Clinical Laboratory Scientist

SHARIF SYED

**** ********* ***, *** ****, CA ****4

734-***-**** ********@*****.***

BRAND STATEMENT

A positive, enthusiastic and versatile scientist with 5+ years of

experience at Abbott Laboratories. Passionate about troubleshooting issues

that lead to increased reliability of diagnostics products, thus positively

affecting customer satisfaction and cost to the organization. Experience

working in various areas of clinical laboratory including immunology,

hematology as student intern.

EXPERTISE/SKILLS

. Trained in using the following Abbott Instruments: ARCHITECT

immunoassay System (i1000SR and i2000SR instruments), ARCHITECT

clinical chemistry System (C8000 and C4000 instruments)

. Proficient in CLI scripting; authored robotic automation procedures

. Familiar with conducting statistical data analysis via JMP programming

. Working knowledge of extracting data from Abbott Link and using LOG-IC

to analyze large scale data

. 5+ years of experience working in an FDA and ISO regulated environment

WORK EXPERIENCE

ABBOTT LABORATORIES

Systems Integration Specialist

Abbott Park, IL

System and Assay Integration

Mar 2013 - June 2014

. Conducted life testing on prototype parts (check valves and pumps) to

support cross contamination robustness studies in efforts to ensure

efficiency in testing and maintain focus on customer satisfaction

. Completed development studies to verify probe positioning

functionality (robocal) of various pipettes from different vendors,

evaluating robustness of the pipetting process

Data Management

. Analyzed large sets of data both from in-house testing and from the

customer sites for analytical sensitivity, specificity, precision and

carryover testing.

Scripting

. Conducted studies and investigated possible electronics or mechanical

changes to the analyzer while troubleshooting customer issues

. Authored robotic automation procedures for Infectious diseases assays

to reduce carryover, and other for Abbott Molecular to resuspend the

micro-particles, aided in the evaluation of parameters that allowed

complete re-suspension

Customer Complaints/Troubleshooting

. Worked with cross functional teams to investigate root cause for

performance issues and understand data discrepancies with assay

performance and other customer complaints for multiple assays;

contributed positively in improving customer satisfaction and lowering

cost to the organization

R&D Scientist (Assay Development)

Abbott Park, IL

May 2010 -

Mar 2013

. Conceptualized, designed, conducted and documented various R&D

feasibility studies including design verification, validation, and

reagent cross contamination

. Executed the design verification protocols and documented results in

Electronic Laboratory Notebook; prepared design review deliverables

for status updates to management

. Characterized reagent and sample cross contamination testing protocols

to ensure compatibility of in-development diagnostic assays with

current ARCHITECT instrument (i1000SR, i2000, i2000SR) on-market

assays

. Analyzed, summarized, and presented data collected from various R&D

studies both within the team and across cross-functional departments;

this data has been assimilated into the design records for subsequent

FDA submissions

. Performed necessary daily, weekly and monthly GMP and instrument

maintenance procedures

. Trained the junior incoming contractors on ARCHITECT instruments

Clinical Research Assistant

Abbott Park, IL

May 2009 - Apr 2010

. Monitored several clinical sites in US for accuracy and data/document

integrity throughout the course of a study by doing pre-qual,

initiation, interim and close out visits, ensured smooth execution of

design validation studies

. Designed and reviewed case report forms and study packets for the

clinical sites; authored basic protocols and clinical brochures in

compliance with the Good Clinical Practice(GCP) guidelines

. Ensured that clinical investigative sites are protecting the subject's

rights and safety, adhering to clinical protocols, Standard Operating

Procedures, ICH guidelines, Good Clinical Practices and FDA

regulations and also the HIPPA Guidelines

. Reviewed the investigational sites regulatory documents according to

ICH/GCP guidelines and 21 CFR, IUO product accountability Forms, and

prepared site visit reports

. Audited multiple in-house specimen collection studies for accuracy and

patient integrity to ensure compliance with Abbott Laboratories

Standard Operating Procedures

Quality Assurance Data Verifier

Abbott Park, IL

Dec 2008 - Apr 2009

. Reviewed and compared data line listings with source documents from

multiple Clinical Investigative sites to ensure compliance before FDA

submission

. Verified the clinical data according to the approved QA Verification

Plan, resolved discrepancies, ensured complete and accurate data

reporting

LAB SCIENCE EXPERIENCE

GENESIS LABS

Chicago, IL

Student Intern

Feb 2008 - Aug 2008

. Body Fluids: Experience evaluating several body fluids both

macroscopically and by performing cell counts and differentials on these

fluids

. Hematology:

. Performed CBCs, differentials, special staining procedures and various

hemostasis tests

. Trained on the following analyzers - COAG (Dade Behring/Siemens BCS),

HEME (XE-2100-Sysmex America), URINE (Clinitek Atlas - Bayer

Diagnostics/Siemens Diagnostics)

. Immunohematology: Proficient in conducting blood typing, screening,

antibody identification, cord blood testing, crossmatching etc

. Urinalysis:

. Knowledge of macroscopic, chemical and microscopic analysis, different

confirmatory tests, trouble-shooting instruments and quality control

of various tests

. Trained on the following analyzers - Clinitek Atlas - Bayer

Diagnostics/Siemens Diagnostics, URINE (Clinitek Atlas - Bayer

Diagnostics/Siemens Diagnostics)

. Chemistry: Trained on different chemistry analyzers

. Utilized HPLC (BIO-RAD Biologics duo flow & SHIMADZU) for product

purification

ROSALIND FRANKLIN UNIVERSITY LABORATORY

North Chicago, IL

Student Intern

Nov 2007-Dec 2007

. Molecular: Familiar with use of instruments such as flowcytometry,

automatic cellular imaging equipment, PCR assays (DQ alpha, HPA -1, PAI

-1 and factor XIII) and several other tests done on-site.

HINSDALE HOSPITAL

Chicago, IL

Student Intern

July 2007 - Oct 2007

. Microbiology:

. Performed various microbiology, parasitology, and mycology tests and

procedures

. Working knowledge of equipment such as bacte-alert for blood cultures

and viteck - 2 for identification and testing sensitivities of many

organisms

. Immunology: Performed Latex tests, Rapid tests, Agglutinin tests,

Enzyme and Radio immunoassay procedures

. Management: Shadowed the lab manager in scheduling of employees,

budget reviews, mock CAP inspection, candidate interviews, performance

reviews and also attended the regional lab directors meeting for the

Adventist health system

. Experience using Laboratory Information System (LIS)

EDUCATION

ROSALIND FRANKLIN UNIVERSITY OF MEDICINE AND SCIENCE

North Chicago, IL

Masters in Clinical Lab Science

Graduated Dec 2008

OAKLAND UNIVERSITY

Rochester,

MI

Bachelors in Health Science

Graduated May 2005

CERTIFICATIONS

. Certified Medical Laboratory Scientist, MLS (ASCP)CM (2009 -

Present)

. California Licensed Clinical Laboratory Scientist

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