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Click here or scroll down to respond to this candidate|Candidate's Name is James | ||Street Address East 37th Ave.| || |Objective ||Lot #438 |To secure a senior position in analytical Research and ||Hobart, Indiana |Development or laboratory management utilizing my extensive||46342 |experience in chromatography, project management and ||PHONE NUMBER AVAILABLE |supervision. ||EMAIL AVAILABLE | || | || |Employment History || | || |Associate Analytical Scientist || |March 2015 - July 2015 MonoSol Rx Portage, IN. 46368 || |Responsible for analytical test method || |development/validation utilizing || |Waters Alliance HPLC chromatography system with EMPOWER 3 || |as data collection platform. Review and verification || |of of test data generated by colleagues. Contract || |position through Adecco in Hobart, IN. || | || | || | || | || | || |April 2014 - February 2015 Baxter Healthcare Round Lake,|| |IL. 60073 || |Responsible for performing "gap" analysis of analytical || |test method procedures and raw material specifications used|| |by client plants for the production of fluid systems and || |specialty pharmaceutical products. Compared current || |methods to the analytical test method validation and || |identified "gaps" according to current regulatory || |guidelines. Authored and verified reports for || |communication of "gaps" to regulatory team/agencies. || |Independently performed complex laboratory analysis of || |pharmaceutical products, bulk drug substances and raw || |materials using instrumentation such as GC, HPLC, UV/VIS, || |FTIR and NIR with chromatographic data collection/review by|| |EMPOWER software. || |Performed method development/validation experiments to || |supplement current "gaps" identified by gap analysis. || |Authored validation reports and protocols. || |Performed change control utilizing Trackwise 8 system. || |Routinely acted as project leader on multiple projects, || |interacted with clients, reviewed and evaluated data for || |change control to SOP's and analytical test methods. || |Second person verification/review of lab data and || |associated documentation. || |Contract position through Pharmaceutical Products || |Development, Inc. out of Middleton, WI. || | || |Analytical Chemist || |November 2011 - September 2012 Kremers Urban || |Pharmaceuticals, Seymour, IN. 47274 || |QC testing of finished product, drug substance, stability || |samples and raw materials using instrumentation such as || |HPLC, UV/VIS, FTIR and Karl Fischer moisture analysis to || |include dissolution analysis with chromatographic data || |collection/review by Chromeleon software. || |Participated in analytical test method || |development/validation experiments and transfer of || |analytical test methods from Pharmaceutical Technology (PT)|| |to Quality Control (QC).Review and verification of data, || |validation reports and protocols generated by peer || |colleagues for accuracy, completeness, traceability and || |clarity.Contract position with the company. || | || | || | || | || | || | || | || | || | || |Analytical Chemist August 2008 - November 2008 Abbott Labs|| |North Chicago, IL. 60064Responsible for OQ/PQ of HPLC || |instrumentation (Agilent series 1200) with chromatographic || |data collection by Millennium software.Provided analytical || |support to Abbott's Fermentation Group with HPLC analysis || |of fermented batch product using approved analytical || |methodology. || |Review and verification of data, validation reports and || |protocols generated by peer colleagues for accuracy, || |completeness, traceability and clarity. || |Contract position through ManPower Technical out of Gurnee,|| |IL. || |Analytical R & D Chemist || |June 2007 - May 2008; March 2005 - May 2006 Eli Lilly & || |Co. || |West Lafayette, IN. 47906 || |Routine analysis of R&D product development samples using || |approved analytical test methods on Agilent series 1100 || |HPLC with chromatographic data collection/review by EMPOWER|| |software. Also performed various "wet chemistry" tests and|| |spectroscopic analysis on same development samples. Used || |"Smart Lab" electronic notebook to perform and verify daily|| |calibration of analytical instruments such as balances, pH || |meters, Karl Fischer moisture analyzer, etc. Results entry|| |into ADMIN/LIMS database. Second person verification of || |data/calculations, sample and diluent preparations || |generated by peer colleagues || |Participated in analytical method development/validation || |experiments and method transfers between inter-departmental|| |labs. Troubleshoot equipment and test methods when system || |suitability failures arise. || |OQ/PQ experiments to validate newly purchased HPLC || |instrumentation or after major repairs/movement to new || |location of instrumentation. || |Contract position through Volt Technical Services out of || |Indianapolis, IN. || |Quality Control Analytical Chemist || |June 2003 - August 2004 Morton Grove Pharmaceuticals || |Morton Grove, IL. 60053 || |Routine analysis of finished product, stability and || |customer complaint samples for active ingredients and || |degradation impurities using Agilent 1100 series HPLC and || |HP5890 GC with data collection/review by ChemStation || |software. || |Troubleshooting of analytical instrumentation and test || |methods when system suitability failures arise. || |R & D Analytical Chemist || |November 2001 - May 2003 Abbott Labs Abbott Park, IL.|| |60064 || |Toxicology analysis of human and animal tissue, plasma and || |urine samples using HPLC/MS instrumentation by PE SCIEX || |3000 series. Data collection/review was controlled and || |accomplished by software written in-house for MacIntosh || |computers to generate study data. Write and second person || |verify study/protocol reports; second person verify data || |generated by peer colleagues. || |Complete and accurate documentation and archiving of all || |study data. || |Contract position through ManPower Technical within || |Abbott's Drug Safety Evaluation Division. || | || |R & D Analytical Chemist || |September 1997 - December 1999 Abbott Labs North || |Chicago, IL. 60064 || |Responsibilities included method development/validation || |experiments for HPLC analytical test methods to be used for|| |finished product, bulk active ingredients and excipients || |testing. Part of Apomorphine project team. || |Forced degradation studies and subsequent analytical || |testing of finished product, bulk active ingredients and || |excipients as part of NDA submission package utilizing || |approved HPLC analytical test methods. Data collected on || |Waters Alliance 2690 instrumentation with data || |processing/review by TSP 1000 and Millennium software. || |Complete and accurate documentation of all study data. || |Write study reports and protocols. Second person verify || |reports and data generated by peer colleagues. || |Contract position through Lab Support/On Assignment out of || |Des Plains, IL. || | || |Supervisor of Instrumentation Group || |September 1989 - August 1996 Silliker Laboratories || |Chicago Heights, IL. || |Responsible for validating all chromatographic || |instrumentation as well as developing/validating analytical|| |test methods to be used in testing food/beverage products || |for cholesterol, fatty acid profiling, carbohydrate || |profiling, pesticide analysis and mineral content. || |Recruited to help set up chemistry testing laboratory for || |food/beverage analysis. || |Supervised 6-7 chemists operating a wide range of || |instrumentation including GC, AA, ICP and HPLC. || |Maintenance and troubleshooting of instrumentation and || |analytical test methodology. || |Implemented and trained staff to meet company requirements || |in Total Quality Management program. || |Also responsible for client contact regarding sample || |receipt, analysis turnaround time and test pricing. || |Maintained efficiency while promoting accuracy and quality || |of test data reported to client. || | || |Quality Control Analytical Chemist || |April 1986 - August 1989 Erickson Cosmetics Co. || |Chicago, IL. || |Responsible for analyzing incoming raw materials, finished || |product and stability samples using approved analytical || |test methodology by GC and HPLC. Developed and validated || |analytical test methods for OTC drug analytes using HPLC || |and GC chromatography. Troubleshoot test methods and || |instrumentation if a problem developed. In-process || |analysis of finished OTC product in order to make batch || |corrections if necessary. || | || | || | || | || |Education || |September 1974 - May 1980 Michigan Technological || |University Houghton, MI. 49931 || |Bachelor of Science in Chemistry, B.S. Degree received May || |1980 || |Minor in Physics and Math || |Other Experience || |I have thirty years of experience in analytical chemistry || |as a chromatographer (HPLC, GC, GC/MS and HPLC/MS). I have|| |worked with a wide variety of matrices from cosmetics to || |food/beverage, pharmaceutical products and API drug || |substances including animal/human tissue, plasma and blood || |for toxicology analysis. I have developed/validated || |analytical test methods for instrumentation such as HPLC, || |GC, AA, ICP, FTIR, NIR and UV/VIS. I have extensive || |knowledge of FDA regulations and compendium such as USP, || |EP, BP, JP, AOAC and the Food Chemical Codex. || |References || |References are available on request. | |
