Senior Director Vice President

Confidential COnfidential, PH.D.

Rockville, Maryland

123-***-**** *********@*****.*** linkedin.com/in/zsandalon

VICE PRESIDENT SENIOR DIRECTOR

QUALIFICATIONS PROFILE

Self-motivated, innovative, and goal-oriented professional with extensive clinical research experience in biotechnology industry; coupled with strong leadership background. Equipped with proven ability to develop and articulate a compelling long-term vision and implement an aligned strategy that will ensure high-quality outcomes. Expert at gene therapy and virus vectors, from concept design through process development into GMP manufacturing for phase I/II clinical trials. Highly regarded for solid analytical skills in building ideas and hypotheses regarding organizational processes to drive a performance-oriented decision-making approach. Known for outstanding teamwork, communication, and interpersonal aptitudes along with proficiency in networking, developing relationships, and establishing credibility with key senior stakeholders. Areas of expertise include:

Strategic Planning Process Development Project Management Staff Leadership and Training People Development

LEADERSHIP EXPERIENCE

Confidential - Rockville, MD

Senior Director of Process Development 2020–Present

Director, Process Development 2018–2020

●Hold responsibility for the coordination and management of staff and their workload related to process development and GMP manufacturing (CMC), as well as upstream and downstream operations, including process development, technology transfer, and manufacturing.

●Lead the identification, establishment, and optimization of processes based on client specifications, applicable standards, and all necessary safety and regulatory requirements.

●Efficiently oversee resources, schedule, and overall staffing plan in support of the company’s financial targets, as well as all budgetary items related to the process development and manufacturing areas.

●Ensure the expansion of service offerings by conducting technical due diligence on new platforms and technologies.

●Manage the Business Development Team to create business proposals for government or commercial clients, while defining strategy and relevant sections of the proposals.

●Demonstrate expertise in scientific and technical elements in managing commercial and government contracts.

●Actively function as member of the organization leadership team.

Associate Director, Innovation and Translation 2016–2018

●Served as principal investigator and co-principal investigator in multi-year government contracts (NIAID) for vaccine development and manufacturing.

●Performed close monitoring of cost, schedule, and performance of the projects.

●Exemplified competency in the pre-clinical development of biologics and small molecule drugs used for the prevention and treatment of infectious diseases.

RESEARCH AND DEVELOPMENT EXPERIENCE

Confidential - Rockville, MD

Senior Staff Scientist, Translational Sciences 2014–2016

●Actively functioned as technical lead and imparted knowledge to the product development teams on pre-clinical development, including process design, manufacturing, quality control, and regulated activities such as GLP and cGMP.

●Took charge of generating, reviewing, and gathering information for product development plans to drive the formulation of promising vaccine and therapeutic candidates.

Confidential - Germantown, MD

Senior Translational Scientist and Team Leader 2010–2012

●Carried out the design, coordination, and execution of in vivo studies for proof-of-concept and in support of pre-clinical development of potential gene-therapy and anti-cancer drug candidates.

●Built, directed, and implemented cross-functional plans for three major programs, involving anemia/kidney, ocular, and inflammatory diseases.

●Assisted in completing regulatory filings and identifying and prioritizing research opportunities for potential new therapies.

●Rendered direct supervision and support to scientific staff in the organization, as well as technical and regulatory guidance to operational staff.

●Took part in creating and implementing new technologies.

●Maintained regular communication with external and internal partners, including consultants/research vendors, contract research organizations (CROs), and key opinion leaders

●Demonstrated flexibility and multitasking skills in fulfilling diverse roles:

−Representative of program teams at senior management meetings and project reviews to monitor project performance

−Technical resource within the company to determine technologies for product delivery (virus and non-virus), testing (bio-assay, bio-analytics, and high-throughput screening), and validation

Earlier Positions Held:

International AIDS Vaccine Initiative (IAVI), New York, NY

Principal Scientist

Targeted Genetics Corporation, Seattle, WA

Staff Scientist I & II, Drug Discovery

Stony Brook University, Stony Brook, NY

Post Doctorate Research Fellow, Department of Molecular Genetics & Microbiology

TEACHING EXPERIENCE

SUNY – Farmingdale State College, Farmingdale, NY

Visiting Professor, Undergraduate School, Biology Department 2012–2014

SUNY - Downstate Medical School, Brooklyn, NY

Research Assistant Professor 2008–2010

EDUCATION

Hebrew University Hadassah Medical School, Jerusalem, Israel

Doctor of Philosophy in Molecular Biology

Hebrew University Hadassah Medical School, Jerusalem, Israel

Master of Science in Biotechnology

Ben-Gurion University, Be`er-Sheva, Israel

Bachelor of Science in Biology

PUBLICATIONS

Journal Articles:

Kimchi-Sarfaty, C., Arora, M., Sandalon, Z., Openheim, A., and Gottesman, M. M. (2003). High cloning capacity of in vitro packaged SV40 vectors with no SV40 virus sequences. Human Gene Therapy, 4(2), 167-177. https://doi.org/10.1089/104303403321070865

Oppenheim, A., Sandalon, Z., Peleg, A., Shaul, O., Nicolis, S., and Ottolenghi, S. (1992). A cis acting DNA signal for encapsidation of simian virus 40. Journal of Virology, 66(9), 5320-5328. https://doi.org/10.1128/jvi.66.9.5320-5328.1992

Oppenheim, A., Siani, M., Sandalon, Z., and Mengeritsky, G. (1994). Dynamics of the nucleoprotein structure of simian virus 40 regulatory region during viral development. Journal of Molecular Biology, 238(4), 501-513. https://doi.org/10.1006/jmbi.1994.1310

Palumbo, G. A., Yarom, N., Gazit, A., Sandalon, Z., Baniash, M., Levitzki, A., and Ben-Yehuda, D. (1997). The tyrphostin AG17 induces apoptosis and inhibition of CDK2 activity in a lymphoma cell line that over expresses bcl2. Cancer Research, 57(12), 2434-2439. https://cancerres.aacrjournals.org/content/57/12/2434

Sandalon, Z. and Oppenheim, A. (1997). Self-assembly and protein-protein interactions between the SV40 capsid proteins produced in insect cells. Virology, 232(2), 414-421. https://doi.org/10.1006/viro.1997.8796

Sandalon, Z., Bruckheimer, E. M., Lustig, K. H., and Burstein, H. (2007). Long-term suppression of experimental arthritis following intramuscular administration of a pseudotyped AAV2/1-TNFR:Fc vector. Molecular Therapy, 15(2), 264-269. https://doi.org/10.1038/sj.mt.6300043

Sandalon, Z., Bruckheimer, E. M., Rogers, L., Lustig, K. H., Peluso, R., and Burstein, H. (2004). Secretion of soluble TNFR:Fc fusion protein following administration of AAV-TNFR:Fc vectors pseudotyped with capsids of alternate AAV serotypes. Journal of Virology, 78(22), 123**-*****. https://doi.org/10.1128/JVI.78.22.12355-12365.2004

Sandalon, Z., Dalyot-Herman, N., Oppenheim, A. B., and Oppenheim, A. (1997). In Vitro assembly of SV40 virions and pseudovirions: vector development for gene therapy. Human Gene Therapy, 8(7), 843-849. https://doi.org/10.1089/hum.1997.8.7-843

Sandalon, Z., Fusenig, N. E., McCutcheon, J., Taichman, L. B., and Garlick, J. A. (2001). Suicide gene therapy for premalignancy: A new strategy for the treatment of intraepithelial neoplasia. Gene Therapy, 8(3), 232-238. https://doi.org/10.1038/sj.gt.3301344

Sandalon, Z., Gnatenco, D. V., Bahou, W. F., and Hearing, P. (2000). AAV Rep protein enhances the generation of a recombinant mini-adenovirus vector utilizing Ad/AAV hybrid virus. Journal of Virology, 74 (22), 103**-*****. https://doi.org/10.1128/JVI.74.22.10381-10389.2000

Chapters in Books

Oppenheim, A., Dalyot, N., Peleg, A., Sandalon, Z., and Rachmilewitz, E. A. (1992). Development of somatic gene therapy: A simian virus 40 pseudoviral vector for hemopoietic cells. In Bonne-Tamir, B. and Adam, A. (Eds.), New perspectives on genetic markers and diseases among the Jewish people. Oxford University Press Inc. ISBN: 978-0195068177

Sandalon, Z. and Oppenheim, A. (2000). Production of SV40 proteins in insect cells and in vitro assembly of virions and pseudovirions. In Raptis, L. (Ed.), Methods in molecular biology (165:119-128). Humana Press Inc. https://doi.org/10.1385/1-59259-117-5:119

PATENTS

Hearing, P., Sandalon, Z., Gnatenco, D. V., and Bahou, W. F. (2005). Hybrid adenovirus/adenoassociated virus vectors and methods of use thereof (U.S. Patent No. 6,916,635). The Research Foundation of State University of New York.

https://patents.justia.com/patent/7563617

Oppenheim, A., Dalyot, N., Ben-Nun-Shaul, O., Rund, D., Sandalon, Z., Chajek-Shauland, T., and Metzger, S. (2000). SV40-derived DNA constructs comprising exogenous DNA sequences (US Patent No. 6,090,608). Yissum Research Development Company of the Hebrew University of Jerusalem, Hadasit Medical Research Services and Development Company Limited. https://patents.justia.com/patent/6090608

Sandalon, Z., Oppenheim, A., and Oppenheim, A. (2000). In vitro construction of SV40 viruses and pseudoviruses (Australian Patent No. 719601). Yissum Research Development Company of the Hebrew University, Hadasit Medical Research Services and Development Company. http://patents.justia.com/patent/6830929

Sandalon, Z., Oppenheim, A., and Oppenheim, A. (2004). In vitro construction of SV40 viruses and pseudoviruses (US Patent No. 6,830,929) Yissum Research Development Company of the Hebrew University, Hadasit Medical Research Services and Development Company. http://patents.justia.com/patent/6830929

Contact this candidate