Manager Project

OBJECTIVE: CLINICAL SCIENTIST/ MANAGER/DIRECTOR position in the Clinical Molecular Diagnostics/Devices Industry: In the Development of Molecular Diagnostics and/or Devices for Cancer detection, prognosis and treatment.

PROFESSIONAL PROFILE

NCA/ASCP certified Clinical Lab Specialist in Genetics & Molecular biology (Feb 2008, renewed till 2014) and licensed by the State of California (Oct. 2009, renewed till 2013). Extensive expertise in Oncology research and in assay development - FISH assays and high sensitivity molecular assays (SNPs/mutations/indels/RNA) on the Sequenom Mass Array, Luminex100 flow cytometer, ABI real time PCR/ABI sequencing platforms). Experience in IVD product development and clinical testing of molecular genetic assays under GLP/CLIA/CAP guidelines. Experience with developing and maintaining Quality Systems (QC/QA) programs. Strong supervisory, project management, organizational, operational and administrative skills.

CAREER HIGHLIGHTS - CORE COMPETENCIES:

R&D/CLINICAL: MOLECULAR ASSAY DEVELOPMENT & SUPERVISORY/ LABORATORY MANAGEMENT:

• Supervisor and Senior Scientist in the CLIA certified Molecular laboratory at NantWorks. Responsible for developing and validating high-sensitivity, molecular assays (in FFPE tumor tissue/cell-free(cf) tumor DNA in serum/plasma) to detect mutations/ SNPs/RNAs on various platforms including the Sequenom Mass Array/ABI7900 real time PCR/ABI Platforms for cancer detection/prognosis, drug response and treatment management. Manage project timelines, write protocols, technical and QC/QA SOPs, validation plans, reports. Manage laboratory and supervise technical staff, assign tasks, implement QC/QA policies and compliance with CLIA/CAP regulations and troubleshoot problems to achieve project timelines.

• As Lab Manager, set up a CLIA-certified lab to run fluorescence in-situ hybridization (FISH) assays for breast cancer (PathVysion, HER2), UroVysion bladder cancer (certified by Abbott Molecular) and cervical cancer (TERC3q26).

• Product development: Integral part of research team responsible for development of multiplexed SNP assays on Luminex Cytometer platform leading to the first IVD, a SNP-based clinical test for breast cancer risk assessment. Led transfer of multiplexed, SNP test to CLIA certified lab for clinical testing. Trained medical technologist to run clinical tests under CLIA guidelines.

• Knowledge of FDA regulated environment, Wrote the technical sections for a 510K application to the FDA for the product developed - a genetics-based SNP genotyping test for predicting breast cancer risk.

• Writing: Prepared project summaries, white paper documents for products, manuscripts and presentations at Scientific Meetings. Extensive experience writing manuscripts, poster presentations, research/project reports as well as all technical, QC/QA maintenance and procedural SOPs for CLIA Lab.

• Medical Database Administration: Contributed and involved in writing questions for medical questionnaire for conducting a case-control breast cancer study. Led, managed and successfully completed a two-month clinical prospective study designed to answer follow up questions for our large case-control breast cancer study. Compiled, analyzed data and wrote summary of findings for senior management.

• Management: R&D and Clinical Lab manager: Wrote job descriptions, interviewed and involved in recruiting new personnel. Supervised the workflow and project time-lines of 3-4 technicians in R&D as well as Clinical lab. Assumed responsibility for timely completion of projects, ensuring appropriate response to changing priorities.

• Project Management: Completed a certificate course in Biotech Project Management (Dec. 2009). As R&D manager, undertook project management tasks; including defining project milestones, timelines, and budgets in addition to applying scientific knowledge to complete projects.

CREDENTIALS

Biotech Project Management Certificate Course Online – Univ. of Washington, WA/UC San Diego Joint Program - Completed in Dec 2009

NCA/ASCP Certified Laboratory Specialist in Genetics &Molecular biology – (2008-present, renewed till 2014) and licensed by the State of California (Oct. 2009, renewed till 10/2013).

FDA Medical Devices Workshop 101, Dallas, TX. - 2007

PhD in Cellular and Molecular Pathology, University of Toronto, Canada

Master of Science in Biotechnology, Madurai Kamaraj University, Madurai, India

Bachelor of Science in Chemistry, Botany, and Zoology, Bangalore University, Bangalore, India

PROFESSIONAL EXPERIENCE

NantWorks LLC (formerly Abraxis BioScience), Costa Mesa, CA - 92626 Apr. 2010 – March 2012

Supervisor & Senior Clinical Laboratory Scientist – CLIA Molecular Lab

Responsible for (1) setting up a new CLIA-certified laboratory to run Molecular assays for cancer detection, treatment response and management, on the Sequenom Mass Array and/or ABI-real time PCR platform for melanoma and pancreatic cancer and (2) assay development and validation of new, high sensitivity molecular assays (3) writing SOPs (technical, equipment, QA/QC, lab management), validation plans, reports (4) develop and implement QA/QC programs as per CLIA/CAP guidelines and (5) Lab Management: training technician(s) to run tests, assign tasks, manage laboratory operations, equipment maintenance, QC programs.

OncoMDx LABORATORIES, Palo Alto, CA - 94303 Oct. 2009 – Feb. 2010

Consultant - Lab Manager

Responsible for setting up a new CLIA-certified laboratory to run Fluorescence in-situ hybridization (FISH) assays for cancer detection including HER2-neu in breast cancer, aneuploidy markers in bladder cancer and Telomerase (TERC3q26) assays in cervical cancer. Responsible for development and validation of new tests, training technician(s), writing technical SOPs for protocols as well as regulatory policies (CLIA) and SOPs to run these tests, supervision of laboratory.

INTERGENETICS INCORPORATED, Oklahoma City, OK - 73104 1999 - 2008

Senior Scientist

R&D as well as CLIA Lab manager: directed the workflow of four laboratory technicians, ran clinical tests under CLIA guidelines, wrote SOPs, implemented and managed QA/QC programs, lab operations, resolved and managed technical issues and timelines to meet project deadlines. Managed research projects in (1) Clinical Research leading to IVD Product Development (development of a genetics-based, breast cancer risk assessment test involving high-throughput SNP genotyping of DNA from breast cancer patients and cancer-free controls), (2) NIH-SBIR grant to discover miRNA SNPs relevant to breast cancer risk and (3) RNA Therapeutics (Prohibitn 3’UTR, a novel regulatory RNA, and its role in cell proliferation and tumor suppression in human breast cancer using in vitro/in vivo models, expression profiling, flow cytometry, fluorescence microscopy and in situ hybridization.

CALIFORNIA PACIFIC MEDICAL CENTER, San Francisco, CA – 94115. 1996-1998

Postdoctoral Fellow | Advisor: Dr. (Late) Helene Smith

Project: Functional Characterization of a Novel Gene(s) Amplified in Human Breast Cancer

Developed in-vitro models in breast cancer cell lines to study the role of these genes, especially Hs cul4A (a cullin family member) in G2/M phase cell cycle progression and apoptosis. Expressed cDNA for the gene as a fusion protein in bacteria, isolated recombinant protein for polyclonal antibody production. Utilized the antibody to examine the expression of the protein in breast cancer cell lines and human breast tumor tissue.

OKLAHOMA MEDICAL RESEARCH FOUNDATION, Oklahoma City, OK - 731**-****-****

Postdoctoral Fellow Advisor: Dr. Robert Dell’Orco

Project: The Mechanism(s) by which a Novel, Non-Coding RNA Molecule (the Prohibition Gene 3’UTR) Inhibited C1/S Phase Cell Cycle Progression in Human Breast Cancer.

Developed a technique for microdissection by adapting microinjection needles and apparatus onto a microscope for microdissection of tumor tissue on H&E stained, pathology slides of human breast tissue. The 800bp 3’UTR RNA region of prohibitin was PCR-amplified and cloned from DNA isolated from the tumor and normal cells for RNAse

mismatch assays. Identified a new single nucleotide polymorphism in the 3’UTR, abolishing the anti-proliferative activities of the 3’UTR.

UNIVERSITY OF TORONTO, Toronto, Canada 1993

Graduate Student, Advisor: Dr. D.S.R. Sarma

PhD Thesis: “Studies on the Inhibition of DNA Synthesis in Hepatocytes by Two Rat Liver Tumor Promoters: Orotic Acid and Phenobarbital.” Examined the mechanisms by which orotic acid and phenobarbital promote liver cancer in rats using both in vitro and in vivo animal models. Conducted studies on ribonucleotide reductase enzyme assays.

TECHNICAL EXPERTISE

Molecular Biology

Isolation of DNA, RNA from cell lines, fresh, frozen or FFPE tissues, Northern/Southern analysis, Nuclear run off assays, PCR, RT-PCR; RNAse mismatch assays; RNAse protection assays; Radioisotope techniques (32P, 3H and 35S), In vitro transcription, delivery of RNA into cells, In situ hybridization, Fluorescence in-situ hybridization (FISH) assays for HER2/neu (PathVysion) and aneusomy in bladder cancer (UroVysion), PCR-RFLP genotyping assays, Multiplex, allele specific fluorescence-based genotyping assays on Luminex 100TM flow cytometer platform, Mutation analysis and quantitative gene expression assays on Sequenom Mass Array and ABI7900 Real time PCR platforms.

Cell Biology

Mammalian cell culture and transfection; Rat liver perfusion for primary hepatocyte isolation and culture; Single cell cloning; Soft agar assays; Microdissection of tissue from fixed stained biopsy specimens; Immunohistochemistry;

Immunofluorescence, Immunoprecipitation, Fusion protein expression and purification, Western blotting, Flow cytometry; Cell proliferation assays; In vitro translation.

AWARDS

Pharmacia & Upjohn Award, 1996

The American Association for Cancer Research, Washington, D.C.

Selected for presentation at the Association’s Annual Meeting

Parke-Davis Award in Experimental Pathology, 1990

Honors for best paper presented

HONORS

1993 - Ontario Graduate Scholarship

1992 – Univ. of Toronto Open Doctorate Fellowship, Life Sciences Mitchell Scholarship for Cancer Research

1991 - Ontario Graduate Scholarship, Mary H. Beatty Fellowship

1990 – Univ. of Toronto Open Doctorate Fellowship

1989 – Univ. of Toronto Open Masters Fellowship, Stella Klotz Fellowship, International Differential Fee Waiver Fellowship

1988 – Univ. of Toronto Open Masters Fellowship, Edward Steven Christie Fellowship

1985-87 – Govt. of India Scholarship

AFFILIATION: Active Member of the American Association for Cancer Research, 1994 - Present.

SEMINARS

• Department of Laboratory Medicine and Pathobiology, University of Toronto. 08. 2002. Toronto, Ontario, Canada. “The Prohibitin 3’untranslated region (3’UTR) RNA, a Novel Tumor Suppressor RNA in Breast Cancer.”

• Raven Biotechnologies. 04. 2002. South San Francisco, California. “The Role of the Prohibitin 3'untranslated Region (3'UTR) RNA in Breast Cancer Cell Proliferation.”

• Department of Immunobiology and Cancer, Oklahoma Medical Research Foundation. 05.1999. Oklahoma City, Oklahoma. “Hs-cul-4a, a Member of the "Cullin" Family of Genes, as a Candidate Oncogene in Human Breast Cancer.”

• Annual Meeting of the American Association for Cancer Research. 04.1996. Minisymposium on Epidemiology and Prevention. Presented a talk entitled “Prohibitin as a Diagnostic for Breast Cancer Susceptibility and Tumor Development in Stained Slides of Tissue Sections.”

PUBLICATIONS

Diergaarde, B., Potter, J.D., Jupe, E., Manjeshwar, S., Shimasaki, C.D., Pugh, T.W., Defreese, D.C., Gramling, B.A., Evans, I. and White, E. Polymorphisms in genes involved in sex hormone metabolism, estrogen plus progestin hormone therapy use and risk of postmenopausal breast cancer. Cancer Epidemiol. Biomark. Prev. 17: 1751-1759, 2008.

Ralph DA, Zhao, L-P, Aston CE, Manjeshwar, S., Pugh, T, DeFreese DC, Gramling BA, Shimasaki CD, Jupe ER. Age-Specific Relative Risks in Steroid Hormone Pathway Gene Polymorphisms Associated with Breast Cancer. Cancer, 15;109(10): 1940-1948. 2007.

X-P. Zang, E.C. Bullen, S. Manjeshwar, E.R. Jupe, E.W. Howard and J.T. Pento. Enhanced motility of KGF-transfected breast cancer cells. Anticancer Res. 26(2A): 961-966, 2006.

Aston CE, Ralph DA, Lalo DP, S. Manjeshwar, Gramling BA, DeFreese DC, West AD, Branam DE, Thompson LF, Craft MA, Mitchell DS, Shimasaki CD, Mulvihill JJ, Jupe ER. Oligogenic combinations associated with breast cancer risk in women under 53 years of age. Hum Genet. 116(3):208-221, 2005.

S. Manjeshwar, M.R. Lerner, X-P Zang, D.E. Branam, J.T. Pento, M.M. Lane, S.A. Lightfoot, D. J. Brackett, and E.R. Jupe. Expression of prohibitin 3'untranslated region suppressor RNA alters morphology and inhibits motility of breast cancer cells. Journal of Molecular Histology 35: 639-646, 2004.

S. Manjeshwar, D.E. Branam, M.R. Lerner, D.J. Brackett and E.R. Jupe. Tumor suppression by the prohibitin gene 3’untranslated region RNA in human breast cancer. Cancer Res. 63: 5251-5256, 2003.

S. Manjeshwar, P.M. Rao, S. Rajalakshmi and D.S.R Sarma. The regulation of ribonucleotide reductase by the tumor promoter orotic acid in normal rat liver in vivo. Mol. Carcinogenesis 24: 188-196, 1999.

L-C. Chen, S. Manjeshwar, Y. Lu, D. Moore, B-M. Ljung, W-L. Kuo, S.H. Dairkee, M. Wernick, C. Collins, H.S. Smith. The Human Homolog for the C. elegans cul-4 gene is amplified and overexpressed in primary breast cancers. Cancer Res. 58: 3677-3683, 1998.

F.S. Moreno, M.R. Rossiello, S. Manjeshwar, R. Nath, , P.M. Rao, S. Rajalakshmi and D.S.R. Sarma. Effect of carotene on the expression of hydroxy-methyl-glutaryl-coenzyme A reductase in rat liver. Cancer Letts. 96(2):201-208, 1995.

Manjeshwar S, Laconi E, Sheikh A, Rao PM, Rajalakshmi S, Sarma DS. In vitro and in vivo response of hepatocytes from hepatic nodules to the mitoinhibitory effects of phenobarbital. Carcinogenesis. 15(9):1963-1968, 1994.

Backway KL, Laconi E, Manjeshwar S, Rao PM, Rajalakshmi S, Sarma DS. Resistance of hepatic nodules to orotic acid-induced accumulation of uridine nucleotides. Carcinogenesis. 15(2):403-406, 1994.

S. Manjeshwar, G. Pichiri-Coni, Coni, P., P.M. Rao, S. Rajalakshmi and D.S.R. Sarma. Ribonucleotide reductase: A possible target for orotic acid induced mitoinhibition in normal hepatocytes in primary culture. Cancer Letts. 73: 149-154, 1993.

Manjeshwar S, Laconi E, Rao PM, Rajalakshmi S, Sarma DS. Influence of orotic acid on multistage hepatocarcinogenesis in the rat: resistance of hepatocytes from nodules to the mitoinhibitory effects of orotic acid. Proc Soc Exp Biol Med. 1993 Jan;202(1):25-29, 1993.

S. Manjeshwar, P.M. Rao, S. Rajalakshmi and D.S.R. Sarma. Inhibition of DNA synthesis by phenobarbital in primary cultures of hepatocytes from normal rat liver and from hepatic nodules. Carcinogenesis 13: 2287-91, 1992

S. Manjeshwar, A. Sheikh, G. Pichri-Coni, P. Coni, P.M. Rao, S. Rajalakshmi, P. Pediaditakis, G. Michalopoulos and D.S.R. Sarma. Orotic acid, nucleotide pool imbalance and liver tumor promotion: A possible mechanism for the mitoinhibitory effects of orotic acid in isolated rat hepatocytes. Cancer Res. 52: 2078s-2081s, 1992.

SELECTED ABSTRACTS

E.R Jupe, N.S. Knowlton, T.W. Pugh, D.A. Ralph, S. Manjeshwar, D.C. Defreese, L.Blaylock, B.A. Gramling and C.D. Shimasaki. Individualized breast cancer risk prediction using the OncoVue model cancer. Proc. Amer. Assoc. Cancer Res. 49: 451, 2008.

B.F. Kimler, C.J. Fabian, J. Roweton, C.M. Zalles, T.W. Pugh, S. Manjeshwar, B.A. Gramling, D.C. Defreese, L. Blaylock and E.R. Jupe. Influence of single nucleotide polymorphisms on cytomorphology of benign breast epithelial cells acquired by random perialveolar fine needle aspiration. Proc. Amer. Assoc. Cancer Res. 49:451, 2008.

D.A. Ralph, C.E. Aston, S. Manjeshwar, D.P. Lalo, B.A. Gramling, D.C. Defreese, T.W. Pugh, C.D. Shimasaki and E.R. Jupe. Age-dependent association of common polymorphisms in conjugation enzymes genes with breast cancer risk. Proc. Amer. Assoc. Cancer Res. 47: 1264, 2006.

D.P. Lalo, D.A. Ralph, E.S. Bromley, S. Manjeshwar, T.W. Pugh, D.C. Defreese, B.A. Gramling, J.S. Seagraves, C.E. Aston, and E.R. Jupe. DNA repair polymorphisms associated with breast cancer risk in young women. Proc. Amer. Assoc. Cancer Res. 46:960, 2005.

X-P. Zang, E.C. Bullen, E.W. Howard, S. Manjeshwar, S., Jupe, E.R. and Pento, J.T. Enhanced growth of KGF-transfected human breast cancer cells in a mouse xenograft model. Breast Cancer Res. Treat. 94 (Suppl. 1): S190, 2005.

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C.E Aston, D.A Ralph, D.P Lalo, S. Manjeshwar, B.A. Gramling, D.C. DeFreese, A.D. West, D.E. Branam, L.F. Thompson, M.A. Craft, D.S. Mitchell, C.D. Shimasaki, J.J. Mulvihill and E.R. Jupe. Oligogenic combinations associated with breast cancer risk in women under 53 years of age. Human Genetics 116: 208-221, 2005.

S. Manjeshwar, M. Lerner, X-P. Zang, D. Branam, J.T. Pento, M.M. Lane, S.A. Lightfoot, D.J. Brackett and E.R. Jupe. Expression of prohibitin 3’untranslated region suppressor RNA alters morphology and inhibits motility of breast cancer cells. Proc. Amer. Assoc. Cancer Res. 45: 790, 2004.

J. Lees, S. Manjeshwar, M. Lerner, J. Barton, S. Suthers, D. Brackett, R. Postier and E. Jupe Association of prohibitin 3’UTR single nucleotide polymorphism with pancreatic head masses. Pancreatology. 2: 361, 2002.

S. Manjeshwar, D. Branam, Van De Wiele, J., M. Lerner, D. Brackett, L. Thompson and E. Jupe. The prohibitin 3’untranslated region (3’UTR), a novel regulatory RNA suppresses proliferation of MCF7 breast cancer cells. Proc. Amer. Assoc. Cancer Res. 42: 394, 2001.

E. Jupe, M. Lerner, L. Thompson, D. Branam, S. Manjeshwar, D. Farmer, B. Taylor, A. Hollingsworth and D. Brackett. Prohibitin RNA therapy in a metastatic rat mammary tumor model. Proc. Amer. Assoc. Cancer Res. 41: 353, 2000.

S. Manjeshwar, J. Cheung, B-M. Ljung, S. Dairkee and L-C. Chen. Overexpression of Hs-cul-4A protein in primary human breast cancer. Proc. Amer. Assoc. Cancer Res. 39: 209, 1998.

S. Manjeshwar, E.R. Jupe, J.K. McClung, R.T. Dell'Orco, X.T. Liu, M. Franklin, S. Lightfoot and A. Hollingsworth. Prohibitin as a diagnostic for breast cancer susceptibility and tumor development in stained slides of tissue sections. Proc. Amer. Assoc. Cancer. Res. 37: 257, 1996.

S. Manjeshwar, P.M. Rao, S. Rajalakshmi and D.S.R. Sarma. Effect of orotic acid on the regulation of ribonucleotide reductase in normal rat liver. Proc. Amer. Assoc. Cancer Res. 35: 172, 1994.

S. Manjeshwar, P.M. Rao, S. Rajalakshmi and D.S.R. Sarma Response of normal and nodular hepatocytes to the mitoinhibitory effects of phenobarbital in vitro. Proc. Amer. Assoc. Cancer Res. 34: 180, 1993.

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