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Director of R&D

Location:
New Braunfels, TX
Posted:
July 04, 2015

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Resume:

Erik V Verona, PhD

*** *** ***** *****, *** Braunfels, TX 78132

www.linkedin.com/in/erikverona/

acqk1b@r.postjobfree.com

650-***-****

My talent for solving cross-functional problems through superior progressive analytical reasoning and innovating abilities has been recognized for each role I have endeavored. I have over 15 years of hands-on experience working with therapeutic proteins, models of cancer biology, cell-based therapy, pathogenic organisms, GMP manufacturing, quality control and business development. My outperformance in all roles, while carrying loads typical of entire departments, is driven by my relentless pursuit of solutions until goals are met or exceeded. With some knowledge of virtually every subject, my ability to generate timely and actionable information is formidable. Where others have tunnel vision, I approach every challenge from multiple perspectives by channeling a lifetime of lessons learned.

Fluent in theory, methods and analysis. Primary resource for information and ideas, director of operations, mentor to junior members, and liaison to executive leadership. Cohesive team leader, project goal consensus builder, efficient asset and resource manager, persuasive yet diplomatic communicator. My unique insight and technical ability will lead to your successful corporate strategy.

PROFESSIONAL EXPERIENCE

Senior Scientist (Sep 2014 to Present)

Cone Bioproducts is a biomedical company focused on developing, manufacturing, and marketing human plasma/serum products which are sold to manufacturers and distributors of end-user in vitro diagnostic products.

As a thought leader, I continuously introduce new technology, infrastructure, and methodology to improve manufacturing, product quality and stability, and regulatory compliance.

Developed methods to purify active proteins/enzymes from tissues/fluids saving the cost of purchasing these analytes.

Installed infrastructure to scale up manufacturing while improving and speeding up sanitization of batch equipment.

Established and implemented bloodborne pathogens training, exposure control plan, and biological waste disposal programs to meet regulatory compliance.

Senior Scientist (Apr 2011-May 2014)

Terapio is a biopharmaceutical company developing therapeutics using the RLIP76 protein as a medical countermeasure for radiation exposure and chemical threats to civilian, military, and first responder populations. RLIP76 works in the oxidative stress pathway and provides benefit as a prophylactic and post exposure treatment.

My background in protein chemistry, cell biology, and microbiology empowered me to take control of this project, persuade executive leadership to abandon a failing dogma, and successfully change direction of the company resulting in numerous victories where a dozen CMO groups had failed before me.

Served as technical and project(s) lead for API isolation, biologic drug production, formulation, and assay development while advancing company to IND-enabling studies through successful process development.

Developed new, commercially viable upstream and downstream purification processes, reduced process time and increased purity, then successfully led technical transfer of entire process, including documentation and procedures, to CMO for scale-up and GLP tox batch production.

Elucidated unique properties of this amphipathic membrane-associated protein enabling a reduction of endotoxin level in final product by 4-logs, formulation optimization leading to an increased solubility of greater than 40-fold, and development of a mechanism of action cell-based activity assay to replace 30-day in vivo activity assay.

Continue to consult on process development issues as this biologic drug moves closer to IND application.

Research Scientist and Laboratory Manager (Jan 2009-Apr 2011)

INCELL is a products manufacturer and contract services biopharmaceutical company registered with the FDA as a manufacturer of sterile liquid fill products and medical devices, and for process and use of human cells.

My broad knowledge of microbiology, biochemistry, cell and molecular biology, as well as engineering mechanical, electrical, and fluid systems, played an integral role in my promotion to Lab Manager during my second month of employment. I assumed full responsibility for running all GMP manufacturing of sterile liquid fill products, quality control and product release testing, and contract research and development while managing the day-to-day activities of all personnel. As the only bench scientist, I independently expanded the company’s capability to increase manufacturing production and acquire new research contracts through ingenuity and innovation.

Developed multiple models for testing various customers’ novel antimicrobial compounds against clinically-isolated pathogens including MRSA, VISA and C. difficile.

Developed method for isolating viable adipose derived mesenchymal stem/progenitor cells from liposuction donor tissue and consulted on the prototypical design of a commercial processing kit for personalized cell-based therapy.

Developed multiple assays to identify customer-specified analytes including immunoassay, cell-based validation assay, ELISA, and colorometric growth assay.

Designed molecular engineering strategy to generate plasmids for transfecting complete signaling system into target cells for bioconversion of pathological compound.

Graduate Student, Teaching Assistant, Postdoctoral Fellow (Aug 2002-Dec 2008)

The University of Texas Health Science Center Graduate School of Biomedical Sciences Department of Cellular and Structural Biology is educating the next generation of cancer researchers to meet the growing demands for scientists trained in multiple facets of cancer biology.

Elucidated tumor/stromal mechanism for transforming growth factor beta (TGFβ)-induced progression in a mouse model of prostate cancer (Verona EV, 2007).

Successfully completed open project that former graduate students and postdoctoral fellows could not by engineering, producing, purifying and characterizing a recombinant fusion protein that strongly inhibits signaling of all three isoforms of TGFβ (Verona EV, 2008). This chimeric receptor is currently being studied pre-clinically as an antimetastatic therapeutic and my work supported a patent issued to the University of Texas (US Patent #7795389).

Developed subcutaneous allograft model of genetically-modified mouse embryonic fibroblasts resulting in tumor-like growths (Kikani CK, Verona EV, et al. 2012).

PREDOCTORAL EXPERIENCE

Research Associate, Genentech, Inc. (Jan 2002-Aug 2002)

Engineered, expressed and purified various soluble TNFα superfamily proteins for binding and structural studies.

Summer Intern, Tularik, Inc. (Jun 2000-Aug 2000)

Engineered, expressed and purified various soluble orphan nuclear receptors for X-ray crystallography and NMR.

Development Associate, Chiron Corporation (Nov 1997-Jan 2000)

Played integral role in process development and scale-up to GMP manufacturing for the expression and purification protocols of tissue factor pathway inhibitor which was used in a Phase III clinical trial for sepsis.

EDUCATION

Ph.D. (2007) Cellular and Structural Biology UT Health Science Center San Antonio, TX

M.S. (2001) Biotechnology University of Texas San Antonio, TX

B.S. (1997) Microbiology University of California Santa Barbara, CA

PROMOTIONS AND AWARDS

(2013) Terapio Corporation: Position elevated to Technical Lead.

(2009) INCELL Corporation: Promoted to Laboratory Manager within two months of employment.

(2007) UTHSCSA: Recognized with the Barbara Bowman Graduate Student of the Year Award.

(2005) UTHSCSA CSB Dept. Retreat: Awarded 1st Place for graduate student research poster.

(1999) Chiron Corporation: Recognized with the Employee Excellence Award.

PEER-REVIEWED PUBLICATIONS AND MANUSCRIPT

1.Kikani CK, Verona EV, et al. Proliferative and antiapoptotic signaling stimulated by nuclear-localized PDK1 results in oncogenesis. Sci Signal. 2012 Nov 6;5(249):ra80.

2.Verona EV, et al. Expression, purification and characterization of BGERII: a novel pan-TGF-beta inhibitor. Protein Eng Des Sel. 2008 Jul;21(7):463-73.

3.Verona EV, et al. Transforming growth factor-beta signaling in prostate stromal cells supports prostate carcinoma growth by up-regulating stromal genes related to tissue remodeling. Cancer Res. 2007 Jun 15;67(12):5737-46.

4.Verona EV, et al. Clinical isolates of multidrug resistant MRSA are highly-susceptible to a novel class of antibacterials. (manuscript in preparation)

TECHNICAL EXPERTISE

Biologic Drug Development: molecular construction, strain development, fermentation, purification, assay development, GMP manufacturing, quality control/product release testing, technology transfer

Business Development: strategic thinker, point of contact, IP protection, negotiation, influencing, persuading, RFP, SOW

Data Analysis: big data sets, tracking, trending, critical interpretation, informatics, statistics, identification of extraneous or deficient information, attention to detail

Documentation: detailed record keeping, data logging, systematic organization, SOP, batch records, SOW, CAPA

Operations Management: infrastructure/capital acquisition and installation, matrix, metrics, Gantt, budget, scheduling, interview/hire/terminate, root-cause-analysis

Physiology: cancer, infection, inflammation, immunology, coagulation, wound healing, pain, oxidative stress

Regulatory: OSHA 29 CFR 1910.1030, 21 CFR 210/211, TCEQ, TAC

Teaching: PhD-level critical reading/interpretation/presentation of scientific literature, basic to complex science concepts/practical skills

Troubleshooting: equipment, procedures, results, mechanical, electrical, and fluid systems

HOBBIES

Construction: woodwork/carpentry, metalwork/welding, concrete/masonry, electrical, plumbing, general fabrication/repair

Culinary Arts: traditional Italian cooking, gardening, making wine, beer, limoncello and grappa

LANGUAGES

Italian – Native Speaker

Spanish – Advanced



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