Design Engineering
Resume:
KIMBERLY KENTNER
********.*******@*****.***
**** ******* ***, *********, ** 21230
Education
The Johns Hopkins University, Krieger School of Arts and Sciences Expected
Graduation:
M.S. Regulatory Science August 2014
GPA: 4.0
University of Pittsburgh, Swanson School of Engineering GPA: 3.65
B.S. Bioengineering, April 2012 Dean’s list all semesters
Concentration: Cellular and Medical Product Engineering
Minor: Chemistry
Relevant Skills
Regulations: cGMP compliance, 21CFR 820
Programs/languages: Microsoft Office, Minitab, EndNote, Excel, SolidWorks, HTML, Matlab, C++, Unix, ImageJ
Lab skills: Cell Culture, ELISA, PCR, RNAi, Histochemical staining, Western blotting, DSC, Instron mechanical testing
Relevant Coursework
“QSR Compliance Basics: Complying with the FDA's Medical Device 21 CFR 820 Quality System Regulation”
EduQuest, Frederick, MD April 30-May 1, 2013
Introduction to cGMP Compliance, Translational Biotechnology: From Intellectual Property to Licensing, Introduction to
Regulatory Affairs, Biological Processes in Regulatory Affairs, Food and Drug Law, Clinical Development of Drugs and
Biologics, Senior Design 1 & 2, Human Factors Engineering
Work Experience
ACell Inc. Product Development Engineer, Columbia, MD July 2012-Present
• Team leader of multidisciplinary team providing complete design history file revamp for two marketed products.
• In charge of design verification, design validation, implementation of design controls and document control
preparation and execution.
• Responsible for design verification testing including mechanical strength, onset temperature, hydration, suture
compatibility, and endotoxin testing.
• Head of design validation team for multiple products, including study design, GLP lab communications, and
protocol and report writing.
• Sterilization validation dose mapping for urinary bladder matrix (UBM) powder products per ISO11137.
• Temperature control studies using DSC to examine effect of temperature and humidity on the storage of UBM
products.
• Assisted in letter to file generation for analysis of changes to existing medical products including gap analysis.
Co-Principal Investigator: National Space Biomedical Research Institute (NSBRI) SMARTCAP Award
(NASA NCC 9-58).
• In charge of the development and characterization of a novel UBM gel appropriate for space application.
• Animal model development for a rat ischemic wound healing model for gel feasibility testing.
• Original packaging research, design, and implementation through work with outside vendor.
• Responsible for preliminary manufacture and sterilization of final UBM gel.
• Research into design transfer to manufacturing for UBM gel including syringe filling testing.
• In charge of communication with NSBRI regarding project goals and progress.
• http://www.youtube.com/watch?v=B6y9bAeNU9o
ACell Inc. Research and Development Intern, Columbia, MD May 2011-August 2011
• Characterization of the growth factor, DNA, and glycosaminoglycan content of MatriStem UBM products.
• Responsible for setting up the research lab facility through contact with outside vendors.
Academic Support Services for Student-Athletes, Pittsburgh, PA Fall 2010-April
2012
• Tutor for student athletes in math and science
Undergraduate Teaching Assistant: Organic Chemistry II lab, University of Pittsburgh Spring 2011
Undergraduate Research Experience Jan. 2010-May 2012
Dr. Lewis Jacobson, University of Pittsburgh
• Studied PP2A phosphatase activity involved in the muscle protein degradation insulin signaling pathway using
Caenorhabditis elegans as a model organism.
• Responsible for training of new undergraduate researchers.
Awards and Accomplishments
• University of Pittsburgh Chancellor's Undergraduate Research Fellowship Fall 2011
• University of Pittsburgh Honors Research Apprenticeship Spring 2011
International Experience
University of Pittsburgh Plus 3 program: Germany May-Sept. 2009
• Two weeks in Germany integrating culture, engineering, and business principles culminating in a paper and
presentation on a German brewery.
Activities
Regulatory Affairs Professionals Society (RAPS) April 2013-Present
University of Pittsburgh Biomedical Engineering Society (BMES) Sept.2009-April 2012
• Vice President (March 2011-April 2012)
• Secretary (April 2010-March 2011)
Pittsburgh Association for Leadership and Success (PALS) Oct. 2008-April 2012
• Cofounding member
• Worked with other students and organizations to make relevant changes on the Pittsburgh campus
Abstracts and Posters
Kentner, K.A., K. A. Stuart, K. Lam, C. A. Koeller, D. Ochoa, R. Patton, T. Laufenberg, C. Lewis, P. Attar, A. D.
Janis. “Development of a Refined Ischemic Wound Model with Intrinsic Controls” 2013 Wound Healing Society Spring
Symposium, Denver, CO, May 2013.
Kentner, K.A., K. A. Stuart, K. Lam, C. A. Koeller, D. Ochoa, R. Patton, T. Laufenberg, C. Lewis, P. Attar, A. D.
Janis. “Anatomical Effects in the Development of a Delayed Wound Healing Model” 2013 Society for Biomaterials Spring
Symposium, Boston, MA, April 2013
Kentner, K.A., K.A. Stuart, A. D. Janis. “Development of a Regenerative Wound Dressing for Improved Healing in
Space” 2013 Human Research Program Investigators’ Workshop, Galveston, TX, February 2013.
Kentner, K.A., K.A. Stuart, A. D. Janis. “Differential Release of Growth Factors from MatriStem® Urinary Bladder
Matrix (UBM) Products” Society for Biomaterials Fall Symposium, New Orleans, LA, October, 2012
Phipps, A. Stuart, K., Kentner, K., Kibalo, B., Janis, A. “Tunable Mechanical, Structural, and Biological Properties of
Urinary Bladder Matrix (UBM) Biomaterials” 2012 Biomedical Engineering Society Annual Meeting, Atlanta, GA.
October 2012.
Kentner, K.A., A.D. Janis. “Quantification of FGF-2, VEGF, & GAGs in MatriStem® MicroMatrix UBM Biomaterial”
2011 Biomedical Engineering Society Annual Meeting, Hartford, CT, October 2011.
Kentner, K.A., L.A. Jacobson. “Regulation of Protein Degradation by a Protein Phosphatase Complex” University
Honors College Undergraduate Research Fair. University of Pittsburgh, Pittsburgh, PA, Spring 2011, 2012
Professional references available upon request
Contact this candidate