Data Collection Medical Device
Resume:
HIGHLIGHTS OF QUALIFICATIONS
●Twenty-one years of maintaining documentation and qualification with a host of federal entities
●Thirteen years of clean room experience working in compliance with ISO 17025 and ISO 9001
●Nine years of experience assisting clients in testing selection and explaining technical data
●Four years of hands-on experience in early drug development and in vitro cell-based assays
●Sixteen years of experience using Microsoft office with accelerated proficiency in Microsoft Excel
●Experience dealing with federal and state regulatory agencies to ensure compliance
●Experience developing validation GLP/GCP data sets and achieving ISO/IEC 17025:2017 accreditation
PROFESSIONAL EXPERIENCE
Medical Device Specialist, Mallinckrodt Pharmaceuticals (May 2024 – Current)
●Assemble and test finished and semi-finished medical devices per established SOP’s
●Document assembly and test data using electronic records systems in par with GCP/GLP/GMP practices
Analytical Chemist II, Eurofins (Apr 2022 – Apr 2024)
●Chemical extraction and purification of over a hundred of biological and artificial compounds
●Chemical formulation for method design by use of HPLC, UPLC, LCMS/MS analysis
●Software Programming to optimize HPLC compound analysis for a host of software
●Gradient calculation and development of compounds qualified for ISO 9001 accreditation
●Calibration and preventative maintenance of HPLC and HPGC systems using MS and FID
●Program Masshunter, Chromeleon, Analyst and NIMS software for data collection and analysis
●SOP modification and review to reflect current GCP/GLP/GMP
●Method adaptation and optimization at customer request to achieve personized data
●Data interpretation and analysis of derived chromatography post method design and analysis
Product Development Scientist, Bell Laboratories (Nov 2021 – Mar 2022)
●Establish mechanisms for traceability and QC to enhance consistent production of rodenticide
●Utilize UPLC/PDA for quality control of active ingredients in company products
●Develop tests to determine mechanic and thermal stability while shipping to climate sensitive areas
●Data interpretation and analysis of derived chromatography post method design
●Programming of Empower and eNOTES software for data collection and analysis
Senior Research Technician, Telic Labs (Jan 2021 – Nov 2021)
●Development of a startup laboratory specializing in safety and compliance of cannabis testing
●Create systems to ensure traceability in compliance with federal and state regulatory entities
●Chemical extraction and purification of biological and artificial compounds
●Chemical formulation for method design by use of HPLC, UPLC, LCMS/MS analysis
●Gradient calculation and development of compounds qualified for ISO 9001 accreditation
●Software Programming to optimize HPLC compound analysis for a host of software
●Utilize HPLC, and RT-PCR for cannabinoid potency and microbial content of Cannabis
●Seek out customers to expand company development and drive income for research expansion
●Instruct customers on analysis specifications and assist customers in understanding results
●Create validation sets to successfully acquire federal ISO 17021 accreditation
●Data interpretation and analysis of derived chromatography post method design
●Programming of LabSolutions, iLIMS, and Excel software for data acquisition and analysis
Research Analyst, Covance (Apr 2018 – Dec 2020)
●Study drugs in early development for toxicity and rate of metabolism
●Chemical extraction and purification of biological and artificial compounds
●Chemical formulation for method design by use of HPLC, UPLC, LCMS/MS analysis
●Gradient calculation and development of compounds qualified for ISO 9001 accreditation
●Software Programming to optimize HPLC compound analysis for a host of software
●Utilize HPLC, and RT-PCR for cannabinoid potency and microbial content of Cannabis
●Utilize LC/MS to detect the presence of molecules after various biological assays
●Modify assay conditions for analysis and optimization of LCMS and HPLC/UPLC conditions
●Data interpretation and analysis of derived chromatography post method design
●Maintain documentation in compliance with GCP/GLP practices
●Programming of Analyst, Laura, and Excel for data acquisition and quantitation analysis
●Identify and document Quality Events using most recent company software
Microscopist, EMSL Analytical (Sep 2015 – Apr 2018)
●Analyze bulk and air samples for the presence of mold and asbestos using phased contrast, and polarized light microscopy using established SOP’s
●Develop and maintain effective communication with customers while educating them on proper sampling methods and test selection to help them acquire appropriate results for their samples
●Utilize iLIMS for data collection in compliance with EPA regulations
Research Assistant, University of Illinois (Oct 2011 – May 2015)
●Culture stem cells under a variety of conditions and performing expression analysis using sectioning, staining, fluorescent microscopy, PCR/SDS-PAGE
●Transplantation of 3D culture systems into animal models to include: IV/IM injections of antibiotics, anesthesia administration and performing liposuction in porcine models
●Anesthesia administration through intubation as well as IM and IV administration of antibiotics
●Employ molecular imaging of cell development using DXA, Micro CT imagery, and Immunofluorescence
Electrical Power Production, United States Air Force Basic Training/Tech School (Dec 2002-Mar 2003) Robins AFB Georgia (Mar 2003 – Jul 2005) Ramstein AB Germany (Jul 2005 – May 2008)
●Train and lead personnel to perform maintenance and repair on electrical distribution and mobile aircraft arresting systems in peacetime and wartime scenarios using established SOP’s
●Write annual performance reviews as well as document and implement disciplinary action
EDUCATION
Eastern Michigan University Ypsilanti, Michigan (Aug 2014 – Apr 2015)
Graduate coursework in Molecular and Cellular Biology including Molecular Genetics
University of Illinois Champaign, Illinois (Aug 2011 – May 2014)
Bachelors of Liberal Arts and Sciences - Molecular and Cellular Biology
PUBLICATIONS
●Wheeler, Matthew & Maki, Aaron & Ercolin, Anna & Cooper, Jamey & Roballo, Kelly & Rubessa, Marcello & Rabel, Chanaka. (2020). Autologous Adipose-Derived Stem Cells, Platelet-Rich Plasma, and Fibrin Enhance Healing of Mandibular Bone Defects in Swine. International Journal of Regenerative Medicine. 1-9. 10.31487/j.RGM.2020.02.01.
●Zopf DA, Flanagan CL, Wheeler M, Hollister SJ, Green GE. Treatment of severe porcine tracheomalacia with a 3-dimensionally printed, bioresorbable, external airway splint. JAMA Otolaryngol Head Neck Surg. 2014 Jan;140(1):66-71. doi: 10.1001/jamaoto.2013.5644. PMID: 24232078; PMCID: PMC4429780.
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