A challenging opportunity in Assay Technology Assessment and Evaluation.
Time Management and Organizational Skills.
Quickly adapt to changes to realign
Problem solving and analytical skills.
Interpersonal and Leadership
Project Planning and Scheduling
Clinical Trial Management
Experimental Design, Data analysis, and Interpretation
Understand FDA submission process (510K and CBE-30)
Process Excellence Six Sigma Green Belt Certified (SIPOC, FMEA, Gage R&R, DOE; etc.)
Immunodiagnostic Assays development (Infectious Disease, Cardiac, Sepsis; etc)
Strong background with VITROS analyzers and assays.
Education and Training
Bachelor of Science:Medical Technology2001State University of Buffalo, Buffalo, NY
Clinical Laboratory Technologist New York State Licensure (License No: 012588)2007
ASCP certified Medical Technologist2002
Process Excellence Green Belt Certification2005
Good Clinical Practice Training2007
Ortho Clinical DiagnosticsRochester, NYSenior Scientist03/2016 to Current
Led and maintained multiple
assay projects simultaneously for the Assay Architecture Team.
Planned assay evaluations
aligning to project timelines to meet strategic imperatives.
Led assay assessment, analysis drawing, and conclusions to move forward
the assay design.
Performed research to assist with assay development to enhance or
troubleshoot assay performance.
Mentored other scientists to further their developmental growth.
Wrote Technical Documents.
Presented to cross functional teams.
Presented project outcome to customer forum, such as AACC.
Ortho Clinical DiagnosticsRochester, NYScientist II02/2005 to 02/2016
As a Scientist II I have been requested to assist within many projects within multiple platforms from Assay Architecture (Phase 0 to Phase 1 assay assessment), Point of Care assay and system development teams, Assay and System development for Donor Screening, Immunodiagnostic Assays and Dry Slide Technology platforms, and Site Management for Internal and External Validation Trials for the VITROS 5600/3600 Platforms.
Within these various roles my responsibilities included the following:.
Initiate experimental design and assisted with project planning to meet project goals.
Execution of experimental design and Interpretation of data.
Interfaced with cross-functional teams.
Authored FDA submission documentation, Strategy documents, FMEA assessments, verification/validation/technical reports, and experiment summaries.
Presented technical data to internal (i.e.
Team meetings, Assay Review board) and external venues (i.e.
Led various Assays and System assessments.
Led laboratory test schedule and tasks.
Site Manager for external trials.
Prepared contracts, financial disclosures, and test protocols.
Managed IRB submissions and sample collection.
Conducted protocol training, site start-up/close-out visitation, and continued site supervision.
Liaison between OCD lawyers and customer site to complete Trial Contracts.
Established a refurbishment program for the 5,1FS (at the time there was no process in place).
Ortho Clinical DiagnosticsRochester, NYScientist I08/2003 to 03/2005
Development of Infectious Disease/Transfusion Medicine/Immunodiagnostics Assays
Maintained lab quality control
Executed and documented experimental test designs for donor screening and diagnostic assays, feasibility of a new donor screening system
Ortho Clinical DiagnosticsRochester, NYTechnical Support Specialist I07/2001 to 08/2003
Provided customer assistance for the Clinical Chemistry and Immunodiagnostic Division
Provided troubleshooting assistance and resolution for customer equipment and assay complaints/concerns for all Chemistry/Immunodiagnostic analyzers (DT60, 250, 550, 750, 950, and ECI)
Assessed chemistry issues for potential Health and Safety, and reported events to Quality Assurance/Customer Quality personnel following FDA required protocol
Documented customer interaction and resolution within call management system
Proficient with Microsoft Office Word, Excel (Analyze-It), Outlook, and Power Point applications.
Familiar with Microsoft Access and Project
Proficient with the following data analysis tools: StatisPro (CLIA), Minitab, MicroSoft Excel Analyse-IT, OARS
Certified Process Excellence Six Sigma Toolls SIPOC, FMEA, Gage R&R, DOE design and analysis, in addition to other specific OCD analysis tools
Bachelor of Science : Medical Technology 2001 Clinical Laboratory Technologist New York State Licensure (License No: 012588) 2007 ASCP certified Medical Technologist 2002 Process Excellence Green Belt Certification 2005 Good Clinical Practice Training 2007
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