Usha Gundimeda
San Gabriel,CA
Summary
Highly self-motivated, can independently optimize in-vitro assays( biochemical, High-Throughput cell-based assays for Screening of new drug therapeutics development for the cure of diseases. Expert in IHC, Immunofluorescence. DNA & RNA isolation using kits in tissues, blood, and cells. Proficient in ISH by preparing reagents following GLP methods. Worked in process development using analytical methods like ELISA and dd PCR. Design, verify, and validate assay development in a cGMP matrix environment. Familiar with regulatory compliances like FDA, GLP, and GCP of clinical trials. Data Analysis, submit data in LIMS, interpret, CAPA, SOPs, and protocols for approval. Published 41 well-cited papers as an author and co-author in various scientific journals.
Diligent Scientist with a proven track record of leading innovative research projects and contributing to significant scientific advancements. Recognized for developing efficient methodologies that enhance experimental outcomes. Demonstrated expertise in data analysis and molecular biology techniques.
Overview
26
26
years of professional experience
1
1
Certification
Work History
Senior Scientist
Chromologic LLC
12.2023 - 06.2024
- Verification and validation of different cytokines for ELISA assays in Lyopholized samples
- Worked with engineers to test clinical malarial samples for the development of rapid diagnostics and FDA approval
- Interacted with Chemical Engineers for developing handheld CRISPR based rapid diagnostics for the detection of malaria
- Optimed conditions for rapid counting and growing of Jurkat cells in a handheld bioreactor
- Contibuted both Clinical and biological samples results and summary for the different grant fundimg agencies along with the team
Senior Scientist Applied Research (Scientist II)
Abbott Laboratories
02.2021 - 10.2022
- Conduct technical tasks with expertise in various types of assay development & optimization with antibodies, antigens, proteins, conjugates, and chemicals and contribute to projects
- Design input, output, Design Transfer, verification & validation methods of HEIA and SEFRIA for urine and oral fluid as per the suggestions of the team
- Knowledge of 21CFR 820.30 and prepare justification(s) for gap assessment of FDA
- Experience with homogeneous enzyme immunoassay by using automated chemistry AU 480 analyzer and by using microplate readers.
- Prepare protocols for design transfer and product deviation reports for customer queries based on the suggestions received from the team
- Attended a two-day workshop given by Abbott on how to prepare Human Factors Engineering (HFE) for new medical product development of Rapid Diagnostics
- Testing of antibodies by measuring the aggregation and degradation by using SDS-PAGE
- Basic functionality test (BFT) to measure binding of the Ab to a drug G6PDH enzyme conjugate
- Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) as well as Local Institutional Review Board (IRB) regulatory submission for the medical device approval
Research Scientist (Contractor)
Kite Pharma, A Gilead Company
09.2019 - 02.2021
- Process development/optimization – Can perform overall product characterization under cGMP follows SISPQ (Safety, Identity, Strength/Potency, Purity, and Quality) bioanalytical testing
- Measuring impurities in clinical samples by using different ELISA methods (SOPs & TMs) by using Spectra Max platforms and analysing data and interpretation
- Routinely tested for vector copy number (VCN) by using dd PCR, QPCR, and RT-qPCR
- These tasks included competencies in infectivity assays, DNA and RNA extraction by following SOPs
- Ability to work well with global teams, including time-zone flexibility
- Data analysis and interpretation of results reported by using LIMS (Bio-Via)
- Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) and cGMP certifications
Senior Research Scientist
Quantum Screening
02.2019 - 06.2019
- Identified and developed Sandwich ELISA methods by using oral fluid for validation of biomarkers in the early detection of oral cancer
- Optimized and tuned protocols for validation of cancer biomarkers and analysed data by using Graph Pad Prism 7
- Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) as well as Local Institutional Review Board (IRB) regulatory submission for the medical device approval
- Searched for vendors for a medical product development, submitted IRB protocols, assisted in submitting scientific data for patents and FDA
- Maintaining clinical data for human saliva samples and HIPPA certification obtained
Res. Associate/ Res. Lab Specialist/ Senior Res. Associate
USC Keck School Medicine
02.2005 - 10.2018
- Studies conducted on ApoE4 aggregation, hypo lipidation, and endosomes in Alzheimer’s disease pathology in cellular, animal and human models
- Lab certification, Institutional IRB protocol submission, collecting PIs CVs for collaboration for submitting grant proposals to PI
- Employed double and triple immunofluorescence, and colocalization analytical methods to determine the subcellular trafficking of proteins
- Evaluated the effect of Apo E isoforms on ABCA1 colocalization and expression in HeLa cells
- Standardized quantification of Apo E lipo-forms in the CSF mouse brain and astrocytes SFM by native gel electrophoresis
- Published the role of Neuropilin-1/Semaphorin-3A signalling in the functional and morphological integrity of the cochlea
Post-doctoral Fellow
Beckman Research Institute
09.2003 - 11.2004
- Investigated role of CEA in breast cancer using siRNA shRNA
- Trained student researchers in cell and molecular biology techniques
- Assisted the PI with grant proposals for secure funding to maintain lab
Senior Research Associate and Lab Manager
USC Keck School of Medicine
11.2000 - 07.2003
- Developed multi-well rapid screening and assay of various protein kinases and protein phosphatases
- (Published in Analytical Biochemistry as a co-author)
- Optimized multiplexed viability, cytotoxicity, and apoptosis assays for cell-based screening
- Studied the receptor-mediated signal transduction in neuroprotection and neurodegeneration
- Quantitated the NMDA receptor subunits and its phosphorylation
- Utilized methodologies for culturing primary hippocampal neutrospheres and oxygen glucose deprivation model for stroke
- Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) as well as USC Institutional Review Board (IRB) regulatory submission for research funding to PIs
Research Scientist, Dept. of Toxicology and Pharmacology
National Institute of Nutrition (ICMR)
04.1998 - 10.2000
- Worked on measurement of Dietary intake of nitrates and nitrosamines in Indian population
- Identified the foods which are contributing to high incidence of oral and gastric cancers
Education
Ph.D. - Cell Biology and Toxicology
Osmania University
NIH Fogarty Visiting Fellow - Drug Disposition and metabolism of Citral in Fischer 344 rats
National Institute of Environmental Health
Research Triangle Park, NCSkills
- SharePoint
- Smart Sheets
- Teams
- ELISA
- Characterization techniques
- UV
- Fluorescence
- AUC
- LIMS
- SOPs
- Laboratory protocols
- Cell culture
- Potency Assays
- Cell-based bioassays
- Immune assays
- DNA transfections
- RNA transfections
- RNAi
- Stable cell line development
- High throughput methodologies
- Histopathology
- Histochemistry
- IHC Immunofluorescence
- ISH
- Analytical methods
- SDS-PAGE
- Native-PAGE
- Western immune-blots
- Immunoprecipitation
- Receptor-binding biochemical assays
- Cell and gene therapy
- Molecular techniques
- DNA isolation
- RNA isolation
- Genomic PCR
- Conventional PCR
- Quantitative PCR
- Dd PCR
- GxP
- PowerPoint presentation
- Multiplex ELISA
- Assays
- Graph pad Prism
- Statistical Data Analysis
- IRB protocol submission
- Lab Certification
- CGMP
- Regulatory compliance
- FDA submissions
- Gap Assessment
- HIPAA certification
- Good Laboratory Practice
- FDA Good Clinical Practice
- Biochemistry
- Luminiscence analysis
- Fluorimetric analysis
- Mammalian cell culture
- Western blot
- Laboratory experience
- Research Literature
- Cell-based assays
- Molecular biology
- Transfections
- Project management
Certification
- Clinical Research Coordinator (CRC), Certified in IRB, SOPs, GCP, GLP, cGMP, and GDP for clinical trials & medical device development.
- HIPAA Compliance, USC
Publications
41, Well cited research papers published both as an author and co-author in the areas of Cancer and Neurobiology., https://www.ncbi.nlm.nih.gov/pmc/?term=Gundimeda+U
Timeline
Senior Scientist
Chromologic LLC
12.2023 - 06.2024
Senior Scientist Applied Research (Scientist II)
Abbott Laboratories
02.2021 - 10.2022
Research Scientist (Contractor)
Kite Pharma, A Gilead Company
09.2019 - 02.2021
Senior Research Scientist
Quantum Screening
02.2019 - 06.2019
Res. Associate/ Res. Lab Specialist/ Senior Res. Associate
USC Keck School Medicine
02.2005 - 10.2018
Post-doctoral Fellow
Beckman Research Institute
09.2003 - 11.2004
Senior Research Associate and Lab Manager
USC Keck School of Medicine
11.2000 - 07.2003
Research Scientist, Dept. of Toxicology and Pharmacology
National Institute of Nutrition (ICMR)
04.1998 - 10.2000
NIH Fogarty Visiting Fellow - Drug Disposition and metabolism of Citral in Fischer 344 rats
National Institute of Environmental Health
Ph.D. - Cell Biology and Toxicology
Osmania University
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