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Shawn Paul Kraft 7056 19th
ave.N.E.
Seattle,WA 98115
Email: shawn.kraft@gmail.com
Cell: (954) 937-1404
OBJECTIVE: Scientistinthe Biopharmaceutical Industry
SUMMARY: 10 Years of GMP Laboratory Experience as a Bench Chemist
1 Year of Undergraduate Research in Pharmacology (Heath Sciences – UW)
Bachelor of Science in Biochemistry (2005) from University of Washington (Seattle)
EXPERIENCE:
Associate Scientist(AR&D),June 2008 to June 2015
Catalent Pharma Solutions(Somerset,NJ)
 Extensive experience instabilitytestingincludingAssay/RS,CU,Dissolution, andKFfora varietyof drug products
 HighlyproficientinusingAgilentHPLCs,UV Spectrophotometer,Dissolutionw/Autosampler, andKarl Fischer
 ProficientwithTotalchromSoftware for dataacquisition,processing,and reporting
 Some Experience inMethodValidation performingAccuracy/Linearity,Specificity,andRobustness
 Skilledintechnical writingusingthe Trackwise systemforPRwritingincludinglaboratoryinvestigations,OOS/OOTs,
deviations,aberrant/atypical observations,andimpactassessments.
QC ChemistII, June 2006 to February2008
Aveva Drug DeliverySystems(Miramar, FL)
 Carriedoutstabilitytestingontransdermal pharmaceutical products (Assay/RS,CU,Dissolution)
 UtilizedAgilentandWatersHPLCs,AgilentGC,andDissolution(Apparatus6and7) for testing
 Workedon flux studieswith cadaverskinandswabsample analysisforcleaningverification
 DevelopedproficiencyusingMillenium/EmpowerSoftware fordataacquisition,processing,and reporting
ValidationTechnician,August 2005 to May 2006
Andrx-WatsonPharmaceuticals(Davie,FL)
 Executedcleaningvalidationprotocolsand verificationstudiesformanufacturingequipmentusedinthe processing
of variousdrugproductsand performedswabsamplingprocedure onall equipment
 DevelopedproficiencyusingMicrosoftVisioincreatingswabbinglocationdiagramsforall equipment
 Assistedmanagementandconsultants withthe revisionof cleaningSOPsandthe review of IQ,OQ,and PQ
documentationforequipmentvalidationtoidentify qualifiedranges andanyOOS/OOTcases
Research Technician,January 2001 to December2001
Chavkin Lab @ Health Sciences– UniversityofWashington(Seattle,WA)
 Gainedlaboratoryexperienceworkinginaresearchlab assisting graduate studentsandpostdocs
 Performedminorsurgerieson knock-outmice andcarried outelectrophysiologyanalyseson hippocampalbrain
tissue samplesaspartof elucidatingthe molecularmechanismsof opiate analgesictolerance
EDUCATION: UniversityofWashington(Seattle,WA)
Bachelor of Science,BS Biochemistry, 2005
LANGUAGES: English(fluent),German(fluent),French(beginner),Spanish(beginner)

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Scientist

  • 1. Shawn Paul Kraft 7056 19th ave.N.E. Seattle,WA 98115 Email: shawn.kraft@gmail.com Cell: (954) 937-1404 OBJECTIVE: Scientistinthe Biopharmaceutical Industry SUMMARY: 10 Years of GMP Laboratory Experience as a Bench Chemist 1 Year of Undergraduate Research in Pharmacology (Heath Sciences – UW) Bachelor of Science in Biochemistry (2005) from University of Washington (Seattle) EXPERIENCE: Associate Scientist(AR&D),June 2008 to June 2015 Catalent Pharma Solutions(Somerset,NJ)  Extensive experience instabilitytestingincludingAssay/RS,CU,Dissolution, andKFfora varietyof drug products  HighlyproficientinusingAgilentHPLCs,UV Spectrophotometer,Dissolutionw/Autosampler, andKarl Fischer  ProficientwithTotalchromSoftware for dataacquisition,processing,and reporting  Some Experience inMethodValidation performingAccuracy/Linearity,Specificity,andRobustness  Skilledintechnical writingusingthe Trackwise systemforPRwritingincludinglaboratoryinvestigations,OOS/OOTs, deviations,aberrant/atypical observations,andimpactassessments. QC ChemistII, June 2006 to February2008 Aveva Drug DeliverySystems(Miramar, FL)  Carriedoutstabilitytestingontransdermal pharmaceutical products (Assay/RS,CU,Dissolution)  UtilizedAgilentandWatersHPLCs,AgilentGC,andDissolution(Apparatus6and7) for testing  Workedon flux studieswith cadaverskinandswabsample analysisforcleaningverification  DevelopedproficiencyusingMillenium/EmpowerSoftware fordataacquisition,processing,and reporting ValidationTechnician,August 2005 to May 2006 Andrx-WatsonPharmaceuticals(Davie,FL)  Executedcleaningvalidationprotocolsand verificationstudiesformanufacturingequipmentusedinthe processing of variousdrugproductsand performedswabsamplingprocedure onall equipment  DevelopedproficiencyusingMicrosoftVisioincreatingswabbinglocationdiagramsforall equipment  Assistedmanagementandconsultants withthe revisionof cleaningSOPsandthe review of IQ,OQ,and PQ documentationforequipmentvalidationtoidentify qualifiedranges andanyOOS/OOTcases Research Technician,January 2001 to December2001 Chavkin Lab @ Health Sciences– UniversityofWashington(Seattle,WA)  Gainedlaboratoryexperienceworkinginaresearchlab assisting graduate studentsandpostdocs  Performedminorsurgerieson knock-outmice andcarried outelectrophysiologyanalyseson hippocampalbrain tissue samplesaspartof elucidatingthe molecularmechanismsof opiate analgesictolerance EDUCATION: UniversityofWashington(Seattle,WA) Bachelor of Science,BS Biochemistry, 2005 LANGUAGES: English(fluent),German(fluent),French(beginner),Spanish(beginner)