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Click here or scroll down to respond to this candidateCandidate's Name
Street Address Gypsy Moth DriveColumbia Missouri Street Address
PHONE NUMBER AVAILABLE EMAIL AVAILABLEExperienced Pharmaceutical Lab Manager;adept in Quality,FDA Regulations, and Project ManagementTwenty years of diverse industry and clinical environment experienceExemplary management and leadership intelligenceExcellent attention to detail in maintaining quality and complianceProficient in QA, QC, PV, GXPs, and QMSProficient in FDA/USDA/HACCP/ISO/ICH/CMC/MDRCreative and innovative problem solverProblem solver, goal achiever, and people motivatorCORE COMPETENCIESLab Techniques HPLC GC UPLCTGA/DSC GC/MS XRD XRF FTIR SEM ATM UV/VIS Optical Microscope (Leica) Acoustic Particle SizeSoftware: Oracle OpenLab Empower ERP (SAP) SaaS such as (MS office, Word, Excel, Power Point, Outlook) Teams Lab Solutions LIMS Cerner (Power Chart) Citrix (Workspace) EMR (REDCap)Regulatory experience: IRB IND IDE IDS CDA CTA ICFClinical Training/Classes: Clinical Trial Investigator Clinical Research Study CoordinatorRelated ExperienceUniversity of Missouri, Columbia Mo 2023Regulatory Affairs CoordinatorAssisting School of Medicine (SOM) departments in the initiating and opening of externally sponsored clinical research projects and trialsProactive in creating/maintaining Regulatory Study binders to house all electronic study related documentationAct as the IRB/Regulatory Start-Up specialist and clinical research liaison for MU SOMAssisted with Investigational Drug Services (IDS) enrollment processesReviewing requests and granting medical record access to external monitors per institutional processes, rules, and guidelinesServe as the primary clinicaltrials.gov administrator for University of Missouri SOMSupported the MU SOM clinical research staff by creating and maintaining the educational, onboarding, and offboarding documentationContributed administrative support for clinical research FDA investigational new drug (IND) applications and clinical research FDA investigational device exemptions (IDE).Collaborated with CROs/Sponsors/Principal Investigators to determine feasibility of clinical trial studiesProactive in the creation and modification of Informed Consent (ICF) documentationAssisted in the submittal of Confidential Disclosure Agreements (CDA) and Clinical Trial Agreements (CTA)Monitor EMR Account Access and assist Study Monitors with REDCap form completionSupport upcoming Monitor Visits by assisting in the completion of Remote Records Request/Monitor Visit required documentationAltaSciences, Columbia MO 2021-2023Pharmaceutical Laboratory ManagerPrimary resource/SME for all DFA related actions including the construction, design, and commencement of the first on-site Dose Formulation Analysis (DFA) Laboratory for AltaSciences in Columbia MissouriMange the overall operation of the DFA laboratoryCongruently work with additional AltaScience DFA sites to ensure aligned needs and expectations for DFAEffectively communicate elaborate scientific information with Sponsors, Clients, and StakeholdersLeveraging strategic relationships with department heads/managers for ongoing, successful collaborationExceptional logical skills with excellence in written and verbal communication skillsUtilize CAPA/RCA to continually improve processes, identify potential issues and track through completionPerform PV of drug formulations by detecting, assessing, understanding adverse effectsComply with GXPs and ICH E6 Good Clinical Practices (GCP)Perform qualifications and validations on laboratory instruments such as HPLC and UPLCUtilize QMS to minimize lab risks, maximize project/sponsor/customer opportunities and satisfactionDeveloped KPIs to instantly assess lab successes and areas of improvementImplemented a QbD to ensure continued quality and regulatory standards are constantly being metDevelop, revise, review, and implement Standard Operating Procedures (SOPs)Resolves critical/major issues that are not defined by SOP and that may have impact to regulatory systemsAssist in the preparation, review, and submission of IND and NDA to the FDAShow excellent comprehension and application of FDA regulatory requirementsDirectly manage a team of scientists and chemists working in the DFA labManaged performance of lab personnel and ensuring all personnel adheres to QA and FDA regulationsConduct performance reviews and encourage lab personnel to strive for continuous improvementSet annual budget/spending and managed expenses within the departmentCollaborate with QA department to ensure DFA lab compliance and address concerns if necessaryCreate DFA standard work, training manuals, controlled/non controlled formsEnsure the safety and security of all study related data via practicing data integrityPerform R&D and Method Development for DFA testing including validation and qualification testingPerform Homogeneity testing, concentration testing, and stability testingCross trained in the Formulations department to encourage collaboration with DFA and TMD departmentsTake part in practice audits to prepare for future regulatory audits (FDA, USDA)Serve as lead for 3rd party testing audits and inspectionsExcellent organizational and time management skills to complete all projects on timeFoster a business environment that encourages continuous learning and progressionImplement a Laboratory Quality plan and ensure that DFA staff adhere to the quality planConnect with V.P of Operations to communicate needs of lab with staffing, training, etcAct as project manager for laboratory and take on independent projectsEnsure lab is safe and all lab personnel is performing lab tasks in safe mannerSynexis, Lenexa, KS 2019-2021R&D ChemistAssisted Advanced Technologies Group (ATG) in R&D Lab to improve the future and current operation and production of Synexis medical device productsAssist in 510(K) submissions for Synexis medical devicesLead the CMC team with training and guidanceAssist in the manufacturing operations of Synexis medical devices utilizing GMPsIdentify places of improvement for catalyst, sail, and sail/product packagingLead, design, characterize, and develop materials of interest for research and developmentCompile and analyze analytical data into reports and present findings to R&D personnelAnalyze daily catalyst production samples for product qualificationUnderstand how Synexis products perform and the vision or goals of SynexisLeveraged a broad understanding of material chemistry in order to advance the R&D departmentCollaborated/communicated with additional departments and team members as neededSuccessfully worked on independent projects with little to no supervision and group-led projectsLead R&D team to identify problems and draft medical device adjustmentsManaged multiple projects and assignments concurrentlyMaintain ongoing training with new instrumentationServe as SME (subject matter expert) for UV/VISWork with 3rd party companies for outside product testingProficient in lab notebook writing and lab practices/ lab safetyStrong customer service focus by communicating with customers with limited chemistry knowledgeAttend weekly Photocatalysis meetingsInstruments utilized: GC, TGA, GC/MS, XRD, XRF, FTIR, SEM, ATM, UV/VIS Optical Microscope (Leica)Rheology instrumentation utilized: Zeta Sizer and viscometerADM, Overland Park, KS 2017-2019Analyst IIITested various finished food products using HPLCPrepare, analyze, calculate, enter data into LIMs databaseCalibrated scales, ovens, and pipetsTrained chemists on new instrumentation and SOPsTroubleshoot instrument/data issuesWorked as a team to meet deadlinesReviewed existing SOPs for improvementsContact hazardous waste removal when necessaryAttended monthly lab safety meetingsKeep lab clean and safe of hazardsPerformed testing for:Vitamins (Niacin, folic, Thiamine, Folate, A),Fiber content, Fat content, Moisture content, Protein contentGreat Plains Analytical Lab Kansas City, MO 2012-2017R&D HPLC ChemistChemical Analysis of various finished products following SOPsFollow ISO 9001 quality management standards.Analysis of 3rd party CPG products on HPLC, GC, and additional scientific instrumentationPerform data analysis, interpreted results, entered data into LIMsPerformed monthly instrument/tools calibrationPerformed weekly lab orderingDeveloped method for sugars (with assistance) and assisted with additional method developmentTrain and support new chemistsCollaborate daily with lab colleagues to delegate tasksLead role in training new supervisorCommunicated and supported lab staff and lab manager to complete special projectsTroubleshoot and perform maintenance on instrumentsTroubleshoot current methods for optimizationContact hazardous waste removal when neededServed as safety scout to laboratoryCultivate a safe, clean work environmentInstrumentation used: HPLC (detectors utilized: UV, RI, and Fluorescence), GC.Product Testing vitamins niacin, folic, C, B, D, A content methionine content amino acid contentcholesterol content fat content mycotoxin content sugar content phytic acid contentEducationBachelors of Science, Biotechnology, University of Nebraska at Omaha 2009Minor: ChemistryManufacturing Associate/Quality Chemist (Internship)ConAgra Foods, Omaha NE 2005-2009Worked with food chemists to analyze fibers, sugars, flours, amino acids, toxin contents.Assisted in the manufacturing warehouse, production warehouse, and continuous improvement areasUtilized FDA regulated GMPs (21 CFR part 110) during the manufacturing process to ensure effective food safety and quality |
