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Quality Assurance Lab Director

Location:
Miami, FL
Posted:
December 04, 2023

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Resume:

Shamaladevi Nagarajarao

***** ** ***** ******, *****, Florida 33187

786-***-****, ad1okr@r.postjobfree.com

Highly competent in conjunction with Board certified CLIA lab director toxicology chemist, with 13 years of experience in laboratories and 8 years of experience in clinical toxicology and molecular laboratory. I can adapt to new environments, resourceful, and can successfully handle a wide range of responsibilities independently with minimal supervision. Supervisor skills including exceptional trouble shooter and detailed oriented ensuring accurate test results in a fast-paced environment. EDUCATION & CERTIFICATIONS

• Ph.D in Chemistry and Crystallography, University of Madras, Chennai, India, 2005

• Master of Science in Chemistry, University of Madras, Chennai, India.

• Bachelor of Science in Chemistry, University of Madras, Chennai,

• Board certified CLIA Lab Director, National registered clinical chemist Aug 2016 no expiration

• Lab Director- Clinical Chemistry, Department of Health, State of Florida, August 2016- 2024

• Bioanalytical Laboratory Director, New Jersey Department of Health, Jan 2018-2024

• Lab Director-Toxicology, California State department of health, February 2022- 2024

• Lab Director-Virology, New York State department of health Since 2022-2024

• ASCP accepted for Specialist in molecular biology. EXPERIENCE

Molecular Clinical Laboratory, Coral springs, FL

Laboratory supervisor, July 2022-April (Part-time) Chemistry, haematology, molecular Diagnostics and immunology

Prepare Quality control and samples for Chemistry and Immunology test analysis using Abbott Alinity Ci series.

Prepare and process the human samples for NGS test for Immunodeficiency and Diabetes panel and PGx

Validation of method assays for all tests

Responsible for quality assurance in the laboratory, as well as monitor and evaluate analytical process that produces patient results.

Perform troubleshooting of all instruments.

Managed Quality assurance (QA) and /QC records as necessary. Developed QA policies and procedures.

Molecular Stat Laboratory, Coral springs, FL

Laboratory supervisor, March 2021-May 2022, Chemistry, haematology, molecular Diagnostics and immunology

Prepare and process the human samples to detect SARS-COV2, respiratory pathogen virus in ABI quant studios 5 and 7 flex

COVID 19 testing by Panther

Validation of method assays for these testing

Responsible for quality assurance in the laboratory, as well as monitor and evaluate analytical process that produces patient results.

Perform data review and troubleshooting of instruments.

Managed Quality assurance (QA) and /QC records as necessary. Developed QA policies

Ace biomedical research, Jacksonville, FL

Technical Supervisor, 10/2020-present, Molecular diagnostics (PCR COVID-19 test) Process sample to test viral, Bacterial and fungal pathogen causing respiratory illness such as Urinary tract infection, Respiratory pathogen panel, Gastointestinal panel by molecular PCR testing by extraction of DNA/RNA.

Responsible for quality assurance in the laboratory, as well as monitor and evaluate analytical process that produces patient results.

Managed Quality assurance (QA) and /QC records as necessary. Developed QA policies and procures.

Forensic Stat laboratory, Coral springs, FL

Technical Supervisor, 10/2021-July 2022 Molecular diagnostics (PCR COVID-19 test)

Responsible for quality assurance in the laboratory, as well as monitor and evaluate analytical process that produces patient results. BTT medical institute (POL Lab) Aventura, FL

Laboratory supervisor, July 2019 - July 2020

Responsible for quality assurance in the laboratory, as well as monitor and evaluate analytical process that produces patient results.

Perform daily operations of the test menu.

Perform data review and troubleshooting of instruments.

Managed Quality assurance (QA) and /QC records as necessary. Om Diagnostics, Norwood, Massachusetts

Laboratory supervisor, Sep 2021 - Present

Responsible for quality assurance in the laboratory, as well as monitor and evaluate analytical process that produces patient results.

Perform daily operations of the test menu.

Perform data review and troubleshooting of instruments.

Managed Quality assurance (QA) and /QC records as necessary. Board certified CLIA High complexity Laboratory Director Poseidon Diagnostics, North Miami Beach,

• Molecular diagnostics, laboratory Director, March 2021 – March 2023 Oversee the entire operation of the laboratory from administration to technical section and give suggestions whenever a new discipline is executed, all instrumentation, assay kits and test menu. The lab is PCR testing for COVID-19

Microgen Health, Inc, Virginia

• Clinical Toxicology, Molecular diagnostics and Hematology laboratory Director, January 2020 – present

Oversee the entire operation of the laboratory from administration to technical section and give suggestions whenever a new discipline is executed, all instrumentation, assay kits and test menu. The lab is molecular testing for COVID-19, Respiratory virus panel(RVP), Antibiotic resistance, Next generation sequencing cardiac and pulmonary disease test. Diagnostics Labs of America, Fort Lauderdale, FL

• Clinical Toxicology, laboratory Director, February 2020 – November 2020 Oversee the entire operation of the laboratory and give suggestions if they have any question when there is a new discipline is established.

Devansh Lab Werks, Birmingham, AL

• Clinical Toxicology, Molecular diagnostics, Hematology and immunology laboratory Director, 2017 – present

Oversee the entire operation of the laboratory from administration to technical section and give suggestions whenever a new discipline is executed, all instrumentation, assay kits and test menu. The lab is molecular testing for COVID-19, Respiratory virus panel (RVP), UTI, Antibiotic resistance, PGx and wound testing.

Verify Labs, North Palm Beach, FL

• Clinical Toxicology laboratory Director, August 2017 – March 2022 Oversee the entire operation of the laboratory and give suggestions if they have any question. Consult Care pain medicine, Panama City, FL

• Clinical Toxicology laboratory Director and Technical Supervisor, March 2017 – January 2022

Responsible for quality assurance in the laboratory, as well as monitor and evaluate analytical process that produces patient results.

Perform data review and troubleshooting of instruments.

Passed COLA inspection with no citations and 100% score.

Managed Quality assurance (QA) and /QC records as necessary. Developed QA policies and procures

Twin cities Pain Clinic, Edina, MN

• Clinical Toxicology laboratory Director, August 2018 – June 2020

• Oversee the entire operation of the laboratory and give suggestions if they have any question. ATOX Labs, Cherryhill, NJ

• Clinical Toxicology laboratory Director, January 2018 – January 2020

Responsible for quality assurance in the laboratory, as well as monitor and evaluate analytical process that produces patient results.

Perform data review and troubleshooting of instruments.

Coordination with Sales Director to maintain or exceed client expectations Three rivers Pain management, Uniontown, Pennsylvania Clinical Toxicology laboratory Director, January 2017-January 2018 Responsible for quality assurance in the laboratory, as well as monitor and evaluate analytical process that produces patient results

Miami Dade community college (Medical Campus) and Everglades university, FL Adjunct Faculty, April 2019 - present

Teaching associate degree students, urinalysis, Clinical instrumentation, haematology and immunology

Zentech Laboratories/SW labs, Fort Lauderdale, FL

• LC/MS Certifying scientist/ Supervisor, October 2015 – October 2018

Provide day to day supervision of personnel performing testing.

Monitor and Review Quality Control data in accordance to COLA and CLIA regulations.

Perform data review and troubleshooting on Shimadzu 8040 and 8050 LC/MS.

Troubleshoot and operated Olympus chemistry analyzers (AU 400, AU480),

Expanded LC/MS testing menu from 30 analytes to 79 analytes while improving efficiency and accuracy.

Implemented in-house blood testing using Olympus analyzer, DXI 600 and Act5.

Implemented an enhanced software changeover impacting LIS, billing, and result reporting.

Provide technical support and education for new clients, marketers and sales team. National laboratory Group, Fort Lauderdale, FL

• LC/MS Certifying scientist/ Supervisor, April 2016 – December 2017

• Provide day to day supervision of personnel performing testing.

• Monitor and Review Quality Control data in accordance to COLA and CLIA regulations.

• Perform data review and troubleshooting on Shimadzu 8040 and 8050 LC/MS. Imperial Diagnostics Fort Lauderdale, FL

• LC/MS Certifying scientist/ Supervisor, June 2016 – December 2017

Provide day to day supervision of personnel performing testing.

Monitor and Review Quality Control data in accordance to COLA and CLIA regulations.

Perform data review and troubleshooting on Shimadzu 8040 and 8050 LC/MS. Oracle Diagnostics, Fort Lauderdale, FL

• LC/MS Certifying scientist/ Supervisor, Nov 2016 – December 2017

• Provide day to day supervision of personnel performing testing.

• Monitor and Review Quality Control data in accordance to COLA and CLIA regulations.

• Perform data review and troubleshooting on Shimadzu 8040 and 8050 LC/MS. LCM diagnostic lab Fort Lauderdale, FL

• LC/MS Certifying scientist/ Supervisor, Dec 2016 – December 2017

Provide day to day supervision of personnel performing testing.

Monitor and Review Quality Control data in accordance to COLA and CLIA regulations.

Perform data review and troubleshooting on Shimadzu 8040 and 8050 LC/MS. QDS Toxicology, Fort Lauderdale, FL

• LC/MS Certifying scientist/ Supervisor, Dec 2016 – December 2017

Provide day to day supervision of personnel performing testing.

Monitor and Review Quality Control data in accordance to COLA and CLIA regulations.

Perform data review and troubleshooting on Shimadzu 8040 and 8050 LC/MS. University of Miami School of Medicine/Miami VA

• Scientist, July 2010-July 2015

• Project: Identification (isolation, characterization and structural studies) of novel chemo-preventive agents against prostate, breast and pancreatic cancers from natural products and investigate the molecular mechanism(s) and toxicity studies by which these potential agents prevent cancer progression. Opened a new field of research related to the combinatorial drug treatment of potential agents from natural products with existing chemotherapeutic drugs.

• Responsibilities: Responsible for design, implementation and management of multiple research projects for both NIH and VA grants; Writing grants; Review grant proposals and manuscript submissions; Concurrently advise two junior postdoctoral fellows; Supervise and direct the research projects of graduate and medical students; Train and supervise technical and research staffs; Scientific presentations judging in national seminars/meetings (Neuroscience/Cancer 2011-present). University of Miami School of Medicine

• Postdoctoral Research Fellow, June 2006-June 2010

• Project: Identified a novel antitumor compound "Ericifolin" from a natural product "Allspice" that silences Androgen Receptor in prostate cancer thereby prevented prostate cancer growth. Additionally, shrinkage of experimental benign prostatic hyperplasia and reduction of prostatic cell volume was identified when prostate cancer cells were treated with gastrin-releasing peptide antagonists. This work was done in collaboration with Nobel Laureate Dr Andrew Schally (see publications below).

• Proven experience in validation of analytical methods in support of product development, assay development/validation/quantification and use in preclinical and clinical research in the setting of toxicity assays.

Department of Biophysics and Crystallography, University of Madras Title: Structural studies in Trypsin and peptides and molecular modeling of Mycobacterium. Doctoral Research, 2000-2005

Dissertation chair: Vasantha Pattabi, Ph.D.

TECHNICAL SKILLS

Molecular biology: DNA recombination, plasmid/retroviral plasmid construction, gene sequencing stable/transient transfection, rescue targeted gene expression, Real time-PCR, qPCR situ hybridization, DNA and RNA isolation, Southern and Northern transfer, next generation sequencing. Medicinal chemistry: Practical experience on LC-MS spectrometry, Shimazdu, 8040 and 8050 series Triple Quadrupole LC-MS, Agilent 6460C Mass hunter, ABSciex and Thermofischer Data acquisition, processing and interpretation of acquired data from human specimens, troubleshooting, and optimizing cutting-edge bioanalytical (LC-MS) methods and instrumentations and method validation and development and have experience in leading a lab through a COLA inspection. Toxicological studies: LC-MS confirmation testing on drug of abuse substances, screening drug of abuse analytes using chemistry analyzer. Ammonia neurotoxicity in hepatic encephalopathy, cancer and immune toxicology, and heavy metal poisoning.

Cell biology: Mammalian cell culture, rescue targeted gene expression, primary cell culture, cell cytotoxicity study, angiogenesis in vitro/in vivo, cell adhesion and chemotactic migration assay by 3D assay, luciferase reporter assay, apoptosis and differentiation assays, immunofluorescent double/triple staining, cell sorting by FACS, protein kinase activity assay, Enzyme assays, Mitochondrial properties such as ROS and mitochondrial membrane potential.

Microscopy: Light microscopy, fluorescent/laser confocal microscopy, cell size determination by confocal microscopy.

Virology: Preparation and infection of Epstein-Barr virus and retrovirus. Immunology: Primary T cell isolation, culture and transfection, luciferase assay, ChIP assay, EMSA, ELISA, immunoprecipitation, Western blotting, immunocytochemistry, immunohistochemistry, flow cytometry.

Tumor biology: Orthotopic and subcutaneous tumor generation in mouse model, oral gavage an IP injection of cytotoxic compounds to mouse, survival surgery in mouse model. Generation of transgenic mouse model, tumor metastasis (intracardiac injections, tail vein injection) animal x-ray radiography, Genotyping.

Pathology: Histological and pathological diagnosis, techniques for sample/section preparation and HE stains, immunohistological double/triple staining. Computer skills: Statistical package with working knowledge: Prism, Sigma Plot, Sigma stat. General packages: Microsoft office, Adode photoshop, Corel draw, C-language Genetic/proteomic analysis software: BLAST, FASTA, RasMol, PROSITE, DPM, DSC, GOR4, SOPM, PHD/PREDATOR.

Regulatory skills. I have knowledge on COLA, CLIA and CAP regulations, and on FDA regulatory requirements for clinical research studies.

PUBLICATIONS

Shamaladevi, N, Jayakumar, AR, Sujatha R, Paul V and Subramanian EH (2002). Evidence that nitric oxide production increases gamma aminobutyric acid permeability of blood-brain barrier. Brain Research Bulletin, 57: 321-326 (Impact factor, 2.97). Damodharan L, Shamaladevi N, Pattabhi V, Behera, M and Kotha S. (2002). Ethyl 6-Acetylamino- 6-7-dihydro-5H-dibenzo [a,c] cycloheptene-6-carboxylate. Acta Crystallographica C, 58, o266-7

(Impact factor, 0.492).

Shamaladevi, N and V. Pattabhi. (2004). Lup-1, 20(29)-dien-3-one, a triterpenoid from Agyneia bacciformis A. Juss. Acta Crystallographica E, 60: o1092-o1093 (Impact factor, 0.347). Ibrahim, B.S, Shamaladevi N and V. Pattabhi. (2004). Secondary binding site of trypsin: revealed by crystal structure of trypsin-peptide complex. J Biomol Struct Dyn, 22: 635-642 (Impact factor, 4.986).

Shamaladevi N and V. Pattabhi. (2005). Secondary binding site of trypsin: revealed by crystal structure of trypsin-peptide complex. J Biomol Struct Dyn, 22: 635- 642 (Impact factor, 4.986). Shamaladevi N, Lyn DA, Escudero DO, Lokeshwar BL. (2009). CXC receptor-1 silencing inhibits androgen-independent prostate cancer. Cancer Research, 69: 8265-74 (Impact factor, 8.65). Subbarayan PR, Sarkar M, Shamaladevi N, Philip S, Kumar P, Altman N, Reis I, Ahmed M, Ardalan B, Lokeshwar BL (2012). Achyranthes aspera (Apamarg) leaf extract inhibits human pancreatic tumor growth in athymic mice by apoptosis. J Ethnopharmacol, 142: 523 (Impact factor, 2.755).

Anaid Beneitz, Travis J Yates, Shamaladevi N, Vinata B Lokeshwar (2013). Dietary supplement Hymecromone and sorafenib: a novel combination for the control of renal cell carcinoma. Journal of urology. 90: 285-90 (Impact factor: 4.2)

Rick, F.G, Abi-Chaker, Szalontay, L Perez, R, Jaszberenyi, M, Jayakumar, AR, Shamaladevi N, Szepeshazi, K,Vidaurre, I, Halmos, G. Block, N.L, Schally A.V (2013). Shrinkage of experimental benign prostatic hyperplasia and reduction of prostatic cell volume by a gastrin-releasing peptide antagonist. Proceedings of the National Academy of Sciences (PNAS),110; 2617-22 (Impact Factor, 10.6).

Shamaladevi, N, Dominic A. Lyn, Khaled A. Shaaban, Lei Zhang, Susana Villate, Jürgen Rohr & Lokeshwar BL (2013). Ericifolin: A Novel Antitumor Compound from Allspice that Silences Androgen Receptor in Prostate Cancer. Carcinogenesis, 34: 1822-32 (Impact Factor, 5.70). Jayakumar, A.R. Tong, X.Y, Curtis, K.M., Ruiz-Cordero, R, Shamaladevi, N, Abusamel, M, Gaidosh, G, Johnstone, J, Ramarao, K.V, Norenberg, M.D (2014). Decreased astrocytic thrombospondin-1 secretion after chronic ammonia treatment reduces the level of synaptic proteins: In vitro and in vivo studies. Journal of Neurochemistry doi: 10.1111/jnc.12810. Comments in: Albrecht J, Zielińska M. Deficit of astroglia-derived thrombospondin-1 and loss of synaptic proteins in hepatic encephalopathy: do ammonia-overexposed astrocytes derange the synaptic hardware? J Neurochem. 2014 Aug 8. doi: 10.1111/jnc.12823. Astrocytic TSP-1 localization in adult rat brain (Cover page, J Neurochem. Vol 131, November issue, 2014) Jayakumar AR, Valdes V, Tong XY, Shamaladevi N, Gonzalez W and Norenberg MD (2014). Sulphonylurea Receptor-1 contributes to the astrocyte swelling and brain edema in acute liver failure. Trans. Stroke Res., 5: 28-37 (Impact Factor, 2.00). Lei Zhang, Shamaladevi N, Lokeshwar BL (2015). Polyphenol-rich extract of Pimenta dioica berries (Allspice) Kills Breast Cancer Cells by Autophagy and Delays Growth of Triple Negative Breast Cancer in Athymic Mice. Oncotarget Apr 14.

Jayakumar AR, Tong XY, Shamaladevi N, Barcelona S, Gaidosh G, Agarwal A, Norenberg MD

(2016) Defective synthesis and release of astrocytic Thombospondin-1 mediates the neuronal TDP- 43 Proteinopathy resulting in defects in neuronal integrity associated with chronic traumatic encephalopathy: In vitro studies. J Neurochem. Oct 13. Doi: 10.1111/jnc.13867. Shamaladevi N, Araki S, Lyn DA, Ayyathurai R, Gao J, Lokeshwar VB, Navarrete H, Lokeshwar BL. The andean anticancer herbal product BIRM causes destabilization of androgen receptor and induces caspase-8 mediated-apoptosis in prostate cancer. Oncotarget. 2016 Oct 1. doi: [Epub ahead of print]. 0.18632/oncotarget.12393.

Jayakumar AR, Curtis KM, Panickar KS, Shamaladevi N, Norenberg MD. Decreased STAT3 Phosphorylation Mediates Cell Swelling in Ammonia-Treated Astrocyte Cultures. Biology

(Basel). 2016 Dec 2;5(4). pii: E48.

Jayakumar AR, Taherian M, Panickar KS, Shamaladevi N, Rodriguez ME, Price BG, Norenberg MD. Differential Response of Neural Cells to Trauma-Induced Swelling In Vitro. Neurochem Res. 2018 Feb;43(2):397-406.

Andre R Jordan, Jiaojiao Wang, Travis J Yates, Sarrah L Hasanali, Soum D. Lokeshwar, Daley Morera, Nagarajarao Shamaladevi, Charles S. Li, Zachary Klaassen, Martha K Terris, Mark S. Soloway, Muthusamy Thangaraju, and Vinata B. Lokeshwar (2020). Molecular Targeting of Renal Cell Carcinoma by an Oral Combination, Oncogenesis. Mehran Taherian, Michael D Norenberg, Kiran S Panickar, Nagarajarao Shamaladevi, Anis Ahmad, Purbasha Rahman, Arumugam R Jayakumar, Additive Effect of Resveratrol on Astrocyte Swelling Post-exposure to Ammonia, Ischemia and Trauma In Vitro, Neurochem Res 2020 May;45(5):1156-1167.

Michael Paidas, Sampath Natarajan, Emma A Schindler, Daniela S Cosio, Chima Obianuju Ndubizu, Shamaladevi Nagarajarao, Jaclyn Kwal, Suset Rodriguez, Anis Ahmad, Norma Sue Kenyon, Arumugam R Jayakumar (2022) Mechanism of Multi-Organ Injury in Experimental COVID-19 and Its Inhibition by a Small Molecule Peptide. Frontiers in Pharmacology, section Pharmacoepidemiology.

Research articles submitted for publication and in preparation: Shamaladevi N, Dominic AL, Susana V, Lei Zhang, Joem Serrano and Lokeshwar BL (2022). Prostate cancer progression was prevented by BIRM in TRAMP model. Cancer Research (Impact factor, 8.65).

Jayakumar AR, Shamaladevi N and Norenberg MD (2022). Role of microglia in the development of chronic traumatic encephalopathy: In vitro and in vivo studies. Nature Neuroscience.



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