Summary
Overview
Work History
Education
Skills
Publications
Timeline
Generic

Darielys Maldonado

Gaithersburg,MD

Summary

Associate Scientist analytical professional with 5 years of hands-on laboratory experience performing analytical and quantitative testing in biotech research and development environments. Experienced in executing electrophoresis-, chromatography-, and ELISA-based assays, generating and analyzing data, and maintaining accurate documentation in SOP-driven laboratories. Strong interest in supporting regulated biotech, QC, and GMP-aligned analytical operations through reliable assay execution and continuous laboratory improvement.

Overview

8
8
years of professional experience

Work History

Scientist, (Contractor, Axle Informatics)

Vaccine Production Program (VPP), NIAID, NIH
Gaithersburg, Maryland
05.2023 - Current
  • Executed routine and non-routine analytical testing to support formulation, in-process, downstream, and cell line development, generating quantitative and qualitative data for vaccine and monoclonal antibody programs.
  • Performed and optimized assays using capillary isoelectric focusing (Maurice, ICE3), gel chip electrophoresis (GXII, Fragment Analyzer), agarose gel electrophoresis, western blot, native PAGE, and HPLC to ensure accurate characterization of biomolecules.
  • Developed, qualified, and executed release residual assays (DNase, Host Cell Protein, Host Cell DNA, T7, dsRNA, endotoxin) using ELISA- and qPCR-based methods, supporting reproducible lot release and stability testing.
  • Generated, analyzed, and documented assay data for characterization and release testing, contributing to Certificates of Analysis (CoAs) and IND-enabling submissions.
  • Authored and followed GMP-aligned documentation including 15 SOPs, 5 technical memos, and 10 analytical reports, ensuring traceability, data integrity, and reproducibility.
  • Conducted risk assessments and method readiness evaluations to support assay transfer, validation, and production use.
  • Collaborated with GMP teams (VCMP) to transfer validated assays and procedures for release, stability, and qualification testing.
  • Trained junior staff on standardized molecular biology and analytical techniques, reinforcing consistent execution and data quality.
  • Maintained and qualified laboratory instrumentation to ensure consistent assay performance.

Associate Scientist

Ponce Health Sciences University
Ponce, Puerto Rico
02.2022 - 04.2023
  • Employed by the Hispanic Alliance for Clinical and Translational Research in Puerto Rico, specifically in the Technologies and Resources for Research Core Laboratories.
  • The role required collaboration with five independent Principal Investigators at the Ponce Health Sciences University.
  • Involved in PHD candidates' research design.
  • Conducted experiments involving cell culture of cancer cell lines, including Breast Cancer: MDA-MB-231, MCF-7, T47D, Lung Cancer: A549, PC-12, Prostate Cancer: PC-3, DU145, and endometriosis cell line, including EEC12Z, EEC11Z, EEC10Z, and EEC49Z.
  • Collaborated with the Puerto Rico Biobank (PRBB) with patient consent, sample collection (tissue, blood, and saliva), processing, and storage.
  • Trained undergraduate and graduate students on cell culture, transfection, western blot, agarose gel, microtomy, immunohistochemistry, immunofluorescence, Boyden, and microscope use.

Research Mentor

Pontifical Catholic University of Puerto Rico
Ponce, Puerto Rico
01.2020 - 12.2022
  • Performed personalized instruction and personal mentoring based on individual strengths and abilities as part of the Louis Stokes Alliance for Minority Participation, which increases opportunities for minority undergraduate students interested in STEM.

Research Assistant

Pontifical Catholic University of Puerto Rico
Ponce, Puerto Rico
01.2018 - 02.2022
  • Research Assistant to Dinah Ramos, PhD.
  • The role involved training undergraduate students in molecular biology techniques involving the use of the nematode Caenorhabditis elegans.
  • Presented key findings at national conferences to promote knowledge sharing.
  • Managed lab inventory effectively, reduced unnecessary expenditure on supplies.
  • Documented all procedures meticulously to ensure repeatability of experiments.
  • Prepared detailed reports summarising research findings to facilitate decision-making.
  • Assisted in grant applications, secured funding for critical projects.
  • Conducted comprehensive literature reviews for project groundwork.
  • Planned, coordinated, and executed research projects to gain insight into Autism Spectrum Disorder and Alzheimer's Disease.

Education

Master of Science - Integrated and Applied Neuroscience

Pontifical Catholic University of Puerto Rico
Ponce, PR
12.2022

Bachelor of Science - Biomedical Sciences

Pontifical Catholic University of Puerto Rico
Ponce, PR
05.2017

Skills

  • Analytical & Quantitative Assays:
    ELISA (CHO HCP, E coli HCP, HEK HCP, T7) dsRNA, qPCR (CHO HCD, E coli HCD, HEK HCD, and residual pDNA) residual DNAse, Ribogreen, UV absorbance (NanoDrop, A280, Solo VPE), LAL endotoxin testing
  • Electrophoresis & Bioanalytical Techniques:
    Capillary isoelectric focusing (cIEF; Maurice, ICE3), microfluidic capillary electrophoresis (GXII LabChip), capillary electrophoresis (Fragment Analyzer), agarose gel electrophoresis, SDS-PAGE, Western blotting, 2D gel electrophoresis
  • Chromatography & Bioseparation:
    HPLC, chromatography-based separations, protein and nucleic acid precipitation
  • Molecular Biology Techniques:
    PCR, qPCR, immunohistochemistry, immunofluorescence, microarrays, bacterial transformation, site-directed mutagenesis
  • Sample Preparation & Cell Culture:
    Protein, DNA, and RNA extraction, sample preparation for analytical assays, mammalian cell culture
  • Softwares:
    Empower, LabChip GX Reviewer, ProSize, Sapphire Gel Imaging Software, ImageJ, GraphPad Prism, SoftMax Pro (IX3), Microsoft Office Suite
  • Quality, Compliance & Documentation:
    GMP-aligned analytical testing, assay development and method execution, SOP authorship and adherence, controlled lab notebooks, analytical reports, Certificates of Analysis (CoAs), assay transfer, stability testing, validation support, BSL-2 laboratory operations
  • Training & Laboratory Operations:
    Personnel training, laboratory safety compliance, equipment maintenance and qualification, cross-functional collaboration

Publications

Enabling Process Development: Multi-Attribute Monitoring (MAM) Methodology for Glycosylated  Subunit Vaccine Production Sci Rep 15, 41198 (2025)

Asif Shajahan¹, Lisa M. Jenkins², Nathan Barefoot¹, Darielys Maldonado¹, Jeremy Wolff¹, Rong Jiang¹, Yanhong Yang¹, Sylvie R. Yang¹, Lisa Kueltzo¹, Valerie  Ficca¹, Elizabeth Scheideman¹, Ivan Loukinov¹, Dan B. Gowetski¹, Kevin Carlton¹, Jason D. Gall¹, Q. Paula Lei¹  1 Vaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health,  Gaithersburg, MD, USA  2 Laboratory of Cell Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA  

Integrating Proteomic Analysis and Machine Learning to Predict Prostate Cancer Aggressiveness Stats, MDPI, vol. 7(3), pages 1-19, August 2024

  Sheila M. Valle Cortés & Jaileene Pérez Morales & Mariely Nieves Plaza & Darielys Maldonado & Swizel M. Tevenal Baez & Marc A. Negrón Blas & Cayetana  Lazcano Etchebarne & José Feliciano & Gilberto Rui, 2024.

Timeline

Scientist, (Contractor, Axle Informatics)

Vaccine Production Program (VPP), NIAID, NIH
05.2023 - Current

Associate Scientist

Ponce Health Sciences University
02.2022 - 04.2023

Research Mentor

Pontifical Catholic University of Puerto Rico
01.2020 - 12.2022

Research Assistant

Pontifical Catholic University of Puerto Rico
01.2018 - 02.2022

Master of Science - Integrated and Applied Neuroscience

Pontifical Catholic University of Puerto Rico

Bachelor of Science - Biomedical Sciences

Pontifical Catholic University of Puerto Rico