpretation, as well as document translation for the legal team.
Student researcher
COSTA RICA INSTITUTE OF TECHNOLOGY
Cartago, Costa Rica
01.2019 - 07.2019
- Company Overview: Thesis / Research Project opting for the Degree of Biotechnology Engineer/ Costa Rica
- Analyzed agro-industrial waste as a potential substitute for algae culture media, to implement an upscaling process for micro algae culture.
- Developed a scaled liquid culture protocol for microalgae and constructed an aerated bioreactor.
- Identified biological contaminants in microalgae culture using electron microscopy and staining techniques.
- Conducted genetic identification of contaminants via DNA extraction, PCR amplification, and sand analyzed the results of the pathogen genomic sequencing and identified the pathogen by utilizing opensource databases.
- Established cleaning and disinfection protocols for microbiological contaminants in liquid cell cultures based on the genetic identification of the biological contaminant.
- Thesis / Research Project opting for the Degree of Biotechnology Engineer/ Costa Rica
In-Vitro Plant Laboratory Assistant
PLANTECH
Cartago, Costa Rica
01.2012 - 12.2012
- Facilitated plant cell genetic transformation mediated by Agrobacterium Rhizogenes.
- Selected genetically transformed cells using selective culture medium.
- Controlled genetic transformation through PCR and Southern blot analysis.
- Monitored gene expression using SDS page and western blot techniques.
Education
Bachelor of Engineering - Biotechnology Engineer
COSTA RICA INSTITUTE OF TECHNOLOGY
Cartago, Costa Rica01.2019
BSL-3 Laboratory Research training certificate - biosafety, biosecurity, and engineering
CENTERS FOR DISEASE CONTROL AND PREVENTION/ UNIVERSITY OF IRVINE CALIFORNIA BSL-3 TRAINING PROGRAM
Atlanta, Georgia01.2024
Skills
- Medical device project management
- IVD and RUO assay manufacturing under FDA regulations
- Molecular diagnostics and SOP development expertise
- Excellent quality assurance practices
- Regulatory compliance documentation
- Milestone tracking and budget development and adherence
- Waterfall, hybrid, and agile methodology
- Advanced problem solving
- Microsoft office suite expert
- Risk management
- Proficient utilization of Excel, Microsoft Project, and SharePoint
Languages
- English
- Spanish
Personal Information
- Residency: Permanent Resident
- Title: Biotechnology Engineer
Timeline
Microbiologist III - Project Manager
CENTERS FOR DISEASES CONTROL AND PREVENTION
12.2021 - Current
Clinical Research Technician
RAYBIOTECH
06.2021 - 10.2021
Bilingual Customer Service Representative
GOLDFEIN CLAIMS MANAGEMENT
06.2020 - 04.2021
Student researcher
COSTA RICA INSTITUTE OF TECHNOLOGY
01.2019 - 07.2019
In-Vitro Plant Laboratory Assistant
PLANTECH
01.2012 - 12.2012
Bachelor of Engineering - Biotechnology Engineer
COSTA RICA INSTITUTE OF TECHNOLOGY
BSL-3 Laboratory Research training certificate - biosafety, biosecurity, and engineering
CENTERS FOR DISEASE CONTROL AND PREVENTION/ UNIVERSITY OF IRVINE CALIFORNIA BSL-3 TRAINING PROGRAM
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