Medical Device
Resume:
Gregory R. Brotske
New York, NY 10022
********@*****.***
Microbiology lab professional experienced in biological research. Skilled in microbiological assay development, human cell culturing, ELISA, immunofluorescence, and microbiological quality control assessment of pharmaceutical materials.
EXPERIENCE
Teleflex Medical/Semprus Biosciences, Cambridge, MA
Scientist
July 2011 to July 2015
Developed assays for the evaluation of medical device performance (PICC catheters, hemodialysis catheters, contact lenses, endotracheal tubes, and orthopedic materials) against microbial challenge through adhesion and biofilm formation and MIC/MBC
Performed and developed protein detection assays on human dermal fibroblasts and human aortic endothelial cells through ELISA and immunofluroescence
Developed and performed assays to quantitate adhered protein on medical devices using radioactive and fluorescent labels
Through literature review, assisted in the development of clinically relevant assays and animal models to assess device performance
Validated analytical procedures in preparation for 510(k) submission
Authored SOPs and work instructions
Covidien (Contracted through Kelly Scientific Services), Mansfield, MA
Microbiologist
April 2010 to April 2011
Performed microbiological testing of antimicrobial coatings on dialysis catheters and optimized in-house protocols to increase biofilm formation and microbial recovery
Developed preparatory methods simulating clinical use of dialysis catheters
Azopharma Product Development Group, Miramar, FL
Microbiologist
August 2008 to February 2010
Performed compendial microbial testing (bioburden, sterility, antimicrobial effectiveness testing, bacterial endotoxin testing) on raw materials and finished products, according to current USP and EP
Performed microbial identifications using a Vitek 2 Compact
Provided environmental monitoring support for cGMP and commercial manufacturing functions
Revised and initiated microbiological SOPs in compliance with FDA and USP guidelines
Research and method development per client request
KSA Environmental Laboratory, Miramar, FL
Supervisor/Analyst, Volatile Organics
March 2006 to July 2008
Prepared and analyzed environmental water, soil, and air samples according to EPA guidelines (methods 8260B, 624, 524.2, and EPA-18) using GC/MS; interpreted data to be reported to clients
Responsible for training, scheduling, and technical support for two direct reports
Developed specialized analytical methods per client request
Andrx Pharmaceuticals, Davie, FL
Software Analyst
September 2005 to March 2006
Configured LIMS system for use in laboratory data entry, according to cGMP guidelines
Wrote and executed protocols used to test the operational and performance qualifications in development of LIMS system
CT Laboratories, Baraboo, WI
Lab Analyst
August 2002 to August 2005
Analyzed environmental water and soil samples for the presence of volatile organic compounds (using GC/FID, GC/ELCD, GC/MS; EPA Methods 8020, 8015B, 8021, 524.2, and 8260)
Interpreted data and prepared it for remittance to clients
EDUCATION
Master of Science in Psychology, May 2010
University of Phoenix
Bachelor of Science in Biology, May 2002
Saint Norbert College, DePere, Wisconsin
PUBLICATIONS
“Vascular Catheters with a Nonleaching Poly-Sulfobetaine Surface Modification Reduce Thrombus Formation and Microbial Attachment”; Roger S. Smith, Zheng Zhang, Michael Bouchard, Jun Li, Heather S. Lapp, Gregory R. Brotske, David L. Lucchino, Douglas Weaver, Laurence A. Roth, Arthur Coury, John Biggerstaff, Sivaprasad Sukaveneshvar, Robert Langer and Christopher Loose; Science Translational Medicine, 4:153 (September 26, 2012), p. 153
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