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Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLEPHONE NUMBER AVAILABLESummary:Dedicated and experienced Analytical Scientist with over twenty solid years of experience in quality control testing, analytical testing of pharmaceutical products, drug substances products, nutritional products, and biologics products. Knowledgeable in a broad range of instrumentation including but not limited to SPC, HPLC, GC, NMR, UPLC H-class, chromatogram integration, Elisa, qPCR, and data interpretation plus analytical and report writing skills. Experienced in analytical method development and reverse engineering for suspension and emulsion products. Expert with testing of products to ensure suitability for human consumption. Able to effectively manage multiple projects simultaneously and complete assigned tasks promptly.Work Experience:Zoetis Pharmaceutical Charles City, IAQC Senior Scientist 02/15/2020- Present Experience in pharmaceutical biologics, and sterile manufacture in a QC laboratory setting. Understanding of bioassay test methods (Elisa, Flow cytometry, qPCR, cell culture). I comply with SOPs and GxPs in a consistent and compliant manner. Detail orientated and able to proof work and identify non-standard format or wording, and errors within documents. Problem-solving and supporting colleagues plus ensuring cleanliness of laboratory working areas. I support OOS/OOE/OOT and deviationinvestigations. I follow all GxP quality policies and procedures. Cambrex Pharmaceutical Charles City, IAPSG QC Scientist Chemist II (Contract) 09/08/2018- 12/10/2019 Perform chemical testing using analytical instrumentation including HPLC, and UPLC. GC, Headspace GC, Particle size, Karl Fischer (Coulometric and Volumetric), TOC, LOD, FT-IR, TLC, AA, UV-VIS, NMR and ICAP Working with control drug substances and pharmaceutical products in an FDA manufacturing environment using wet chemistry preparing dilutions and sample preparations Troubleshooting laboratory instrumentation and administering simple repairs as needed Utilized Empower III FR4 software and binder notebook for chromatogram integration and data interpretation plus analytical and report writing skills plus proficiency in Microsoft Excel and Word Performed environmental testing in compliance with state guidelines to maintain certification in the environmental laboratory Complied with cGMP/GLP/GDP/USP/CFR regulations and US FDA/ICH Q7 guidelines and procedures Lab Express Inc Fairfield, NJSenior QC Scientist (Contract) 12/01/2017-08/03/2018 Working with liquids Chlorhexidine Gluconate 20%, pharmaceutical, FDA and manufacturing environment Performed testing using separation techniques involving Alliance HPLC, by Waters e2695, FTIR(Perkin Elmer RX1) TLC, Refractive Index-Brix, Assay by Residue and Specific Gravity Utilized Empower III software and binder notebook for chromatogram integration and data interpretation plus analytical and report writing skills. Performed work with liquids, pharmaceutical, FDA, and manufacturing environment synthesis wet chemistry, dilutions, mobile, and sample preparations Complied with cGMP/GLP/GDP/USP/CFR regulations and OSHA safety regulations reporting all data analysis in a Unicorn LIMS systemRoche Molecular Systems Inc Branchburg, NJSenior Scientist (Contract) 10/25/2016-9/01/2017 Performed studies to characterize key physical and chemical properties of biological materials by DNA/ RNA synthesis Performed testing using separation techniques involving AKTA OligoPilot DNA Synthesizer, UHPLC, and H class UHPLC, by Waters, LC-MS, and UV-VIS analysis Utilized Empower III software and binder notebook for chromatogram integration and data interpretation plus analytical and report writing skills. Performed packing columns for DNA/RNA synthesis wet chemistry, dilutions, mobile and sample preparations Complied with cGMP/GLP/GDP/USP/CFR regulations and OSHA safety regulations reporting all data analysis in a Unicorn LIMS systemSanofi Pasteur Swiftwater, PASenior Scientist II (Contract) 4/25/2016-8/01/2016 Performed studies to characterize key physical and chemical properties of biological materials and formulated vaccine products for Method Validation, Method Development Performed testing using separation techniques involving HPLC, GC, UV-VIS, IR, and pH analysis Utilized Empower II and Empower III software and binder notebook for chromatogram integration and data interpretation plus analytical and report writing skills. Design and execute experiments for the development of test methods such as cell-based assays, ELISA, Biacore, enzymatic assays, and protein characterization methods such as SDS-PAGE, LC-MS, and column chromatography. Performed wet chemistry, dilutions, mobile and sample preparations Complied with cGMP/GLP/GDP/USP/CFR regulations reporting all data analysis in a Labware LIMS systemMerck Pharmaceutical Rahway, NJSenior Associate Scientist (Contract) 8/2015-4/22/2016 Performed studies to characterize key physical and chemical properties of pharmaceutical materials and formulated drug products for Method Validation, Method Development Performed testing using separation techniques involving SPC, HPLC, GC, GC/MS, Utilized Empower II and III software and ELN notebook for chromatogram integration and data interpretation plus deployment of the Empower III software. Performed raw material testing using Specific Rotation, UV-VIS, IR, pH, Titration, Nephlose and wet chemistry Performed wet chemistry, dilutions, mobile and sample preparations Complied with cGMP/GLP/GDP/USP/CFR regulations reporting all data analysis in a LIMS system Air Liquide Morrisville, PAR&D Senior Technician (Contract) 6/2013 - 5/2015 Take part in and/or execute experimental test benches Carry out precise measurements, validation of the experimental results, and participate in their interpretation Uses the principles and theories of science and mathematics to solve problems in R&D Handle maintenance of experimental devices (pH, viscometer, colorimeter, etc.) Participate in improvements, and innovative technical solutions plus manage suppliers and subcontractors Complied with cGMP/USP/CFR/GLP regulations Knowledge of basic computer skills and programs(Word, Excel, PowerPoint)Mars Inc. Hackettstown, NJResearch Analytical Scientist (Contract) 05/2010 - 04/2013 Performed studies to characterize key physical and chemical properties of flavanols and procyanidin oligomers for method development and method validation Performed testing using separation techniques involving HPLC, and GC instrumentation, moisture testing using InfraXact 7500 Foss NIR plus doing physical testing using a texture Analyser and a Viscometer by Brookfield plus reporting all data analysis in a LIMS system Chemstation Software used for quantitative and qualitative collection of analytical techniques Performed testing on peroxide values on AMF and testing on free fatty acids in liquid samples Using a SafTest Analyzer for PeroxySafe, AlkalSafe and FaSafe Performed extractions using solid phase extraction (SPE) plus reporting all data analysis in a LIMS system. Filtered and transferred techniques for the removal of lipid fraction of cocoa powder Complied with cGMP/GLP/GDP/USP/CFR regulationsBecton Dickinson Franklin Lakes, NJResearch Analytical Scientist (Contract) 01/2009 - 02/2010 Performed studies to characterize key physical and chemical properties of pharmaceutical materials and formulated drug products for Method Validation, Method Development Performed testing using separation techniques involving HPLC, GC/MS, LC-MS/MS Utilized Chemstation software and analytical chemistry Performed raw material testing using GC, UV-VIS, IR, pH, TGA, DSC, and wet chemistry Performed assay testing methods using the Sonoclot and Chemwell such methods determining the clotting factor and ELISA method using a 96-well assay plate for Heparin analysis plus Material testing for Extractables and Leachables Complied with cGMP/GLP/GDP/USP/CFR regulations reporting all data analysis in a LIMS system Bracco Analytical Research Princeton, NJResearch Scientist (Contract) 04/2008 - 01/2009 Performed studies to characterize key physical and chemical properties of pharmaceutical material, plus reporting all data analysis in a LIMS system Formulated drug products for method validation and method development Performed testing using separation techniques involving HPLC, GC, TLC, Prep HPLC, LCMS/MS Utilized Chemstation software and analytical chemistry Performed raw material testing using GC, UV-VIS, IR, KF, pH, TGA, DSC, Fiber Optic Oxygen Probe Conductivity, Osmolality, and wet chemistry Performed testing requiring wet chemistry techniques such as Karl Fischer moisture determination and pH determination Performed various calibration procedures to support general laboratory testing such as balance check, Karl Fischer, HPLC, GC, DigiPol Polarimeter and pH meters Complied with cGMP/GLP/GDP/USP/CFR regulationsSchering-Plough Research Institute Summit, NJAssistant Scientist (Contract) 09/2007 - 04/2008 Performed studies to characterize key physical and chemical properties of pharmaceutical materials and formulated drug products for SCH 900776, 900978, and 727965 Method Validation, Method Development Performed testing using separation techniques involving HPLC, GC, TLC, LC-MS Utilized millennium32 software and analytical chemistry Performed testing requiring wet chemistry techniques such as Karl Fischer moisture determination pH determination and Osmolality Trained in various calibration procedures to support general laboratory testing such as balance check, Karl Fischer and pH Complied with cGMP/GLP/GDP/USP/CFR regulationsTeva Pharmaceuticals Fairfield, NJAnalytical Chemist (Contract) 02/2006 - 08/2007 Preparation of analytical solutions required to perform testing for HPLC and GC analyses for stability testing and Method Validation Performed Dissolution, Disintegration, moisture analysis by Karl Fisher, and Disintegration testing plus reporting all data analysis in a LIMS system Responsible for documentation and review of analytical results in validated LIMS system Performed instrumental analysis using HPLC, FTIR Spectrophotometry, and GC on routine finished product, stability, and raw material samples Complied with cGMP/USP/CFR/GLP regulationsEducation:University of North Texas, Denton, TXBachelor of Applied Arts and Sciences (BAAS)Graduation: Spring 2024, GPA 3.1Concentrations:Administration, Business Analytics, and ChemistryOccupational specialization:Biological SciencesSt. Philips College, San Antonio, TXDual Associate Degree in Chemistry & BiologyGraduation: Spring and Fall 1998, GPA 3.2Certifications:Lean Six Sigma Yellow Belt Project,Zoetis Pharmaceutical, Charles City, IA 04/2024DNA Analysis of Mycoplasma HyopneumoniaeChromack Research Inc., Somerville, NJCertificate in Chromatography, 10/2006Health & Technology Professionals, LLC, Nutley, NJ Certification for Hemodialysis Technician, 10/2004 San Antonio College of Medical and Dental Assistant, San Antonio, TX Certification for Registered Medical Assistant (RMA), Graduation: Fall 1994Additional Training:United States Army, based in Texas and Germany;7/1986-7/1989 (Honorable Discharged) |
