Astha Malik
Cincinnati
Summary
Scientific Development Leader with 9+ years of experience driving assay development, validation strategy, and scientific oversight across regulated clinical laboratories and translational research environments. Expert in flow cytometry, cell‑based functional assays, and molecular platforms, with deep experience authoring regulatory‑grade documentation (CLIA, CAP, FDA). Known for scientific ownership, cross‑functional leadership, and the ability to translate complex data into actionable decisions for clinical trials and therapeutic programs.
Overview
11
11
years of professional experience
Work History
Development Scientist
CTI Clinical Trials & Consulting
10.2024 - Current
- Lead scientific owner for flow cytometry and cell‑based assay development in a CAP/CLIA‑regulated clinical laboratory.
- Lead design, optimization, and validation of flow cytometry and functional assays supporting clinical trials and translational studies.
- Collaborate with Laboratory Directors to define assay acceptance criteria, validation strategy, and quality requirements.
- Authored and maintained validation plans, reports, SOPs, training modules, and regulatory-ready documentation to ensure compliance and support assay development.
- Perform in‑depth data analysis and interpretation to support assay development and clinical testing.
- Trained laboratory staff on new assays, ensuring competency and adherence to validated workflows to enhance assay reliability.
- Oversee LIMS test builds and workflow integration for cellular and flow cytometry assays.
- Support FDA, CLIA, and CAP inspections through preparation of scientific documentation and participation in audits.
- Established and monitored Quality Management Programs for new assays to ensure regulatory compliance and quality assurance.
Staff Scientist
Cincinnati Children’s Hospital Medical Center
01.2023 - 01.2024
- Pioneered CRISPR/Cas9 gene‑editing validation in patient‑derived iPSCs, establishing a platform for functional genomics.
- Validated immunological assays (flow cytometry, ELISA, cytokine profiling) to evaluate drug efficacy and elucidate mechanism of action.
- Directed in vivo and in vitro studies, developing disease models and designing studies to support data interpretation.
Associate Staff Scientist
Cincinnati Children’s Hospital Medical Center
01.2020 - 01.2023
- Led immunology research programs on autoimmune liver disease, utilizing transgenic animal models to advance understanding of disease mechanisms.
- Developed and validated immunological assays (flow cytometry, ELISA, cytokine profiling) to support therapeutic discovery.
- Collaborated with molecular biology and bioinformatics teams to integrate mechanistic insights with translational findings, enhancing research impact.
- Mentored junior scientists and research associates, enhancing team capability and ensuring rigorous scientific practices.
- Presented research findings to internal leadership, external collaborators, and regulatory bodies.
Clinical Research Associate
Cincinnati Children’s Hospital Medical Center
01.2018 - 01.2020
- Utilized murine models (ovalbumin, HDM) to assess lung inflammation and injury, advancing understanding of disease mechanisms.
- Investigated eosinophilic disorders in pediatric patients, yielding mechanistic insights that informed therapeutic strategies.
- Executed molecular biology techniques including ChIP‑seq, ATAC‑seq, Western blotting, ELISPOT, and ELISA.
- Developed and optimized lentiviral transfection workflows for primary cell cultures, enhancing experimental reliability.
Research Fellow
Cincinnati Children’s Hospital Medical Center
01.2015 - 01.2018
- Investigated transcriptional regulation of neurogenesis using molecular and genomic approaches (ChIP‑seq, ATAC‑seq, qPCR).
- Designed mechanistic studies to elucidate transcription factor–DNA interactions and their role in neural differentiation pathways.
- Led IACUC and IBC submissions, ensuring compliance with animal welfare and biosafety regulations to facilitate research integrity.
- Maintained GDP-compliant, audit-ready documentation for preclinical GLP studies, supporting regulatory adherence and research credibility.
Education
Ph.D. - Biology
Bowling Green State University
Bowling Green, OH08-2015
M.Tech - Biotechnology
Amity University
B.Tech - Biotechnology
Amity University
Skills
- Flow Cytometry
- Assay Development & Validation
- CLIA/CAP Compliance
- Scientific Leadership
- Cross‑Functional Collaboration
- Data Interpretation
- LIMS Integration
- Sponsor‑Facing Scientific Support
- Quality Systems
- PK/PD & Statistics
- Immunology
- Autoimmune Disease
- Molecular Biology
- Neuroscience
- Circadian Biology
- Inflammatory Disorders
Affiliations
- AASLD
- Sigma Xi
- AAAAI
Awards
- AASLD Autoimmune Liver Diseases Exploratory Research Award (PI, $50,000)
- AASLD Early Career Investigator Award
- AASLD Pediatric Research Award
- EASL Young Investigator Award
- Outstanding Teaching Assistant Award
- Leadership Award, Amity University
Publications
Astha Malik - Google Scholar
Languages
- Hindi
- English
- Hindi
Therapeutic And Technical Expertise
- Immunology
- Autoimmune Disease
- Molecular Biology
- Neuroscience
- Circadian Biology
- Inflammatory Disorders
Timeline
Development Scientist
CTI Clinical Trials & Consulting
10.2024 - Current
Staff Scientist
Cincinnati Children’s Hospital Medical Center
01.2023 - 01.2024
Associate Staff Scientist
Cincinnati Children’s Hospital Medical Center
01.2020 - 01.2023
Clinical Research Associate
Cincinnati Children’s Hospital Medical Center
01.2018 - 01.2020
Research Fellow
Cincinnati Children’s Hospital Medical Center
01.2015 - 01.2018
Ph.D. - Biology
Bowling Green State University
M.Tech - Biotechnology
Amity University
B.Tech - Biotechnology
Amity University