Nick Simons Email and Phone Number
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Senior level Analytical Chemist specializing in chromatographic method development/transfer and broad spectrum instrument analysis (LC/MS, GC, SPE, Capillary electrophoresis, Atomic Absorption, UV-Vis, FTIR, ICP, Inherent viscosity) Focused training and troubleshooting experience in LC/MS/MS and GC analysisExperience in early clinical and NPI product development with a focus on API products. Intimate knowledge of ICH guidelines related to development of new APIs including impurity regulations (PGI, etc.), quality standers, and manufacturing practices. Extensive experience in pharmaceutical API and Medical Device quality control control. Experience efficiently managing Raw Material QA department in a internationally recognized ISO 13485, FDA, and cGMP compliant medical device laboratory supporting manufacture of multiple wound care devices, including 70% of worlds absorbable suture.Understanding of Quality Systems, IQ/OQ/PQ validation, and document control systems Specialties: Chromatographic AnalysisAnalytical Method DevelopmentAnalytical Method TransferICH/GMP regulationsDEA Controlled substance regulations
Noramco™
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Senior Technical Service SpecialistNoramco™ Jul 2022 - PresentWilmington, De, UsProvide customer technical support for all aspects of API production, validation, quality, and regulatory. -
Senior Analytical Scientist-R&DPurisys Jul 2019 - Jul 2022Athens, Georgia, Us -
Analytical Scientist-R&DPurisys Jul 2018 - Jul 2019Athens, Georgia, Us -
ChemistThe Janssen Pharmaceutical Companies Of Johnson & Johnson Jan 2014 - Jul 2018Raritan, New Jersey, Us• Primary responsibility is to coordinate in-process testing/ data review to insure Just In Time flow.• Perform lab event investigations to determine root cause and implement corrective/preventive actions through PR and CAPA system. • Function as a lab lead and a SME in analytical instrumentation.• Work with Technical Specialist and vendor Service Engineers to perform instrument validation, IQ/OQ/PQ, and troubleshooting. • Research/ apply new technologies (i.e. NIR, Raman) to reduce turn around times and increase lab efficiency. -
Senior Chemical AnalystEthicon, Inc., A Johnson & Johnson Company Feb 2011 - Jan 2014New Brunswick, Nj, Us• Manage analytical testing lab for raw materials and production polymer. Worked with process engineers to troubleshoot process problems and drive Continuous Improvement through Six Sigma/Kiazen principles. • Manage Non-Conformance Records (NCR) for product testing failures. Work jointly with PE and QE departments to indentify failure root cause, set statistical bounding, and implement corrective actions.• Worked directly with SQM to monitor and maintain outside raw material vendor quality.• Responsible for everyday operation and troubleshooting of multiple analytical instruments including Perkin Elmer AAnalyst 300 AA, Agilent 6890 GC, and Agilent 1100 LC. • Subject Matter Expert and Certified On-the-Job Trainer for analytical testing including GC, LC, Atomic Absorption (AA), FTIR, UV-VIS, and automated viscometer instrumentation. • Successfully trained 7 chemical analysts in testing and instrument analysis for Cornelia location and secondary plant build project in Athens, GA.• In-Depth work with FDA mandated systems including SOP Document Change Control, GMP, and Quality Systems/Non-Conformance management..• Work jointly with QE to perform internal audits and prep for FDA and other external regulatory audits. • Experience with instrument IQ/OQ/PQ and Test Method Validation. -
Licensed Insurance AgentCombined/Agla Insurance Sep 2009 - Apr 2010
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Manufacturing ChemistGeorgia Mountain Biofuels Apr 2008 - Dec 2008Joined new venture company as scientific subject matter expert for the production of biodiesel from oils and animal tallow.Designed 1,500 gal/batch manufacturing process for multi-feedstock conversion to automotive grade biodiesel.Set up and managed quality testing lab for pre-shipment certification of biodiesel batches.
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Chemistry TeacherStephens County High School Aug 2006 - May 2008Taught Chemistry and Physical ScienceFaculty advisor for Science Olympiad
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Research Chemist, Orise FellowCenters For Disease Control And Prevention May 2003 - May 2006Atlanta, Ga, UsResearched under 3 year fellowship from Oak Ridge Institute for Science and Education in the Clinical Chemistry Branch of the National Center for Environmental HealthPart of 2 person team that developed an analytical method to simultaneously detect background levels of multi-class antibiotics in human blood samples.Analytical method consisted of automated Solid Phase Extraction (SPE) cleanup followed by LC-MS/MS analysis.
Nick Simons Skills
Nick Simons Education Details
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Georgia State UniversityChemistry
Frequently Asked Questions about Nick Simons
What company does Nick Simons work for?
Nick Simons works for Noramco™
What is Nick Simons's role at the current company?
Nick Simons's current role is Analytical Chemist specializing in early stage clinical to commercial API method development and validation..
What is Nick Simons's email address?
Nick Simons's email address is ni****@****ail.com
What schools did Nick Simons attend?
Nick Simons attended Georgia State University.
What skills is Nick Simons known for?
Nick Simons has skills like Gas Chromatography, Gmp, Fda, Chromatography, Analytical Chemistry, Medical Devices, Lc Ms, Hplc, Lims, Quality System, Method Development, Training.
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