Renee Warrino, CQT

***** * ***** ******

Olathe, KS 66062

Phone 913-***-****

E-mail abk8ou@r.postjobfree.com

Objective To become a key member of a scientific team, utilizing the

knowledge and skill sets that I have gained from working in

several QC, R&D and Manufacturing departments. Also, I would

like to be a part of a fast paced, motivating environment that

can benefit from my enthusiastic attitude.

Work Scientist 2008-Present

Experienc Kansas City, MO

e Aptuit

Pharmaceutical service company that conducts research,

development and manufacturing on a contract basis

Worked as a Scientist in both the Commercial Quality Control

group, and currently in the Biopharmaceutical Characterization

group

Responsible for numerous human drug products release &

stability testing

Experienced in bioassay, cell culture, and gel electrophoresis

all performed in cGMP/GLP lab environment

Communicates with clients in concise manner and meets deadlines

on time, in full

Responsible for review of lab notebooks and quality reports for

thoroughness, accuracy and completion

Involved in instrument calibration and general laboratory

supply and maintenance

Habitually prepared for internal, client and regulatory agency

audits (compliance of current and new SOPs, updated training)

Compliance point person within the group, keeping focus on

quality issues and compliance for the bioassay team

Extensively trained in writing quality documents such as SOPs,

deviations, notice of events, corrective/preventative actions,

and lab investigation reports

Completed David Begg and Associates Program titled "Analysis

and Testing" Course trained on the importance of quality

systems, sampling and sample management, analytical methods,

validation, out of specification results, and laboratory

equipment maintenance/calibration

Interviewed new candidates and trained associates for lab

positions

Senior Product Specialist 2004-2008

Omaha, NE

Streck

Manufacturer of hematology, chemistry, and immunology controls

for the clinical laboratory

Responsible for the quality control of all the company's

immunology control products and numerous hematology control

products

Accountable for the development of assays associated with

assigned products.

Monitored and reported on the stability of assigned products to

specifications

Member of the QC Nonconformance/Corrective and Preventive

Action team

Continuously updated, revised, and wrote new protocols for

assay procedures

In charge of training documents for the entire QC department

and interacted with QA to keep the records up to date

Worked closely with Technical Services to resolve

customer-related issues.

Generated all of the Certificates of Analysis and Certificates

of Compliance for assigned products

Proficient in the following clinical flow cytometry techniques:

HIV-panel, ProCount, ISHAGE CD34, single/dual/four-color

staining, platelet staining (CD41/61)

Wide-spread knowledge in flow cytometry (Beckman-Coulter and BD

platforms)

Calibrated flow cytometry instrumentation and performed general

lab maintenance.

Vast experience in running the following hematology

instruments: Beckman-Coulter GEN*S, Beckman-Coulter LH750,

Beckman-Coulter STK-S, Bayer Advia 120, Bayer XT-2100, Bayer

XT-2000i, Cell-Dyn 4000, Cell-Dyn 3500, Cell-Dyn 3200, Cell-Dyn

1700, Cell-Dyn 1600

Research IV 2000-2004

Pittsburgh, PA

University of Pittsburgh

Department of Immunology

Active in a basic science immunology lab that focuses primarily

on receptors of immune cells (dendritic cells)

Extremely skilled in BSL 2 cell culture using a biosafety

cabinet and hemacytometer with trypan blue staining for

viability

Responsible for processing human and non-human primate blood,

resulting in macrophages and dendritic cells

Affluent in Flow Cytometry assays (Beckman-Coulter and BD

machines) for the following: phenotyping, apoptosis, bacterial

uptake, intracellular staining and tetramer staining

Numerous experiments performed using the following techniques:

cell culture (adherent and suspension cells), mixed leukocyte

reactions (MLR), ELISAs (especially IL12p40, IFN-? and IL2),

growing recombinant bacteria (E. coli) expressing various

protein constructs, SDS-PAGE gels, immunoprecipitation assays,

antibody purification, 3H cell proliferation assay and confocal

microscopy

Assisted in the training of rotating graduate students and SURP

(Summer Undergraduate Research Program) on various techniques

and experiments

Responsible for all of the ordering and record keeping

Radiation Safety Officer of the lab

Completed and certified in the following training programs:

Research Practice Fundamentals, Non-Human Primate Research,

Radiation Safety, Chemical Safety, Blood-borne Pathogens, and

Shipping of Hazardous Goods

Manufacturing Associate 1998-2000

Medford, MA

Eligix, Inc. (formally Coulter Cellular Therapies, Inc.)

(Miami, FL)

R/D, Manufacturer of transplantation and immune therapies for

cancers and infectious diseases

Performed purification of pharmaceutical grade antibody used in

Phase III clinical trials, using aseptic/cGMP technique

Wrote numerous SOPs concerning manufacturing and quality

control techniques

Purified monoclonal antibodies using Affinity Chromatography

(Protein A & G) and Anion Exchange Chromatography (Q Sepharose)

Manufactured pharmaceutical grade products, High Density

Microparticles (HDM), using aseptic/cGMP technique in both

Class 1000 and Class 100 clean rooms

Involved in the writing and completion of multiple batch

records for clinical manufactured products

Optimized product development of monoclonal antibodies labeled

with dense particles

Knowledgeable in the area of Quality Control, including method

and assay validation and qualification

Proficient in the following protein characterization methods:

SDS-PAGE Gels (reduced and nonreduced), Isoelectric Focusing

Gels, HPLC, Potency Assay, ELISA, BCA Assay, UV/VIS

Spectrophotometry

Experienced in buffer preparation using aseptic/cGMP technique

Education

& David Begg and Associates 2009

Training Kansas City, MO

Pharmaceutical QA/GMP consultants

Completed training course "Analysis and Testing"

University of Nebraska Medical Center 2005

Omaha, NE

Division of Medical Technology

Completed 3.0 CEU course in Clinical Hematology

American Society for Quality 2005

Omaha, NE

Certified Quality Technician (CQT)

University of Nebraska-Lincoln 1995-1997

Lincoln, NE

Degree: Bachelor of Science

Major: Chemistry Minors: Mathematics and Political

Science

Central Community College-Platte 1993-1995

Columbus, NE

Degree: Associate of Science

Major: Chemistry

Publicati Paul Q. Hu, Renee J. Tuma-Warrino, Marianne A. Bryan, Kathleen

ons & Mitchell, Darren E. Higgins, Simon C. Watkins, and Russell D.

Abstracts Salter, E. coli Expressing Recombinant Antigen and

Listeriolysin O Stimulate Class I-Restricted CD8+ T cells

following uptake by Human Antigen Presenting Cells, The

Journal of Immunology, 2004; 172: 1595-1601

Russell D. Salter, Renee J. Tuma-Warrino, Paul Q. Hu, and Simon

C. Watkins, Rapid and Extensive Membrane Reorganization by

Dendritic cells following Exposure to Bacteria Revealed by High

Resolution Imaging, Journal of Leukocyte Biology, 2004; 75:

240-243 (cover of journal features our images)

Ann M. Stewart-Akers, Russell D. Salter, Peter Keytel, Renee J.

Tuma-Warrino, Xin Dong and Penelope A. Morel, ?-glucan

Stimulated Dendritic Cells Enhance the Cytolytic Activity of

Natural Killer Cells, abstract at American Association of

Immunology 2003

Sandhya Kharbanda, Russell D. Salter, Xin Dong, Renee J.

Tuma-Warrino and Richard A. Steinman, BDCM: a novel B-cell line

with Genetic and Functional Similarity to Dendritic cells,

British Journal of Haematology, 2002; 119, 819-825

Honors & American Society for Quality, 2005

Membershi Keynote Speaker at Women In Science Conference, 2003

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Reference Available upon request

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