1. 1
RJ Cook
3440 Edison Street
San Mateo, CA 94403
eaglespur1@gmail.com
Mobile:610-360-6717
Summary of Qualifications:
 TwentyEight yearsof experience inmolecularbiology,proteinchemistry,biotechnology
sciences,QCmanagement,RegulatoryAffairs,andQualityAssurance.
 Experiencedinestablishinganddirectinggroups,projectmanagement,assaydevelopment,
personnel trainingand supervision,qualitycontrol,andregulatorycGMPs.
 Thiscombinationof skillsaffordsaunique opportunitytoguide the QualityDepartmentwiththe
knowledge of whatisrequiredfromGMPcompliance andRegulatoryagencies.
 The three differentskill sets of QualityControl,QualityAssurance,andRegulatoryAffairscome
togethertobringabout a well-roundedscientificandcompliance backgroundthatestablishes
soliddecisionmakingandforethoughtinthe discipline of the Qualitydepartment.
Professional Experience
Mylan
Bangalore, India
Contract consultingposition
Regarding GMPQA consult and advisor JUN2O15 – JUL2015
Reviewingmanufacturingand packaging records.
Oversightof deviations and deviationinvestigations,aswell as, documentation.
This is a contract consultancy contracted through Mylan to Quantic and then subcontractedto me
through Quantic to CookConsultingServices.
Exelixis,Inc.,South San Francisco, CA AUG 2013 – NOV 2014
SeniorManager; GMP QualityAssurance

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RecruitedtoExelixisasthe SeniorManagerand QA Lead forcommercial products. Reviewingbatch
records,stabilitydata,validationprotocols,andSOP’sforthe release of commercial drugproducttothe
market.
GMPQuality Assurance:
 Release of commercial drug(Comtriq/Cabozantinib) producttothe approvedmarket.
 Managing the Commercial DrugProductRelease Tracker
 Managing the Lot GenealogyTracker
 Instrumental inlaunchingapprovedproduct (Comtriq/Cabozantinib) tothe EuropeanMarket
 Auditingof contractmanufacturer’sfacilities
 Monitoringthe manufacturingprocess
 Maintainingtransparentandopencommunicationprocesswithcontractmanufacturers
 MonitorDeviationMetrics
 UpdatingQualityTechnical Agreements
 ImplementingTemperatureExcursionNotificationprocess
 Release of Clinical Product(s)tothe Clinical Studies
 Outstanding Accomplishment:Releaseof commercial drugproducttothe market.
Contributingtothe launchof approveddrugproduct to the EuropeanMarket.Establishing
DeviationsMetricsMonitoringprocess.
Owner of private businessmarketinginsurance and financial securities 2011 – Present
 Marketing insurance policiesand group benefitsinsurance forAflac
Covance,Greenfield,IN 2010 - 2013
Head, Global GMPQuality Assurance and Regulatory Affairs

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RecruitedtoCovance forthe leadershipof the global GMPQA team, taskedwithQA oversightand
implementationof all GMP QualitySystemsforCovance. Ensuredorganizationalawarenessof all
applicable international regulationspertainingtoourGMP activities,anddefinedQualitySystem
elementstoaddressthese regulatoryrequirements.Managerialresponsibilityforthe Global GMPQA
teamconsistingof a total of 6 siteswith7 reportsat eachsite fora total responsibilityof 42 reports.Line
managementresponsibilityforimplementingharmonizedGMPQualitySystemsacrossglobal,regional
and local staff & sites.
GMPQuality Assurance:
 Global teammanagement;workedcloselywithteamtoimplementandidentifyandleadprocess
improvementopportunitiesandharmonizationeffortstopromote bestpractices.
 WorkedwithQualityControl Biologicstofacilitate thatdepartments GMPcompliance
 Identified,definedandoversawthe operationof necessaryGMPQualitySystem(QS) elementsto
achieve andmaintainglobal cGMPcompliance byimplementingTrackWise asGMP monitoringtool
 Act as the managementrepresentative forthe global GMPQualityManagementSystem,ensuring
the maintenance of appropriate metrics,datatrending,andprovisionof datainputto management
reviews,withaviewtocontinuousimprovementandenhancementof GMPQS performance
 Control (maintainanddistribute) technical andqualityagreementspertainingtoGlobal GMP
activities
 Ensuredthat the requiredreviewandapproval of GMP recordsby GMP QA staff isconductedin
accordance withthe provisionsof the applicable SponsorQualityAgreements,andcGMPs
 Provides leadership,guidance andoversighttothe auditingstaff.Provideseffectiveguidance to
individualstaff membersforprofessional andpersonal developmentandplayedaleadrole inthe
hostingof clientandregulatorycGMP inspections
 ImplementedSOPand practicesforhandlingauditsandinspections
 Outstanding Accomplishment: Wasable to establishahostingaudit/inspectionprocessthat
resultedinmajorcontractagreementbetweenclientandCovance forthe life cycle of the
productwhichin total isworth approximately$4,000,000,000.00.
Regulatory:
 Monitored,reviewed,wrote regulatorysubmissiondocumentsasrequiredbythe clientsand
regulatoryagencies,suchCTD’s

4. 4
 Oversawtimelysubmissionof regulatorydocumentsforall global sites
 Interactedwithotherexternal QA orregulatoryagenciestoensure alignmentwithcurrentindustry
trends
Sanofi Aventis,Bridgewater,NJ 2002 – 2010
US Quality & Compliance-GMP
SeniorManager movedintothisrole afterGlobal RegulatoryAffairsCMCProjectTeamLeader
 Provide GMPauditingexpertise forthe company'sinternal andexternal biotechcollaborations&
projects,includingGMPcompliance forfacilities(HAVC &BuildingMaintenance systems),
manufacturing,purification,sterile fillingandqualityrelease testing
 Site windowpersonforpilotplanttoensure compliance withall GMP’s. Duringthattenorpilot
plantwas inspected3timesbythe EU forlicensingapproval.Alltimesthe pilotplantwasapproved
 Instrumental forimplementingTrackWise asa GMP compliance monitoringtool
 GMP auditingof vendorsandinternal departments.Aswell as,writingauditreports,also,Pre-PAI
inspectionsof variousinternal andexternal sites.Auditing,managing,anddesignof mediafillsfor
partnersat vendorsites
 Due Diligence effortsevaluatingpotential biotechnologypartneringcompaniesfromaQuality
Assurance perspective includingall biotechnologycapabilitiesfromQualityAssurance,
manufacturing,purification,sterile fillingoperations,andraw materials.
 Reviewof SOP's,InvestigationReports,ValidationReports,andDeviationReportsReviewand
release of batchrecordsfor developmentproducts(includingdeviations,OOS,anddiscrepancies)
 Extensive knowledgeandtraininginIHCGuidelinesasapplicabletomultiple submissionsfor
multiple products
 WritingTechnical/QualityagreementsthatgovernQualityactivitiesandresponsibilitiesbetweenour
companyand our vendorsorour partners
 Outstanding Accomplishment:ProvidingGMPcompliance advice andguidance toour
biotechpartnersandcollaborators. Window site personresponsible forGMPcompliance
for the pilotplant.
AventisPharmaceuticals,Bridgewater, NJ 1999 - 2002
Global Drug Regulatory Affairs

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Global ProjectLeader recruitedtopositionthroughprofessional colleaguebecause of mybiotech
background
Global ProjectLeaderinGlobal Drug RegulatoryAffairs, CMCfor approval of 14 differentinsulin);
includingworldwide approval forthe insulinproductLANTUS
Duties:
 Global Focal Pointfor4 Major MarketedProducts(LANTUS,Insulinhuman;Pancreatin;&Polygeline)
 Responsibilitiestocoordinatedandincorporate multinational andmultifunctionalinputforvarious
productsand projectsandcoordinate regulatoryissuesfornew products
 Auditingof contractmanufacturingfacilities
 Reviewof contractorregulatorydocumentation(batchrecords,SOP's,deviation reports,
developmenthistoryreports,etc.)
 Reviewof IND'sandIND BriefingDocumentsandSupportive workforBLA preparation
 Experience withreviewandsubmissionof regulatorydocumentstothe EMEA, (Committee on
ProprietaryMedicinal Products)CPMP,Ministryof Health,LaborandWelfare (MHLW) of Japan
 Outstanding Accomplishment:Global Focal Pointandleaderforthe global approval of
LANTUS,a recombinantinsulinproductthatbecame acommercial blockbuster.
Medarex,Inc. Annandale,NJ 1996 - 1999
Assistant Director, Head ofQuality Control recruitedtopositionthroughprofessional colleagues
Directingandmanagingthe ProteinChemistryGroup, Immunobiology,Microbiology/Environmental
Monitoring,FlowCytometry,RawMaterial Testing,Shipping&Receiving,andProductStabilityTesting.
Managed a staff of 30
 Dutiesinclude finalapproval onall QCtestresultsinvolvingraw materials,unprocessed bulk,
formulatedbulkandfinal containerpriortoclinical productrelease also,responsible fortrend
analysis,assayvalidationinvolvingIQ's,OQ's,andPQ's

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 Responsibleforall QCdata involvingmicrobiologytestingandenvironmental monitoring,including
asepticfilling,includingmanaging,monitoringandinterpretingdatafrommediafills
 Responsible forall aspectsof Microbiology/Environmental Monitoring,includingmonitoringof
Micro Lab, ManufacturingSuites,PurificationSuites,Sterile FillingSuites,andpersonnel.Also
responsible forMicrobiological testinof in-processandfinal containerof the productand integral
part of approvingthe final rawmaterial specifications.Accountable fortestingandreleaseof all QC
data concerningthe clinical trials
 Co-chair,withQualityAssurance,the approval of the productCertificate of Analysis
 Overall responsibilityforassistingthe OperationsUnittostay inCGMP compliance.Write analytical
reportsthat supportCMC filingsof ourINDfor both the BritishCTXand the U.S. FDA.Responsible
for all ProductCharacterizationtosupportBLA filingsand responsible forconductingandwritingall
BioequivalencyReportssubmittedtoFDA insupportof clonal changesincell culture
 Outstanding Accomplishment:Finalizingthe QCDepartment,establishingthe
Microbiology/Environmental Monitoringdepartment,andco-chairwithQualityAssurance
departmentforthe approval productCertificate of Analysisandclinicalrelease of drug
product.
RegeneronPharmaceuticals,Inc. Tarrytown, NY 1992 -1996
Manager, Quality Control recruitedtothispositionbyprofessional colleague
Responsible fordesigning,implementing,anddirectingthe QualityControldepartmentwhichincluded
the followinggroups:QCProteinChemistry,QCMolecularBiology,QCRaw Material Testing,QC
BioassayandMicrobiology/EnvironmentalMonitoring. ManagedtwoQualityControl Departmentin
differentcitieswithastaff of 25 reports
 Built,setuplab,hiredand managedpersonnel.Integraltomanagingteamforvalidatingof assays,
buildingsystems,HVAC(workedcloselywithoperationsdepartmenttoensure thatHVACsystem
performedpropernumberof airexchangedtominimize microbial andparticulatecontamination
 Responsible forProductCharacterizationtosupportBLA filing
 ImplementedCGMP's.Incharge of assayvalidationprotocols.Review andapproval of analytical
data usedinmeetingproductspecificationcriteria.
 ResponsiblefordeterminingIn-ProcessandFinal ContainerSpecificationsof productforrelease
 Responsibleforanalyzingandapproval of resultsfromRP-HPLC,SDS-PAGE,Westerns,Tryptic
Mapping,N-Terminal Sequencing,LAL,DNA,IEF,Total Protein,AminoAcidAnalysis,Bioassay,USP
chemical monographs,TOC,andInductivelyCoupledPlasmaSpectrometrytests,andMicrobiology

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testresults.Writing,review,andapproval of SOP'sandprotocolsandReview andapproval of
validationprotocolsforFermentationDevelopmentandProcessDevelopment.Directinteraction
and communicationwiththe FDA.
 Responsible forall aspectsof Microbiology/Environmental Monitoring,includingmonitoringof
Micro Lab, ManufacturingSuites,PurificationSuites,Sterile FillingSuites,andpersonnel.Also
responsible forMicrobiological testinof in-processandfinal containerof the product
 Certifiedradiationsafetyofficer.RSOforRegeneronRensselearfacilityandone of the keypersonnel
preparingapplicationlicense forpossessionanduse of radioactive isotopesforRegeneron
 Servedonthe followingcommittees:ValidationTaskForce,ProteinChemistry,Product
Stability/Formulations,President'sCNTFStaff,andUnitFunctionsGroup
 Responsible forReturnedGoodstestingprogram.IdentitytestingprogramandTreatmentstudy
sample analysis
 Outstanding Accomplishment:Establishmentof QualityControl Department.
Synergen,Inc. Boulder,Colorado 1991- 1992
SeniorResearch Associate
 Developedandimplementedthreeseparate DNA hybridizationassaystoanalyze final products,
withsensitivitiesof lessthan0.5pgDNA/mg protein
 Developedobjectiveandquantitative DNA analysisusingPhosphorImage withImage Quant
software.Wrote SOP'sforDNA hybridizationassays.Assayturnaroundtimewasconsistentlyless
than one week
 Oversawroutine analysisof DNA assayand fourtechnicians
 Wrote and directedvalidationprotocolsforDNA hybridizationassay
Somatogen Boulder,Colorado 1989 – 1991
Quality Control Supervisor/SeniorResearchAssociate recruitedtopositionbyprofessionalcolleague

8. 8
Designed,established,andsupervisedthe QualityControl Laboratory.Instrumental inthe designand
implementationof the DocumentationControl Department
 Wrote and implementedamajorityof QCSOP's.Hired,trained,managed,andevaluatedthe
performance of sevenanalytical techniciansalsoestablishedinternshipprogram.Supervisedand
trainedinternsinanalytical techniques
 Implementedthe utilizationof CGMP's.Reviewedandapprovedanalytical dataformeetingproduct
specificationcriteriaasappliedtohumanrecombinantHemoglobin.Asprojectleaderof validation,
wrote,performed,supervised,andreviewedvalidationprotocols.Designedanddirectedprojects
and experiments.Wrote monthlyoperationandprogressreportsforupper-levelmanagement
 Collaboratedinthe developmentof the Analytical ProteinChemistryLaboratory.Developed
analytical techniquesandassaystosupportthe Analytical ChemistryGroup
 Small BusinessInvestigative Researchtodevelopandmarketnucleicacidhybridizationmethodsand
detection.Developmentof "WorkingPaper" toestablishvalidationdatatopresenttothe FDA
 OriginatedandDevelopedthe WesternCapillaryTransferBlotforIsoElectricFocusing(IEF)
 Servedonthe followingcommittees:DocumentationControl Committee,Radioisotope Committee,
and Internal ManagementTrainingProgram.
 Developedobjectiveandquantitative DNA analysisusingPhosphorImage withImage Quant
software.Wrote SOP'sforDNA hybridizationassays.Assayturnaroundtimewas
consistentlylessthanone week
 Oversawroutine analysisof DNA assayand fourtechnicians
 Wrote and directedvalidationprotocolsforDNA hybridizationassay
 Outstanding Accomplishment:Establishingentire QualityControl Department.
Invitron St. Louis, Missouri 1988 - 1989
SeniorResearch Associate (ProteinChemistry& MolecularBiology)
Assistedinthe developmentandimplementationof analytical techniquesforthe Cell CultureMethods
DevelopmentGroup.Includingthe utilizationof sterile techniquesasapplicabletomammaliancell
cultures

9. 9
 Responsible forperforminganalytical methodsinsupportof cell line evaluationsandformal
expressionexperiments
 Participatedinthe evaluationof evolvingtechnologiesastheyappliedtothe ProcessDevelopment
Department.
 Involvedinbasicandappliedresearchaimedatincreasingefficiencyof the cell culture process.
DevelopedandvalidatedDNA hybridizationassays
 Trainedand supervisedresearchtechnician
 Performedaminoacidcompositional analysisviaPITCderivatization,reverse phaseHPLC,SDS-
PAGE,Westerns,EIF,Size exclusionChromatography,andTrypticMappingforthe QC / Chemistry
department.Assistedinthe developmentof standardoperatingprocedures
 Outstanding Accomplishment:Performedaminoacidcompositional analysisviaPITC
derivatization,reverse phase HPLC,SDS-PAGE,Westerns,EIF,Size exclusion
Chromatography,andTrypticMappingfor the QC / Chemistrydepartment.Assistedinthe
developmentof standardoperatingprocedures
Grant / Contract Positions
WashingtonUniversitySchool of 1987 – 1987
Medicine St.Louis, Missouri
ResearchAssistant:Metabolism
Populationstudiesof Diabetesmellitusinthe Blackrace.Clinical diagnosticresearchtechniquesof the
glucose transportergene viaRestrictionFragmentLengthPolymorphism(RFLP's)analysis
 Utilizationof Southernblottransfermethod,0.8% agarose electrophoresis,32-Plabelednick
translation,andGuanidiumIsothiocyanateCsCl densitygradientisolationof mRNA andDNA.Other
dutieswere labrecordkeepingandRadiationSafetyOfficer
Monsanto St. Louis, Missouri 1987 -1987
Research Laboratory Technician:Pathology

10. 10
Molecularbiological techniquesastheyappliedtothe isolationandpurificationof oncogenicmRNA and
DNA to developassaysthatdetectactivationof oncogenesbyMonsantoproducts
 Developmentandstandardizationof protocolsforthe isolationandextractionof RNA andDNA
denaturinggels.Implementationof GuanidiumIsothiocyanateCsCl densitygradientcentrifugation
methodforRNA isolationandpurification
 Spectrophotometricdeterminationof nucleicacidconcentration.
 Necropsyandfreezingof ratpancreasand livertissue sample formRNA andDNA analysis
 MaintainingliquidnitrogenDewarof tissue samples
 Recordkeepingof Oncogene TissueBook
 Outstanding Accomplishment:Developmentandstandardizationof protocolsforthe
isolationandextractionof RNA andDNA denaturinggels.Implementationof Guanidium
Isothiocyanate CsCl densitygradientcentrifugationmethodforRNA isolationand
purification
Saint Louis UniversityMedical School 1986 - 1986
St.Louis,Missouri
Research Assistant:Microbiology
Microbiological techniquesinmammaliancellculture (MDBKandBARIV) includingsterile culture
techniques preparationof antibiotics,nutrients,andreagents
 Virologytechniquesincludinginfectingof cells,growingandisolationof the bovine influenzavirus,
hemagglutinationassays,hemacytometer,sucrose densitygradientcentrifugation
 Managed all laboratoryoperations,includingtrainingof graduate students,overseeingequipment
maintenance,orderingof supplies,andrecordkeeping
 Outstanding Accomplishment:Virologytechniquesincludinginfectingof cells,growingand
isolationof the bovine influenzavirus,hemagglutinationassays,hemacytometer,sucrose
densitygradientcentrifugation
Graduate - Level MolecularBiology Internship 1985 -1986.
WashingtonUniversitySt. Louis,Missouri
Dr. Roy Curtiss III
The onlyundergraduate studentamongSt.Louiscollegesanduniversitiesacceptedintothe graduate -
level internshipprogramformolecularbiologyandbacterial genetics.

11. 11
 Molecularbiological techniquesinrecombinantDNA technologywithE.coli andStreptococcus
mutans.Constructionof mapping,delivery,andshuttle vectorsforE.coli and S.
mutans.Transformationof bacterial cultures.
 Techniquesincludedagarose gel electrophoresis,mappingof endonucleaserestrictionsiteson
bacterial plasmids,ligation,and cloningof bacterial genesandplasmids,CsCl - EtBr density
gradientcentrifugation,mini- screens,toothpickreplicas.Media,reagent,andagarplate
preparation.
 Outstanding Accomplishment:Molecularbiological techniquesinrecombinantDNA
technology withE.coli andStreptococcusmutans.Constructionof mapping,delivery,and
shuttle vectorsforE. coli and S.mutans.Transformationof bacterial cultures.Techniques
includedagarose gel electrophoresis,mappingof endonuclease restrictionsitesonbacterial
plasmids,ligation,andcloningof bacterial genesandplasmids,CsCl - EtBrdensitygradient
centrifugation,mini - screens,toothpickreplicas.Media,reagent,andagarplate
preparation.
Education
Bachelor’s Degree inBiology
Saint Louis University,St.Louis, Missouri,1988
Publications
S. Nigam,A.Scotton,G. Ruezinsky,J.Dugger,S.Lombardo,P.Remsen,R.J.Cook,andR. Rupp;An
IntegratedApproachforValidatingCleaningProceduresinBiopharmaceutical ManufacturingFacilities;
RegeneronPharmaceuticals,Inc.,777 OldSaw Mill RiverRoad,Tarrytown,NY 10591; RecombinantDNA
BiotechnologyIII;October16-21,1995, Hotel duGolf,Deauville,France;presentedasposter.
Cook,R.J.,O. E. Khorkova;QuantitativeAnalysisof DNA inProteinProductsandFermentationMedia,
AutomatedMicrobial IdentificationandQuantitation;Technologiesforthe 2000s, InterpharmPress,
Inc.,1996.
Cook,R.J.,Price of Peace,HarvesterMagazine,1980.