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Development Project Clinical Manager Product Molecular Biology

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Country: United States
State: Maryland
City: Frederick
ZIP: 21702
Posted date: 4/13/2012   all resumes
Contact Info: ********.*****@**.****.***
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**** ******* *****, *********, **. 21702
PHONE: (301) ***-**** OR (301) ***-**** • E-MAIL:

Walter Reed Army Institute of Research
Vaccine Research and Development
Military Infectious Disease Research Project (MIDRP)
Principal Scientist (Microbiologist/Vaccine Development) Present
Project development, which includes proposal writing proposals and defending them at the review by a team of outside experst convened by AIBS. Also included in the proposal are budgeting, personnel development, milestones, status reports: mid-year and final report. Integrated product development Team Committee Secretary responsible for minutes of the meeting and member of the Scientific Committee.
Projects Successfully Completed:
1)Development of a mutant E. coli strain for the expression of N. meningitidis membrane proteins in the NOMV.
2)GMP production of two components of a trivalent Meningococcal vaccine.
3)Determining the safety and immunogenicity of an experimental trivalent Meningococcal vaccine (Determining the correlates to protection for meningococcal infections).
4)Characterizing the immune response of an experimental trivalent Meningococcal vaccine to serogroup B N. meningitidis strains. Determining the potency of the experimental trivalent Meningococcal vaccine to all major serogroups N. meningitidis strains.
5)Developed a whole blood cytokine release assay for testing the safety of vaccines containing LPS (Bioassay development).
6)Construction of PorA targets for analysis of the potency of the experimental trivalent vaccine.
7)Collaborated with Dr. Lee at the FDA on the development of a multivalent conjugate vaccine for N. meningitidis.

Project related duties including supervision and hands on Laboratory work detailed below:
Duties: Molecular Biology and Immunology
1)Developed and characterized vaccine strains.
2)Produced lab lots of the vaccine for initial potency studies.
3)Coordinated cell bank production, fermentation, purification and bottling of the vaccine.
4)Characterized the GMP produced vaccine lots (Physico-chemical characterization) and compare them to the 10L Lab Benchtop fermenter lots. Bulk lots, purified lots and bottled vaccine characterization. Batch Process Records (BPRs) completion as part of product development (vaccine lots release), BPR#896-00, BPR#904-00, BPR#934-00, BPR#942-00, and BPR#946-00.
5)Analyzed the GMP produced experimental vaccine for the Potency and immunotoxicity of vaccine preparations in animals, Pre-Clinical Testing for IND.
6)Analyzed human and mouse serum for Abs against experimental group B N. meningitidis vaccine, Clinical Trials.
7)Expressed, purified and characterized proteins.
8)Completed the Safety/Toxicology studies on the experimental vaccine.
9)Developed the whole blood cytokine release assay as part of the safety studies for the LOS in the vaccine.
10)Collaborated with FDA scientist on conjugate vaccine development.
11)Supervised Technicians.
12)Transferred the vaccine technology to a Commercial Partner.

GENEWORKS, INC. Ann Arbor, Michigan
Development of transgenic chickens and the production of monoclonal antibodies.
Project related duties including supervision and hands on Laboratory work detailed below:
Duties: Molecular Biology/Retrovirology and Immunology
Developed retoroviral vectors for the production of Transgenic chickens.
Produced Transgenic chickens and mAbs.

Study T cell Leukemias and T cell development in mice. Also produce monoclonal antibodies to Cell surface proteins of T cells. Purification of monocytes and lymphocytes, proteins and antibodies


GCP /ICH and GLP courses at the WRAIR
Contracting Officer/Grant Officer Representative Training Certificate (USAMRAA)

Selected Research Publications
1.Moran EE, Burden R, Labrie III JE, Wen Z, Wang X-M, Zollinger, WD, Zhang L and Pinto VB. Analysis of the Bactericidal response to an Experimental Neisseria meningitidis vesicle vaccine (2012). Clin. Vaccine Immunol., in press.
2.Pinto VB, Moran EE, Cruz F, Wang X-M, Fridman A, Zollinger WD, Przysiecki CT, Burden R (2011). An experimental outer membrane vesicle vaccine from N. meningitidis serogroup B strains that induces serum bactericidal activity to multiple serogroups. Vaccine , 29, 7752-7758.
3.Keiser PB, Biggs-Cicatelli S, Moran EE, Schmiel DH, Pinto VB, Burden RE, Miller LB, Moon JE, Bowden RA, Cummings JF, Zollinger WD (2011). A phase 1 study of a meningococcal native outer membrane vesicle vaccine made from a group B strain with deleted lpxL1 and synX, over-expressed factor H binding protein, two PorAs and stabilized OpcA expression. Vacine, 29, 1413-1420.
4.Paul B Keiser, Barnett T Gibbs, Trinka S Coster, E Ellen Moran, Mark B Stoddard, Joseph E Labrie 3rd, Deborah H Schmiel, Valerian Pinto, Ping Chen, Wendell D Zollinger (2010). A phase 1 study of a group B meningococcal native outer membrane vesicle vaccine made from a strain with deleted lpxL2 and synX and stable expression of opcA.
Vaccine, 28, 6970-6976.
5.Zollinger, W., Donets, M., Schmiel, D., Pinto, V. B. et al (2010). Design and Evaluation in Mice of a Broadly Protective Meningococcal Group B Native Outer Membrane Vesicle Vaccine. Vaccine, 28, 5057-5067.
6.Stoddard, M.B., Pinto, V., Keiser, P. B., and Zollinger, W. Evaluation of a whole-blood
cytokine release assay for use in measuring endotoxin activity of group B
Neisseria meningitidis vaccines made from lipid A acylation mutants.
Clin Vaccine Immunol, 2010. 17(1), 98-107.
7.Pinto, V. B., Prasad, S., Yewdell, J.W., Bennink, J.R., and Hughes, S.H. (2000). Restricting
expression prolongs the expression of foreign genes introduced into animals by retroviruses.
J. Virol. 74:10202.
8.Pinto, V. B., and Rock, K. L. (1994). Extracellular matrix-induced stimulation of CD4-8- Thymic T cell line. Cell. Immunol., 155:144.
9.Pinto, V.B., Riley, R.L., and Peacock, J.S. (1991). Anti-Ig inactivation of CH31 model of immature B cell inhibits its ability to process pigeon cytochrome c. Mol. Immunol. 28:1311.
10.Pinto, V.B., and Rock, K.L. (1991). Characterization of the proliferative response of a CD4-8- thymic T-lymphoma cell line to stimulation by thymic cellular elements. J. Immunol. 147:42
11.Peacock, J.S., Colsky, A.S., and Pinto, V.B. (1990). Lectins and antibodies as tools for studying cellular interactions. J. Immunol. Methods. 126:147.
12.Pinto, V.B., Riley, R.L., and Peacock, J.S. (1989). Effects of IL-4 on neonatal B cell tolerance. Biochem. Biophys. Res. Comm. 164:199.
13.Pinto, V.B., Gelder, F.B., and Morris, M.D. (1986). Purification, partial characterization and clinical evaluation of an Adenocarcinoma Associated Antigen. Cancer Res., 46:6520-6524.
14.Gelder, F.B., and Pinto, V.B. (1989). Clinical markers in the diagnosis of cancer. In: Medical Radiology, Diagnostic Imaging and Radiation Oncology". Radiation therapy of malignancies of the alimentary tract. R.R. Dobelbower, ed., Springer-Verlag, Chapter II, Tumorigenesis and tumor markers page 3-17.

Selected Presentations at Meetings
1.Pinto, V.B., Moran, E. E., Schmiel, D.H., Stoddard, M.B., Labrie, J.E., Ionin, B.,
Marques, R., and Zollinger, W.D. (2008). Analysis of the immune response to an investigational three component N. meningitidis NOMV vaccine in mice. IPNC in Rotterdam, Netherlands
2.Labrie, J. E., Donets, B., Ionon, B., Marques, R., Moran, E., Pinto, V. B., Schmiel, D.,
and Zollinger, W. D. (2008). Immunogenicity of a native outer-membrane vesicle vaccine for N. meningitidis serogroup B in rabbits. IPNC in Rotterdam, Netherlands.
3.Pinto, V. B., Prasad, S., Yewdell, J.W., Bennink, J.R., and Hughes, S.H. (1999).
Restricting expression of foreign genes to muscle cells diminishes the immune response and prolongs expression. Retrovirus Meeting, Cold Spring Harbor, N.Y.
4.Pinto, V. B., Riley, R. L., and Peacock, J. S. (1989). Effect of IL-4 on neonatal B cell
tolerance. Federation of the American Society of Experimental Biologist, New Orleans.
5.Pinto, V. B., and Peacock, J. S. (1988). The role of lipid in transmembrane
signalling. Federation of the American Society of Experimental Biologist, Las Vegas, NV
6.Pinto, V. B., and Gelder, F. B. (1986). Identification and purification of Immune-complex
containing an Adenocarcinoma-Associated tumor antigen. American Society of Microbiology South Central Branch, Shreveport, LA.
7.O'Mara, T., Pinto, V. B., and Gelder, F. B. (1986). Clinical Evaluation of monoclonal antibodies to organ associated epitopes of ACAA. American Society of Microbiology South Central Branch, Shreveport, LA.

Research Support as Principal Investigator by the Military Infectious Disease Research Program
1.Endotoxin assay using human monocytes ($253K) M0005_08_WR 2008
2.Manufacture of cGMP vaccines ($442K) M0003_08_WR 2008-2010
3.E. coli NOMVs with Neisseria proteins ($166K) M0012_09_WR 2009
4.Pre-Clinical Animal studies of the Meningococcal WM0003_10_WR 2010
Vaccine ($570K)
5.Construction of PorA targets for analysis of the WM0015_11_WR 2011
potency of the experimental trivalent vaccine ($270K)
6.Analyzing the potency of the experimental trivalent WM0017_12_WR 2012
group B vaccine against other N. meningitidis
serogroups. ($400K)
References provided upon request

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