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Medical Device

Location:
New York, NY
Posted:
August 04, 2015

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Resume:

Gregory R. Brotske

*** *. **** **. #***

305-***-****

New York, NY 10022

acq23k@r.postjobfree.com

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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