Research Scientist

Experienced professional specialized in ELISA, HPLC chromatography, method validation for therapeutic proteins including binding antibody assays. Pharmacokinetic (PK), and GLP compliance seeking a Staff Scientist position within the pharmaceutical industry where I can utilize my diverse set of skills.

Excellent research and problem resolution skills

Able to work in a fast-paced production environment to meet established turnaround times

Perform work with a high degree of accuracy and attention to detail

Excellent communication skills (verbal and written)

Ability to work in a dynamic team environment

Ability to multitask

Highly organized

PROFESSIONAL EXPERIENCE

Laboratory Corporation Of America

Phoenix, AZ Dec 2016– May 2018

Laboratory Medical Scientist

Help setting up laboratory instrumentations and establishing laboratory protocols and procedures for clinical routine chemistry and /Immunochemistry assays, urinalysis, hematology, coagulation.

Maintains and calibrates equipment used to ensure it is operating efficiently and providing accurate results of clinical samples such as:

Roche Cobas 6000 C501/E601 Chemistry

Roche Integra 400/800 Chemistry

Sysmex XE-2100 Hematology

Siemens CA-1500 Coagulation

Siemens Atlas Urinalysis

Perform quality control tasks and maintain laboratory documentation according to SOP.

Eli Lilly and Company, Branchburg, NJ 08876 April 2010 – Dec 2014

Principal Research Associate, (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 were conducted in compliance with good Laboratory practice (GLP), 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.

Routinely track and document results in laboratory notebooks, databases and technical reports.

Analyze, summarize, and present experimental results to manager and other team members.

Huntingdon Life Sciences, East Millstone, New Jersey July 2005 – Dec 2009

Senior Scientist/ Study Manager (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 the aspects of Watson LIMS system, 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.

Banner Desert Medical Center, Mesa Arizona 2003- 2003

Laboratory Technical Coordinator

Coordinated workflow, quality check results, communicates with hospital staff to clarify any questions they have, and generally work to keep things humming along. Also, involved in policy creation and participate on various committees, ensuring employee input is represented accurately, Working on the bench as needed

Oversees the operation of the general laboratory department as well as reviewing released patient and quality control results.

Troubleshooting methods test and instrumentation.

Laboratory Corporation Of America Raritan, NJ 08869 1983- 2003

Medical Laboratory Team Leader

Overseeing the operation of Special Chemistry Section, 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.

EDUCATION

Bachelor of Science – Chemistry & Physics

Ain Shams University, Cairo-Egypt

Certifications

ASCP CERTIFIED, AMERICAN Society of Clinical Pathology-Chemistry

New York State Laboratory Medical Technologist License.

American Association for Clinical Chemistry (AACC).

Honored Member of Cambridge WHO’s WHO Achievement Recognition.

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