Ludmila M. Flores

*

Ludmila M. Flores, ALM, MBA, QA

Cell phone: 617-***-****

ac5q0x@r.postjobfree.com

https://www.linkedin.com/in/ludmila-m-flores-alm-mba-qa-b50b19121 QUALIFICATIONS

• 17 Years of experience in project management, lab management, operation management, clinical trial monitoring, and emergency management

• 17 Years of experience in developing, implementing, and managing projects in basic, translational, and clinical research

• 1 Years of experience in implementing and managing safety standards (Environmental safety, Occupational safety, Animal safety, Biosafety) and compliance with JCAHO, OSHA, HIPAA, etc., and hospital guidelines

• 10 Years of experience managing projects with pharmaceutical companies

• 15 Years of experience as patient advocate/community outreach (volunteer)

• 5 Years of experience in policy development and analysis

• Computer skills: Outlook, Windows, Prism, EverNote, MetaMorph, Fiji ImageJ, Quick Book, SPSS, LIMS.

• Language: English and Czech (fluent); Spanish and Russian (Basic) WORK HISTORY

• Brigham & Women Hospital, Boston, MA – Sr. Research Lab Manager/Safety Officer 2016- 2018

• Brigham & Women Hospital, Boston, MA – Research Project Manager 2015-2016

• Dana-Farber Cancer Institute, Boston, MA – Research Lab Manager/Safety Officer 2000–2005 and 2007–2014

• St. Elizabeth's Medical Center, Brighton, MA – Senior Research Technician/Biosafety Officer 2005-2006

• Boston Children’s Hospital, Boston, MA – Research Consultant 2002-2005 EDUCATION

• Doctorate in Public Policy and Administration (PhD), Walden University, Minneapolis, MN expected in 2019

• Master of Business Administration (MBA), Capella University (ACBSP), Minneapolis, MN

• Master of Liberal Arts (ALM) in Life Sciences, Biotechnology, Harvard University of Extensive Studies, Cambridge, MA

CERTIFICATES

• Quality Assurance & Regulatory Affairs Program Certificate/Internship (QA) In Pharmaceutical Industry, the International Conference on Harmonization (ICH), Good Clinical, Laboratory, Manufacturing Practice (GCP, GLP, GMP) Guidelines. Kriger International Research & Training Center

• National Institute of Health Certification: Protecting Human Research Participants Ludmila M. Flores

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• Collaborative Institutional Training Initiative (CITI)

• Introduction to Hazard Mitigation (IS-00393.a). FEMA U.S. Department of Homeland Security

COMMITTEE

• Scientific Advisor. Brigham and Women’s Institutional Animal care and Use Committee

(BWH IACUC)

RELEVANT SKILLS

Management

• Direct several complex projects simultaneously by utilizing the tools, techniques and methodology of professional project management and budgeting across multifunctional teams.

• Serve as a single point of contact for cross-functional program information (content and quality)

• Initiate, expand, and implement new projects for effective program development using standard principles of operations management and business/marketing policy and strategy

(Toyota Way Lean Leadership, TPS, Six Sigma).

• Identify key deliverables for each function and their inter-dependencies

• Conduct risk management, contingency and scenario planning using a variety of project management tools. Perform necessary risk management to minimize project risks

• Manage the relationship with clients and all stakeholders. Develop strong partnerships with external business partners and strategic alliances.

• Identify, analyze, and implement new technology and techniques

• Manage project implementation, monitoring, evaluation, preparation of progress reports to

• donors and stakeholders, and communication to donors and stakeholders.

• Create SWOT analysis, business forecasting, financial assessment, and budgeting.

• Manage lab and project operation

• Assure progress monitoring of a multi-level prevention system, and data-based decision- making system.

• Provide staff events management, financial and administration support.

• Provide training to new members, team operation needs, establish new technology evaluation and standard operation protocols (SOPs); build high-preforming cross-functional teams Quality Assurance

• Prepare and conduct audits in support of GCP, GLP and GMP as directed.

• Prepare and coordinate IACUC, IRB, HIPAA, FDA, IND, CLIA, etc. materials, correspondence, and other regulatory documents. Assure compliance.

• Manage to appropriately resolve compliance issues, resolve conflicts.

• Communicate audit results to management by means off written audit reports. Manage post- audit activities and pursuing on any necessary corrective and preventive actions

• Train staff with GLP, ISO 9000, role of QA, regulatory audits, etc.

• Ensured to adhere to Good Laboratory Practice (GLP) regulations and guidelines, and ISO 9000 requirements

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Clinical Trials

• Prepare and coordinate consent forms

• Prepare and conduct study initiation, closeout, and monitoring visits at clinical investigative sites

• Maintain site files, trial master files and study documentation

• Prepare and coordinate IRB, HIPAA, OHRS, and other materials, correspondence, and other regulatory documents.

Research

• In vivo studies (mice and rats): maintenance, injections (I.P., subcutaneous, oral, tail), tumor implantation and tumor collection, blood collection, surgery, liver and kidney regeneration (splenectomy, adrenalectomy, nephrectomy, thymectomy, jugular vein and carotid artery catheterization), autopsy, heart/vessel perfusion and angiography.

• Radiation: mice and cells; SSARP Targeted radiation and in vivo imaging.

• In vivo studies (zebra fish): maintaining multiple genetic fish lines, chemical screen, calcium transient mapping, voltage mapping.

• Histology/Pathology: IHC and IF techniques on fresh, frozen and paraffin sections, histological and pathological analysis of IHC and IF stained tissues, computer imaging

• Chick assays: preparation of the chorioallantoic membrane (CAM),

• In vitro studies: propagation and maintenance, fixation, FACS analysis, IHC and IF techniques, functional assays: MTT, PicoGreen, BrdU, ADCC, ELISA, invasion, adhesion, clonogenic assays, single-cell cloning, 2D and 3D culture.

• Circulating Tumor Cells: isolation, FISH, IHC, IF etc.

• Molecular techniques: Western Blot, genomic DNA, RNA, miRNA and exosomal miRNA isolation; PCR, QPCR, and RT-PCR techniques, genotyping, Nanostring technology

• Flow cytometry, single and multiple color cell characterization and sorting

• CRC & Banking: blood, plasma, serum, cells (bead selection, FLOW), tissue.

• Quantitative Science: Epidemiology, Statistics (R, Prism), literature evaluation PUBLICATIONS

1. Rabinowits, G., Bowden, M., Flores, L., Verselis, S., Vergara, V., Jo, V., Chau, N., Lorch, J., Hammerman, P., Thomas, T., Goguen, L., Annino, D., Schoenfeld, J., Margalit, D., Tishler, R., Haddad, R. (2013). Comparative Analysis of miRNA Expression Among Benign and Malignant Tongue Tissue and Plasma of Patients with Tongue Cancer. Frontier in Oncology. 29 August 2017 doi: 10.3389/fonc.2017.00191 2. Liu Y, Quang P, Braggio E, Ngo H, Badalian-Very G, Flores L, Zhang Y, Sacco A, Maiso P, Azab AK, Azab F, Carrasco R, Rollins BJ, Roccaro AM, Ghobrial IM. (2013) Novel tumor suppressor function of glucocorticoid-induced TNF receptor GITR in multiple myeloma.PLoS One. 2013 Jun 13;8(6):

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3. Roccaro AM, Sacco A, Maiso P, Azab AK, Tai YT, Reagan M, Azab F, Flores LM, Campigotto F, Weller E, Anderson KC, Scadden DT, Ghobrial IM. (2013) BM mesenchymal stromal cell-derived exosomes facilitate multiple myeloma progression. J Clin Invest. 2013 Mar 1. doi:pii: 66517. 10.1172/JCI66517. PMID:23454749

4. Yong Zhang, Aldo M Roccaro, Christopher Rombaoa, Ludmila M Flores, Susanna Obad, Stacey M Fernandes, Antonio Sacco, Yang Liu, Hai Ngo, Phong Quang, Abdel Kareem Azab, Feda Azab, Patricia Maiso, Michaela Reagan, Jennifer R Brown, To-Ha Thai, Sakari Kauppinen, and Irene M Ghobrial (2012) LNA-mediated anti-microRNA-155 silencing in low-grade B cell lymphomas. Blood. 2012 July 26 5. Roccaro AM, Sacco A, Jia X, Banwait R, Maiso P, Azab F, Flores L, Manier S, Azab AK, Ghobrial IM. Mechanisms of activity of the TORC1 inhibitor everolimus in Waldenstrom macroglobulinemia. Clin Cancer Res. 2012 Dec 15;18(24):6609-22. doi: 10.1158/1078-0432.CCR-12-1532. Epub 2012 Oct 9. PMID:23048077 6. Azab AK, Quang P, Azab F, Pitsillides C, Thompson B, Chonghaile T, Patton JT, Maiso P, Monrose V, Sacco A, Ngo HT, Flores LM, Lin CP, Magnani JL, Kung AL, Letai A, Carrasco R, Roccaro AM, Ghobrial IM. (2011) P-selectin glycoprotein ligand regulates the interaction of multiple myeloma cells with the bone marrow microenvironment. Blood 2012 Feb 9;119(6):1468-78..

7. Feda Azab, Abdel Kareem Azab, Patricia Maiso, Teresa Calimeri, Ludmila M. Flores, Yang Liu, Phong Quang, Aldo Roccaro, Antonio Sacco, Hai Ngo, Yong Zhang, Brittany Morgan, Ruben Carrasco, and Irene Ghobrial. (2011) Eph-B2/ephrin-B2 interaction plays a major role in the adhesion and proliferation of Waldenstrom's Macroglobulinemia. Clin Cancer Res. 2012 Jan 1;18(1):91-104

8. Pettersson Filippa, Yau Christina2, Dobocan Monica C, Culjkovic-Kraljacic Biljana, Retrouvay Hélène, Puckett Rachel, Flores Ludmila M.,. Krop Ian E, Rousseau Caroline, Cocolakis Eftihia, Borden Katherine L B3, Benz Christopher C, and Miller, Wilson H Jr.

(2011) Ribavirin treatment effects on breast cancers overexpressing eIF4E, a biomarker with prognostic specificity for luminal B-type breast cancer. Clin Cancer Res. 2011 Nov 1;17(21):6952.

9. Flores, Ludmila; Kindelberger, David; Florentino, Michelangelo; Ligon Azra, Loda Max, Janne Pasi*, Krop Ian*. (2010) Improved yields of circulating tumor cells facilitates molecular characterization and recognition of discordant HER2 amplification in breast cancer. BJC, 1-8.

10. Yang, Xiuwei*, Flores*, Ludmila; Li, Qinlin; Zhang, Pingping; Ian Krop, Ian; Hemler. Martin E. (2010). CD151, a partner of laminin-binding integrins, affects ErbB2-positive mammary tumor progression and Herceptin resistance. *equal contribution. Cancer Res. 2010 Mar 15;70(6):2256-63.

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11. Almog Nova, Henke Vanessa, Flores Ludmila, Hlatky Lynn, Kung Andrew, Wright Renee, Berger Raanan, Hutchinson Lloyd, Naumov George, Bender Elise, Akslen Lars, Achilles Eike-Gert and Folkman Judah. (2006). Prolonged dormancy of human liposarcoma is associated with impaired tumor angiogenesis. FASEB J. 2006 May;20(7):947-9. Epub 2006 Apr 25.

12. Flores-Villanueva, Pedro O; Ruiz-Morales, Jorge A; Chang-Hwa, Song; Flores, Ludmila M.; Eun-Kyeong, Jo, Montaño, Marta; Barnes, Peter F; Selman, Moises; Granados, Julio

(2005). A functional promoter polymorphism in monocyte chemoattractant protein–1 is associated with increased susceptibility to pulmonary tuberculosis. J Exp Med. 2005 Dec 19;202(12):1649-58.

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