GABRIEL M. GUTIERREZ, Ph.D.

**** ******* ***

Kensington, MD 20895

hlpm8n@r.postjobfree.com

617-***-****

EDUCATION

• Ph.D., Genetics, University of Connecticut, Storrs, Connecticut

• B.S., Biology, Loyola University, Chicago, Illinois

PROFESSIONAL SUMMARY

• Project Management

I am currently a Project Manager with Science Applications International Corporation’s (SAIC) Civilian Health and Life Sciences Operation. Among the various commercial and government contracts, SAIC serves as the prime contractor for the Malaria Vaccine Production and Support Services (MVPSS) for the National Institute of Allergy and Infectious Diseases’ (NIAID) efforts to advance Malaria vaccine candidates into clinical trials. Within this contract I serve as a project manager for SAIC. SAIC is responsible for the virtual development and manufacture of several malaria vaccine candidates. Accordingly, I have managed several manufacturing campaigns that have resulted in the delivery of clinical trial material. Specifically, I have taken the lead in the development of an HLA, multi-epitope DNA vaccine that has been delivered to the government along with a draft IND. This effort required the management of a team of technical, regulatory, and financial assets within SAIC. In addition to my in house management efforts I also performed the technical and contractual oversight of several subcontractors to provide the services under current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP) for pre-clinical testing. Further, by my own initiative, I have performed literature searches and developed white papers for identifying potential new candidates, novel expression platforms, and promising vaccine delivery platforms for NIAID’s vaccine pipeline. These efforts have led to NIAID funding for several of these concepts, which have added to their candidate portfolio of candidates for NIAID and consequently increased revenue for SAIC.

I have also been involved in managing research subcontractors for the Spinal Muscular Atrophy (SMA) Project: a collaborative program to accelerate therapeutics for SMA. This 4-year, $22 million contract with the National Institutes of Neurological Disorders and Stroke (NINDS) supports a fast-track program for solicitation through the award of subcontracts and a collaborative, virtual company for drug development. These subcontractors support research and facilities for an iterative, small-molecule therapeutics program.

• Regulatory Support

Along with providing technical direction to the design and manufacture of malaria vaccines and small molecules, I provide programmatic assistance to the regulatory affairs staff in tracking, compiling, coordinating, and overseeing regulatory-based activities. I also supply the technical information in support of vaccine IND files as well as coordinating and participating in GMP/GLP subcontractor audits. I have conducted over a dozen audits as part of my duties as lead scientific monitor of several subcontractors.

• Data Analysis and Technical Writing

I have also lent my professional expertise in genetics and cancer biology in support of SAIC’s contract with the Office of Science Planning and Assessment (OSPA) at The National Cancer Institute (NCI). Briefly, I have performed data analysis and technical writing for biomedical research program evaluation and planning. Additionally, I supported the Congressionally Directed Medical Research Program (CDMRP) at SAIC with grant report review and technical writing.

• Laboratory Management and Teaching

While receiving my doctoral degree in Genetics, I taught six semesters of undergraduate genetic classes in the biology department at the University of Connecticut, which involved preparation and delivery of lectures, exams, and student evaluation. Throughout my graduate and postdoctoral training, I was continually involved in training and supervising any number of graduate and undergraduate students as well as technicians in laboratory techniques and the basic principles of molecular biology. I also taught one semester of scientific ethics at Harvard Medical School. This consisted of facilitating the analysis of scenarios and actual cases of scientific fraud and misconduct to help graduate students identify and avoid such misbehavior in their careers.

PROFESSIONAL EXPERIENCE

• June 2007 to Present

Project Manager, SAIC, Civilian Health and Life Sciences Operation, Frederick, Maryland

SAIC ostensibly serves as the project management and regulatory arm for the NIH’s extramural malaria vaccine development enterprise. I am responsible for identifying suitable sub-contractors to perform tasks, which requires auditing vendor’s facilities to asses their ability to perform work under current Good Laboratory/Manufacturing Practices (cGLP/cGMP), preparing comprehensive Statements of Work (SOW), and managing the on time, quality delivery of reports and products from sub-contractors. This work includes the manufacture of Drug Substance and Drug Product, release/characterization testing, stability programs, preclinical studies, and regulatory support. I also control the budget of several of the subcontractors under my supervision.

Along with his my project management efforts for the MVPSS contract, I played a major technical and managerial role for the SMA project. Specifically, I directed several subcontractors in providing regulatory and laboratory support towards developing a small molecule capable of increasing the levels of the SMN, which is deficient in SMA patients. I was directly involved in soliciting research proposals and convening panels of scientific experts for proposal review, awarding research subcontracts, and monitoring the course of subcontracted research projects and working with funded investigators to achieve performance milestones. Specifically, I wrote and implemented a validation protocol for an ELISA kit, oversaw the design of an automated biological readout assay, managed the efficacy testing of small-molecule candidate compounds in a SMA mouse model, and oversaw a non-clinical, primate study in support of a lead candidate.

• November 2003 to June 2007

Research Associate, Tufts-New England Medical Center (NEMC), Boston, Massachusetts

During my stay at Tufts, I was primarily responsible for the development of mouse models in the study of cancer development in the laboratory of Dr. Philip Hinds at the Molecular Oncology Institute at Tufts-NEMC. I planned and provided oversight for the performance of several research projects and protocols. I was also responsible for the education and direction of several undergraduate and graduate students in the laboratory. My research interests were centered around uncovering the role of the retinoblastoma protein (pRb) in bone development and osteosarcoma, and my research efforts resulted in the publication of three scientific articles in peer-reviewed journals, a scientific review, and I presented and received recognition for my work at national and international scientific meetings. I also presented my work at the Cancer Stem-Cell Workshop in Milan, Italy.

• May 2001 to October 2003

Postdoctoral Fellow, Harvard Medical School, Boston, Massachusetts

My primary responsibility as a post-doc was to design and conduct laboratory experiments and analyze results to develop a better understanding of the role of the tumor suppressor pRb in coordinating proliferation and differentiation. I applied my understanding of genetics to generate a conditional, bone-specific knock-out mouse of pRb. Applying a variety of biochemical, molecular, cellular, and whole-animal techniques, I identified pRb’s specific role in the bone. I successfully published one peer-reviewed article and presented and received recognition for his work at national meetings. I competed in and attended the Pathobiology of Cancer Workshop in Keystone, Colorado. Furthermore, I was responsible for the training and supervision of technicians, undergraduates, and graduates in the laboratory.

COMPUTER PROFICIENCY

• Hardware:

o PC

o Macintosh

• Software:

o Microsoft Office (Word, Excel, PowerPoint, Access, Project)

o Adobe (Photoshop, Acrobat)

PROFESSIONAL TRAINING

• Current Good Laboratory Practices and Current Good Manufacturing Practices (The Center for Professional Innovation & Education)

• Project management training

o Project Management 101, Managing Projects Course (George Washington University)

o Project Management 201, Scheduling and Cost Control (George Washington University)

o PMP certification is currently being obtained

• Pathobiology of Cancer Workshop, Keystone, CO (AACR)

• International Cancer Stem-Cell Workshop, Milan, Italy (SEMM)

AWARDS AND GRANTS

• Named as one of the top “Forty under Forty” Hispanic scientists by Hispanic Engineer magazine.

• NIH Minority Postdoctoral Supplement, AG20208, 2002–2005

• National Research Service Grant for First Year of Postdoctoral Work in Cancer at Harvard Medical School, Department of Pathology, 2001–2002

• New England Board of Higher Education Fellowship for Doctoral Studies, 1994–2001

PUBLICATIONS

1. Gabriel Gutierrez, Elizabeth Kong, Yves Sabbagh, Nelson Brown, Jong-Seo Lee, Marie Demay, David Thomas, and Philip Hinds Impaired bone development and increased mesenchymal progenitor cells in calvaria of RB1-/- mice PNAS 2008 Nov 25;105(47):18402-7,

2. Lee JS, Thomas DM, Gutierrez G, Carty SA, Yanagawa S, Hinds PW. HES1 cooperates with pRb to activate RUNX2-dependent transcription. J Bone Miner Res. 2006 Jun;21(6):921-33.

3. Gutierrez GM, Kong E, Hinds PW. Master or slave: the complex relationship of RBP2 and pRb. Cancer Cell. 2005 Jun;7(6):501-2.

4. Sage C, Huang M, Karimi K, Gutierrez G, Vollrath MA, Zhang DS, García-Añoveros J, Hinds PW, Corwin JT, Corey DP, Chen ZY. Proliferation of functional hair cells in vivo in the absence of the retinoblastoma protein. Science. 2005 Feb 18;307(5712):1114-8. Epub 2005 Jan 13

5. Thomas DM, Johnson SA, Sims NA, Trivett MK, Slavin JL, Rubin BP, Waring P, McArthur GA, Walkley CR, Holloway AJ, Diyagama D, Grim JE, Clurman BE, Bowtell DD, Lee JS, Gutierrez GM, Piscopo DM, Carty SA, Hinds PW. Terminal osteoblast differentiation, mediated by runx2 and p27KIP1, is disrupted in osteosarcoma. J Cell Biol. 2004 Dec 6;167(5):925-34.

6. Reinholdt LG, Gutierrez GM, Krider HM. Meiotic chromosome missegregation during apyrene meiosis in the gypsy moth, Lymantria dispar, is preceded by an aberrant prophase I. Chromosoma. 2002 Sep;111(3):139-46. Epub 2002 Jul 31.

FOREIGN LANGUAGES

• Spanish

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