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Principal Research Associate Resume Example

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PRINCIPAL RESEARCH ASSOCIATE
Professional Overview
A professional scientist with a demonstrated ability to deliver quality results on very aggressive timelines. Responsible and willing to work hard to meet corporate goals by maintaining project schedules, ensuring individuals are trained and informed of expectations, ensuring GLP and GCP compliance, monitoring sample shipment and receipt, data acquisition, data analysis, and data reporting. Experienced in pharmacokinetic (PK), anti-drug antibody (ADA), neutralizing anti-drug antibody (NAb), and numerous analytical chemistry techniques
Education
Bachelor of Science : Chemistry & PhysicsAin Shams University － Cairo, EGBachelor of Science - Chemistry & Physics Ain Shams University, Cairo-Egypt Certifications ASCP CERTIFIED, AMERICAN Society of Clinical Pathology-Chemistry
License : Clinical ChemistryNew York State Clinical Laboratory Supervisor License American Association for Clinical Chemistry (AACC) HONORED MEMBER OF CAMBRIDGE WHO'S WHO ACHIEVEMENT RECOGNITION.
Experience
Principal Research Associate
April 2010 to December 2014Eli Lilly and Company － Branchburg, NJ(5 Years) ◆ Manages number of projects and validation of methods, developer of Immunoassays (ELISA) to study the binding specific interactions of analytical and Bioanalytical methods. ◆ Design the development and validation of immunoassays and molecular assays ensuring that all critical stages of studies are conducted in compliance with good clinical practices (GCPs), internal or external collaborators SOPs and all applicable regulatory requirements as appropriate including assay troubleshooting. ◆ Developing and validating immunogenicity testing using MSD method validation for therapeutic proteins including binding antibody assays. ◆ Successfully planned and Utilize Colorimetric ELISA methodology for dual quantitation of both Total antibody and Antibody drug conjugate (ADC) for the same ADC molecule.
Senior Scientist/ Study Manager
July 2005 to December 2009Huntingdon Life Sciences － East Millstone, New Jersey(5 Years) ◆ Performed ELISA Method validation and sample analysis assays for drugs and antibodies to drugs for the clinical and pre-clinical studies for variety of sponsors. ◆ Assist Project Manager in tracking work-in-progress and directing other project team members. Effectively communicates with team members and supervisors regarding work-related issues. ◆ Actively participated and performed as a team leader in training sessions related to job functions. ◆ Familiar with all aspects of Watson LIMS, use of the relevant modules and functions. Utilizes Watson for assay run set up, analysis, quantitation, reviews, project status. ◆ Reviewed analytical data for acceptability of calibration, control values, response curve characteristics and quantitative limits. ◆ All Laboratory functions were conducted in compliance with good clinical practices or external collaborators SOPs and all applicable regulatory requirements.
Laboratory Technical Coordinator
January 2003 to January 2003Banner Desert Medical Center － Mesa, Arizona◆ Overseas the operation of the general laboratory department as well reviewed released patient and quality control results. ◆ Troubleshooting of test methods and instrumentation.
Medical Laboratory Team Leader
January 1983 to January 2003Laboratory Corporation Of America Raritan － Raritan, NJ◆ Overseeing the operation of Special Chemistry Department and oversight and evaluation of technical staff; reviewed released patient and quality control results ◆ Performed manual and complex assays at a highly skilled level using laboratory instruments including Primus, Bio-RAD (Variant HPLC), HELENA SPIFE 3000, atomic absorption (Graphite Furnace 4100Z), Spectrophotometer, Cooximeter (ASV), Immunoassay and electrophoresis. ◆ Served as an organizational liaison for quality assurance and laboratory compliance with established protocols. Resolved complex problems and quality issues. ◆ Provided technical guidance in the troubleshooting of test methods and instrumentation. ◆ Administered proficiency testing to all required staff and monitor timely completion of CAP, New York State, PA Surveys and other regulatory agencies.
Memberships/Scholarly Societies
ASCP CERTIFIED, AMERICAN Society of Clinical Pathology-Chemistry
Certifications
ASCP CERTIFIED, AMERICAN Society of Clinical Pathology-Chemistry
Skills
Laboratory, Testing, Instrumentation, Quality Control, Chemistry, Absorption, Atomic Absorption, Electrophoresis, Hplc, Immunoassay, Liaison, Medical Laboratory, Quality Assurance, Rad, Spectrophotometer, Elisa, Method Validation, Sops, Adc, Antibody, Associate, Bioanalytical, Immunoassays, Therapeutic, Antibodies, Calibration, Clinical Studies, Lims, Pre-clinical, Progress, Project Manager, Quantitative, Training, Watson Lims, Ada, Analytical Chemistry, Data Acquisition, Data Analysis, Data Reporting, Gcp, Glp, Marketing Analysis, Pharmacokinetic, Ascp, Ascp Certified, Clinical Laboratory
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Resume Overview

Companies Worked For:

  • Eli Lilly and Company
  • Huntingdon Life Sciences
  • Banner Desert Medical Center
  • Laboratory Corporation Of America Raritan

School Attended

  • Ain Shams University

Job Titles Held:

  • Principal Research Associate
  • Senior Scientist/ Study Manager
  • Laboratory Technical Coordinator
  • Medical Laboratory Team Leader

Degrees

  • Bachelor of Science : Chemistry & Physics
    License : Clinical Chemistry

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