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Title Clinical Laboratory Project Manager
Target Location US-NJ-Singac
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Candidate's Name
Street Address  PHONE NUMBER AVAILABLE EMAIL AVAILABLEHigh-performing manager/technologist with a NYS license (Clinical Laboratory Technologist) having over 20 years of experience in a fast-paced laboratory and medical office environment.EducationMichigan State University, East Lansing, MICertification, Immunodiagnostics and Clinical Flow Cytometry, 2007-2008Fairleigh Dickinson University  Metropolitan Campus, Teaneck, NJBachelor of Sciences, Biochemistry, 1997-2002Center of Disease ControlCreating Next-Level Training for Clinical and Public Health Laboratory Professionals (currently enrolled in)Experience[October 2022- present]Project Manager Gedroic Medical InstituteProcess designated in house labs.Organizing lab processes for all the out-of-practice labsEnsuring kits for testing are prepared in advance for patients and available to the front office.Communicate with the CEO and Office Director if any issues arise.Assist the CEO, as needed, with research, article procurement, and reviews.Be a source of practice regarding any lab testing questions that may arise.Ensure laboratory results are resulted and are available in the patients chart.Act as a technical resource for laboratory testing and resultsManage Dr. Gedroics scientist conference.Manage, track, and oversees IRB study.Manage and track proprietary kit development with third parties.[January 2022- October 2022]Laboratory Manager Gedroic Medical InstituteManage day to day operations of the laboratory.Conducting and overseeing quality assurance and quality controlCoordinate workflowParticipates in the development of procedures and company policies.Monitors work activities to ensure compliance with established policies, procedures, and regulatory standards.Recommend and assist in the implementation of goals and objectives.Implement and maintain the quality assurance program.Prepare monthly, quarterly, and annual compliance reports.Coordinate and monitor contract services, purchasing of equipment, and reagents (procurement), and billing.Submit budget recommendations and monitor expenditures.Reviews validations[June 2020- December 2021]Laboratory Supervisor Gedroic Medical InstituteOrganize and direct the daily operational activities of the laboratory.Is an active participant on the Laboratory and Institute Management teams.Provides oversight for assay method development, accreditation, and another operational laboratory and/or Institute initiatives.Implement and enforce quality standards as per Institute and regulatory agencies requirements.Prioritizes daily operational activities.Performs laboratory testing as needed.Interviews potential employees, recommends new hires, disciplines employees, and recommends firing employees as appropriate.Prepares and administers performance appraisals.Oversees work schedules to assure adequate staffing.Reviews proficiency testing results with laboratory directorSubmits proficiency testing results online.Performs root cause analysis if proficiency testing failed.Provide turn-around-time (TAT) management.Acts as a technical resource for instrumentationEvaluates new procedures and instrumentation for implementation.Oversees technical performance.Responsible for planning, directing, and overseeing the fiscal health of the laboratory.Review testing analysis completed by technologists and/or technicians.Train new technologists and techniciansEnsures that all SOPs are in compliance with all regulatory agencies.Updates and monitors laboratory compliance and quality monitors with regulatory agencies and the Institute standardsCommunicate with team members within and outside the laboratory across the Institute.Assist in any additional administrative duties of laboratory operations and/or the Institute.Use SharePoint to store electronic versions of SOPs.[July 2018- April 2020]Flow Cytometry Supervisor CBL PathResponsible for planning, directing, and overseeing the operations and fiscal health of the Flow Cytometry DepartmentReview testing analysis completed by technologist.Implement and enforce quality standards as per CBL Path and regulatory agencies requirements.Prioritizes daily operational activities.Performs laboratory testing as needed.Evaluates new procedures and instrumentation for implementation.Oversees technical performance.Ensures that all SOPs are in compliance with CAP, CLIA, NY State, and the Joint Commission regulations.Reviews proficiency testing results with laboratory directorSubmits proficiency testing results online.Performs root cause analysis if proficiency testing failed.Train new technologists and techniciansAssist in administrative duties of laboratory operations.[February 2017- July 2018]Flow Cytometry Technologist CBL PathAccessing samples in the laboratory to be processed.Made cocktails to be used for the different panels.Processed blood, bone marrow, and tissue specimens for cancer diagnosisAnalysis of samples that were processed using FCS ExpressDaily and monthly Quality Control on Beckman Coulter Navios machinesTrain inexperienced staff on quality control procedures and SOP's based on NY State, CLIA, and CAP standards[January 2017- February 2019]Flow Cytometry Supervisor Mountain Lakes PathologyResponsible for planning, directing, and overseeing the operations and fiscal health of the Flow Cytometry DepartmentReview testing analysis completed by technologist.Train new technologists and techniciansSupervisor all flow cytometry staffReview testing analysis completed by technologist.Implement and enforce quality standards as per CBL Path and regulatory agencies requirements.Prioritizes daily operational activities.Performs laboratory testing as needed.Evaluates new procedures and instrumentation for implementation.Oversees technical performance.Ensures that all SOPs are in compliance with CAP regulations.Reviews proficiency testing results with laboratory directorSubmits proficiency testing results online.Performs root cause analysis if proficiency testing failed.Assist in administrative duties of laboratory operations.[May 2014- January 2017]Flow Cytometry Technologist Mountain Lakes PathologyProcessing blood, bone marrow, and tissue specimens for cancer diagnosis and communicate results to Hemapathologist.Produced high-quality results for referring physicians.Maintain and calibrate BD FACS CaliburRecord keeping[October 2013- February 2017]Study Manager/Senior Analyst Envigo (Formerly Huntingdon Life Sciences)Study Manager for specific customer accountsDraft study reports and validation plansDevelop study documents and tools, as needed (e.g., worksheets, various site, and client communication documents)Interfaces with Scientific Operations, Management, Quality Assurance, and Study Directors dailyAuthorship of SOPs and methodsPeer review of data and draft study reportsTemplate generation for FCS ExpressConduct method development, validation, and sample analysis as per study method, SOP, protocol, and/or analytical/validation plans in accordance with GLP/GCP for Flow Cytometry and ELISA.Train junior staff members and new hires according to SOPs and departmental policies.Perform FACS analysis with FCS Express with data generated from FACS Canto and/or FC500; perform analysis on Agilent 2100 Bioanalyzer and Thermo Scientific Nano Drop 2000/2000c.Worked as a team member to ensure proper test procedures and results.[November 2011-October 2013]Primary Technologist Bio-Reference LaboratoriesPerformed lab tests and communicated high-quality results for referring physicians.Managed caseload of thousands of test results produced each day.Participated in unit-based Quality Assurance Program and evaluated Quality Controls and calibration using Real Time Solution and Unity Programs.Train inexperienced staff in quality control procedures and SOP's based on NY State, CLIA, and CAP standards. Worked as a team member to ensure proper test procedures and results.Worked with Roche E170, Siemens IMMULITE 2000, and Siemens Centaurs XP.[April 2005-September 2011]Assistant Supervisor/Lead Flow Technologist Bio-Reference LaboratoriesAccessing samples in the laboratory to be processed.Made cocktails to be used for the different panels.Processed blood, bone marrow, and tissue specimens for cancer diagnosisAnalysis of samples that were processed using CellQuest Pro, FACSDivia, FACSCanto Clinical Software, and FCSExpressDaily and monthly Quality Control on FACSCalibur and Canto II machinesKeeping track of additional testing requested by doctors, number of samples processed in the lab.Train inexperienced staff in quality control procedures and SOP's based on NY State, CLIA, and CAP standards Taking care of inventory.[July 2003- March 2005]QC Lead Tech Progenitor Cell TherapyQC Supervisor for specific customer accounts.Record keeping.Reviewing data generated from QC assays.Coordinate material transfers, blood products that were processed inside the cleanroom, with outside health care facilities including Mt. Sinai, Hackensack University Medical Center, and UMDNJ. Inspection and verification of patient medical charts for facilitation of stem cell transplants.Perform QC testing which includes endotoxin detection using the kinetic and gel-clot methods, complete blood counts, viability, FACSCalibur involving staining, acquisition, and analysis of patient samples, gram stain, ELISA, and sterility.Authorship and review of Standard Operating Procedures/Policies regarding OSHA standards. Manage laboratory supplies.Cleanroom monitoring using RCS, Met One, contact plates.Cleanroom gowning into a class 100,000 and class 10,000 rooms with laminar flow and working under a Biological Safety Cabinet[May 2002- July 2003]Organic Chemist Aqua Pro TechPerforming organic and inorganic testing for environmental agents (i.e., volatile organic compounds, pesticides, herbicides, hydrocarbons, well water testing)AbstractsVariability of cytokine response following ex vivo stimulation of blood from Cynomolgus monkey S Chilakala, M Castellana, J Doughty, K Patel, D Trani, R Chen, J Hanke, M Perpetua, G Bannis, Yi Qun Xiao; SOT; Mar15Reducing immunogenicity in a T cell dependent antibody response (TDAR) in cynomolgus monkeys leads to a sensitive assessment of immunosuppression by abatacept (CTL4A-IG)  G Bannis, MS Perpetua, D Trani, T Ziegelhofer, J Doughty, A Curran, LA Coney; ACT; Nov14.Quantitation of CD4 and CD8 regulatory T cells in the Cynomolgus monkey using CD127 and CD25 expression- A Beavis, S Harvey, D Trani, M Perpetua, G Bannish; May14Reducing immunogenicity in a T cell dependent antibody response (TDAR) in cynomolgus monkeys leads to a sensitive assessment of immunosuppression by abatacept (CTL4A-IG)  G Bannis, MS Perpetua, AJ Beavis, B Fraszczyk, S Harvey, D Trani, T Ziegelhofer, J Doughty, A Curran, LA Coney

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