senior scientist resume example with 19+ years of experience
JessicaClaire
Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK Home: (555) 432-1000 - Cell: - resumesample@example.com - : - -
Objective
A challenging opportunity in Assay Technology Assessment and Evaluation.
Skills
Time Management and Organizational Skills.
Quickly adapt to changes to realign
Problem solving and analytical skills.
Interpersonal and Leadership
Project Planning and Scheduling
Customer Service
Quality Control/Assurance
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
Expected in 2001 to to
Bachelor of Science: Medical Technology State University of Buffalo - Buffalo, NY GPA: Status -
Expected in 2007 to to
: Clinical Laboratory Technologist New York State Licensure (License No: 012588) - , GPA: Status -
Expected in 2002 to to
: ASCP certified Medical Technologist - , GPA: Status -
Expected in 2005 to to
: Process Excellence Green Belt Certification - , GPA: Status -
Expected in 2007 to to
: Good Clinical Practice Training - , GPA: Status -
Experience
02/2016 to Current
Senior ScientistCatalent Pharma Solutions, Inc. – San Diego, CA,
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.
02/2005 to 02/2016
Scientist IIAmerican Chemical Society – Columbia, MD,
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.
AACC).
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).
07/2003 to 02/2005
Scientist IWuxi Apptec – Natick, MA,
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
06/2001 to 07/2003
Technical Support Specialist IPeoples Bancorp Inc. – Hillsboro, OH,
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
Computer Skills
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
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