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Medical Project Manager

Location:
Lowell, MA
Salary:
negotiable
Posted:
April 29, 2016

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Resume:

DAVID ROBERT BACHINSKY Ph.D.

978-***-****

acukdg@r.postjobfree.com

www.linkedin.com/in/dbachinsky

SUMMARY:

** ***** ** ******** ********** in academia and industry with proven record of management leadership in developing products regulated by FDA.

Training in biochemistry, pathology, and human molecular genetics.

Clinical trial support and documentation

Launch of new research initiatives with leadership responsibilities

Project management, FDA regulated products

Biomarker development, assay development

Gene/cell therapy, cancer vaccine

Applications of synthetic biology for various utilities

SPECIALITIES:

Leadership and management of multiple projects resulting in increased funding, publications, patent applications and FDA approved products. Projects have included lysosomal storage diseases, autoimmune diseases, developmental heart syndromes, gene therapy and DNA repair. Additional translational research activities include microfluidics, nanotechnologies, and novel assay platforms for molecular interactions (pathogens, biomarkers). Recently created a new online graduate course, “Public Health Genomics and Informatics” and I am currently serving on NIH study section for Cell, Molecular and Computational Biology, SBIR grant review committee.

UEXPERIENCE:

Molecular Creativity, Charlotte, NC/Medford, MA Jan 2009-present

Chief Scientific Officer, Molecular Diagnostics and therapeutics. Consultant. Project development includes personalized nutritional supplements and DNA variations. Responsible for applications and engineering of synthetic biology constructs to create novel biologicals. Oversight of projects with direct FDA interactions related to small molecules, DNA, and biologicals.

Fresenius Medical Care North America, Charlotte, NC 2008

Senior Manager Medical Information. Renal Therapies Group.

Contribute to successful launch of a Phase I (bioequivalency) clinical trial, HUhttp://clinicaltrials.gov/ct2/show/NCT00742820U

Responsibilities included: CRO oversight, lab selection, writing clinical protocols, including synopsis, timelines, informed consent forms, investigator brochure and lab manuals. Additional activities included competitive intelligence, due diligence on candidate therapeutics (companies) for dialysis patients.

Intrexon Corporation. Blacksburg, VA 2007

Resident Scholar and Senior Scientist. Strategy and design of DNA constructs, transcriptional therapeutics including novel chimeric molecules for cancer treatments. Focus on sub-cellular localization and modulation of signaling pathways based on protein interaction domains. Temporal-Spatial (motifs) controls engineered into novel transcriptional therapeutics. Responsible for recruiting motif design team, worked with CSO on pre-clinical trials and reported to SVP. Constructs created are in preclinical trials and provisional patents have been filed.

Molecular Creativity, Inc., Andover, MA July 1998-Jan 2007

Founder with multiple consulting projects. Molecular Diagnostics including DNA controls for clinical genetic laboratories. Single molecule assays for infectious diseases/pathogen detection, biosensor development. Project/Product development leading to FDA approved products (Introl, Inspra, Xopenex, Proleukin), publications, and patent applications. Medical/Undergraduate teaching subjects includes: Nutrition, Molecular Biology, Medical Genetics, Pathology, Microbiology and Biochemistry (NECC and St.Eustatius). Consultation/employment includes Pharmacia/Pfizer, Sepracor, Nanobiosym, Formatech, Eisai and MMQCI.

1. NanobiosymU Medford, MA 2005-2006

Senior Scientific Consultant, responsibilities included Single Molecule Assay Development, project management, and supervising a team of technicians, graduate and undergraduate students. Using Biotin modified nucleotides we performed stretching assays with lasers and strepavidin coated beads and cover slips. Molecular Diagnostic bioassay development based on single DNA molecule properties, DARPA funding and military applications in bioterrorism. Studies focused on Gene RADAR, optimizing single molecule laser assays, development of molecular diagnostics and characterization of stretch assays.

2. MMQCI, Scarborough ME 2004

Project Manager/Investigator, Creation of novel DNA based constructs to be used as controls (Introls) for genetic testing laboratories in clinical applications. Created cancer specific DNA translocations (Bcr/Abl, Pml/RARA) molecules for qPCR and these were used as analyte specific reagents (ASRs). qPCR assay development and creation of novel controls used in standardized assays in multiple laboratories as part of NIH initiative and SBIR funding. CLIA lab certification and FDA approvals for LDTs resulted from these activities.

3. St. Eustatius Medical School, Statia, Dutch Antilles 2002-2003

Assistant Professor of Genetics and Biochemistry, taught medical students Molecular Biology, Biochemistry and Medical Genetics.

4. Pharmacia/Pfizer,U Andover, MA 2000-2001

Molecular Scientific Consultant: Reported to the Patent Division. Projects include prior art on hypertension and genotypes associated with salt sensitive individuals and transgenic technologies.

5. Sepracor, Scientific Medical Specialist. Consultant, Marlborough, MA 2000

Wrote review articles on isomeric drugs and improved performance, contributed to FDA filings and designed novel microbiology experiments. Sepracor focused on producing the biologically active, isomeric form of FDA pre-approved drugs, Xopenex is approved for asthma and COPD treatment.

6. Formatech, Project Manager/Staff Scientist, Andover, MA 1998-1999

Directed a group of 6 scientists focused on recombinant derived biologicals and responsible for bioassay development and reformulation of proteins to improve biological activity, for example recombinant interleukin-2 was highly expressed in bacteria and other systems and we improved the refolding of the protein into a biologically active form, improved from 30% to 70% activity.

7. Eisai Research Institute of Boston, Investigator, Andover, MA 1997-1998

Set up a molecular biology/genomics laboratory to perform genomic studies in mice directed to identifying gene(s) involved in an autoimmune disease, Sjogren.s Syndrome.

EDUCATION:

Harvard Medical School. Boston, MA. Department of Genetics. 1994-1997

Howard Hughes Medical Institute- Research Associate. Cloned human cardiac and limb transcription factor TBX5, the Holt-Oram Syndrome research project. The project involved narrowing the disease interval by identification of informative polymorphic markers, contig construction and assembly, and gene identification. Molecular Biological techniques: SNP Discovery, Positional Cloning, Contig (DNA assembly) construction. DNA sequencing/Mutational analysis, Grant and Manuscript writing, research project management (HOS project), and training of pre and postdoctoral fellows.

Tufts University School of Medicine. Boston, MA. 1993-1994

Instructor. Responsible for the characterization of epithelial cells from normal and autosomal dominant polycystic kidney disease. Studies focused on water channels and contribution to cyst formation. Functioned to coordinate research at cellular and molecular level with internal and external collaborators and supervised technicians. Cell Biological Techniques: Cell immortalization, immunological and functional characterization, electrophoresis and Blotting techniques. Construct Expression (Stable and Transient) and Gene Expression Assays. Grant and Manuscript writing, established external and internal collaborations, managed research project including experimental focus and design, and training of technicians and postdoctoral fellows.

Massachusetts General Hospital. Boston, MA. Department of Molecular Biology, Genetics and Pathology 1991-1993

Research Fellow. Postdoctoral Research Project funded by a NIH Fellowship. Responsible for the molecular laboratory set up including acquisition and use of molecular biology equipment. Responsibilities included supervising and training of medical research fellows and technicians in molecular biology techniques. Established both internal and external research collaborations, resulting in publications and grants. Biochemical techniques: Protein purification, Ligand –Receptor Binding assays, Peptide Antibody Production (radioimmunoassays, Westerns, Immunofluorescence). Immunohistochemical Analysis, Construct Expression (Stable and Transient) and Gene Expression Assays. Grant and Manuscript writing, project management, established internal and external collaborations and trained pre and other postdoctoral fellows in molecular biological techniques.

Saint Louis University Medical School, St. Louis, Missouri. 1990

Biochemistry and Molecular Biology Ph.D., “The molecular genetics of human beta-glucuronidase in normal and mucopolysaccharidosis VII (Sly Syndrome) fibroblasts.”

University of Massachusetts, Lowell, Massachusetts. 1983-1984

M.S. Biology. Department of Chemistry Fellowship.

PEACE CORPS 1980-1982

Fisheries Program, Project in Congo/Zaire, Africa

La Salle University, B.A. Chemistry, Philadelphia, Pennsylvania 1980

FELLOWSHIPS CERTIFICATES AND AWARDS:

1994-1997. Howard Hughes Medical Institute, Research Associate.

1991-1993. N.R.S.A. National Institute of Health, Post Doctoral Fellowship.

1986-1989. N.R.S.A. National Institute of Health, Predoctoral Fellowship.

1984-1985. Edward A. Doisy Nobel Prize Fellowship

SELECTED TALKS AND SEMINARS:

NIH-NIDCR

NIH-NHGRI

Genentech

Virginia Bioinformatics Institute, Virginia Tech

George Washington University Medical Center

Harvard Medical School, Department of Genetics

University of Montreal, Department of Physiology

Massachusetts General Hospital, Department of Pathology

National Institutes of Health, Department of Biochemistry

Boston University School of Medicine, Pulmonary Division,

Food and Drug Administration, Department of Cell Biology

Tufts University School of Medicine, Division of Nephrology

Picower Research Institute, Department of Biochemistry

Cornell University School of Medicine, Department of Cell Biology

Boston University School of Medicine, Department of Nephrology

Tufts University School of Medicine, Department of Cell Biology

Massachusetts General Hospital, Department of Pathology

New York University School of Medicine, Pathology Department

American Red Cross, Department of Biochemistry

Boston University School of Medicine, Biophysics Department

Massachusetts General Hospital, Renal Division

MEMBERSHIPS:

American Society of Biochemistry and Molecular Biology

American Society for Cell Biology

American Society of Human Genetics

American Society of Microbiology

Biophysical Society

Regulatory Affairs Professional Society

Certifications:

Network Analysis in Systems Biology

Coursera

Understanding and Improving the US Healthcare System

Coursera

Bioinformatic Methods I

Coursera

January 2014 – Present

Introduction to Genetics and Evolution Coursera

Bioinformatic Methods II

Coursera

April 2014

Genomic and Precision Medicine(Link)

Coursera

June 2014

Introduction to Systems Biology(Link)

Coursera

June 2014

Introduction to Human Behavioral Genetics(Link)

Coursera

July 2014

Nanotechnology and Nanosensors(Link)

Coursera

Statistical Reasoning for Public Health 1: Estimation, Inference, & Interpretation

Coursera

Experimental Methods in Systems Biology

Coursera

Medical Neuroscience

Coursera

Understanding the Brain: The Neurobiology of Everyday Life

Coursera

Epigenetic Control of Gene Expression

Coursera

PUBLICATIONS:

Patents Published:

PP1 Ligands. 2008 The invention relates to phosphatase ligands and polyligands. In particular, the invention relates to ligands, homopolyligands, and heteropolyligands that modulate PP1 activity. The ligands and polyligands are utilized as research tools or as therapeutics. The invention includes linkage of the ligands, homopolyligands, and heteropolyligands to a cellular localization signal, epitope tag and/or a reporter. The invention also includes polynucleotides encoding the ligands and polyligands.

MEK LIGANDS AND POLYNUCLEOTIDES ENCODING MEK LIGANDS 2008 The invention relates to kinase ligands and polyligands. In particular, the invention relates to ligands, homopolyligands, and heteropolyligands that modulate MEK activity. The ligands and polyligands are utilized as research tools or as therapeutics. The invention includes linkage of the ligands, homopolyligands, and heteropolyligands to a cellular localization signal, epitope tag and/or a reporter. The invention also includes polynucleotides encoding the ligands and polyligands.

1. Basson, C., T. Huang, R. Lin, D. R. Bachinsky, S. Weremowicz, A. Vaglio, R. Bruzzone, R. Quadrelli, M. Lerone, G. Romeo, M Silengo, C Morton, M. Pierpont, C. Muller, C. Seidman, and J. Seidman. (1999) Different TBX5 interactions in Heart and Limb defined by Holt-Oram Syndrome mutations. Proc.Nat.Acad.Sci. 96(6):2919.

2.Jung, F.F., D.R. Bachinsky, S. Tang, G. Zheng, D. Diamant, I. Haveran, R.T. McCluskey, and J.R. Ingelfinger. (1998)Immortalized rat proximal tubule cells express membrane and soluble megalin. Kidney International. 53 (2) 358.

3. * D.R. Bachinsky, * Basson, C.T, R.C. Lin, T. Levi, J. Elkins, J. Soults, D. Grazel, E. Kroumpouzou, T.A. Traill, L.B. Holmes, J. Leblanc-Straceski, B. Renault, R. Kucherlapati, J.G. Seidman, and C.E. Seidman. (1997) Mutations in TBX5 cause defects in human limb and heart morphogenesis. Nature Genetics. 15:30.

*Considered Joint First Authors (cited over 600 times)

4. Tang., S.S., F. Jung, D. Diamant, D. Brown, D. Bachinsky, P. Hellman, and J. Ingelfinger. (1995) Temperature sensitive SV40 immortalized rat proximal tubule cell line has functional renin-angiotensin system. American Journal of Physiology. 268:F435.

5. Bachinsky, D., I. Sabolic, D. Emmanouel, F. Carone, D. Brown, and R. Perrone. (1995) Water channel expression in human ADPKD kidneys. American Journal of Physiology. 268:F398.

6. Abbate, M., D. Bachinsky, R. McCluskey, and D. Brown. (1994) Expression of gp330 and gp330/a2-Macroglobulin receptor-associated protein (RAP) in rat tubular differentiation. Journal of the American Society of Nephrology. 4:2003.

7. Zheng, G., D. Bachinsky, I. Stamenkovic, D. Strickland, G. Andres, D.Brown, and R. McCluskey. (1994) Organ distribution in rat of GP330, LRP/a2-macroglobulin receptor and their associated protein, 39 kDa RAP, Journal of Histochemistry and Cytochemistry. 42:531.

8. Xia, Y-R., D.R. Bachinsky, J.A. Smith, R. T. McCluskey, C.H. Warden and A. Lusis. (1993) Chromosomal mapping of the glycoprotein 330 (GP330) gene in the mouse. Genomics 17:760.5.

9. Abbate, M., D. Bachinsky, G. Zheng, I. Stamenkovic, M. McLaughlin, R. McCluskey, and D. Brown. (1993) Localization of 39KD GP330-associated protein (RAP) and RAP binding sites in kidney: Redistribution of endogenous RAP in unfixed kidney sections. European Journal of Cell Biology, 61:139.

10. Bachinsky, D., G. Zheng, J. Niles, M. McLaughlin, M. Abbate, G. Andres, D. Brown, and R. McCluskey. (1993) Detection of two forms of GP330: Their role in Heymann Nephritis. American Journal of Pathology, 143:598.

11. Shipley, M., M. Klinkenberg, B. Wu, D. Bachinsky, J. Grubb and W. Sly. (1993) Mutational analysis of a patient with mucopolysaccharisosis VII deficiency and identification of pseudogenes. American Journal of Human Genetics, 52:517.

12. Bachinsky, D. The molecular genetics of human beta-glucuronidase in normal and mucopolysaccharidosis VII fibroblasts. (1991) Doctoral Thesis, Available from University Microfilms International, Ann Arbor, MI.

13. Miller, R., J. Hoffmann, P. Powell, J. Kyle, J. Shipley, D. Bachinsky, and W. Sly. (1990) The cloning and characterization of the human beta-glucuronidase gene. Genomics 7:280.

REVIEWS:

1. Bachinsky, D.R. and R. D. Perrone. (1995) Autosomal Dominant Polycystic Kidney Disease: Identification of the Major Gene. The Genetic Resource. 9:5.

2. Zheng, G., D.R. Bachinsky, M. Abbate, G.. Andres, D. Brown, I. Stamenkovic, J.L. Niles, and R. T. McCluskey.(1994) Gp330: Receptor and autoantigen. Annals New York Academy of Sciences. 737:154.



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