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Project Manager Quality Control

Location:
Lansdale, PA, 19446
Posted:
May 07, 2010

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Resume:

Brenda M. Hertzog

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

215-***-****

Lansdale, PA 19446

abmu09@r.postjobfree.com

PROFILE

Associate Scientist with extensive experience in pharmaceutical and

clinical laboratories including over 10 years working in a regulated, GLP

structure. Career versatility demonstrated by knowledge and techniques in

the areas of Proteomics/Biomarker Discovery, Histology/Molecular Pathology

and Medical Technology. Managed and trained research associates in daily

laboratory operations. Developed and administered contracts involving the

out-sourcing of projects for assay development and analysis. Exceptional

organizational, troubleshooting, management and problem solving skills. MT

A.S.C.P. certified.

RESEARCH SKILLS AND TECHNIQUES

Protein Analysis Immunological Techniques

Enzyme - link immunosorbent assays Immunohistochemistry (single/doubles)

(ELISA)

Protein immunoblotting (western) Histological special stains

Protein isolation Immunohistochemistry Antibody

Pre-absorption

Immunoprecipitation In Situ Hybridization (ISH)

RNA purification Tissue Embedding / Processing / Microtomy

RT-PCR Cell Culture and Cell/tissue chip

Development

SELDI protein analysis (Ciphergen

ProteinChip ) Protein profiling, Ligand

fishing, protein-protein and

compound-protein interactions

PROFESSIONAL EXPERIENCE

Johnson and Johnson, Research and Early Development, Spring House, PA.

1999-2007

Associate Scientist - Target Validation Team (2003 - 2007)

Supported early development projects of therapeutic teams with assay

development and validation in biomarker discovery through the use of

protein based techniques such as western analysis, gel electrophoresis,

immunoprecipitation and ELISA. Managed a team of Research Associates in

Histology to support various therapeutic areas in drug development. Primary

contact that directly worked with legal department to develop quotes and

contracts with both commercial and private outside vendors in order to out-

source work for assay development and analysis. Over saw contacts to

ensure all specifications and time lines were achieved before any payments

were released. Accomplishments include:

Biomarker Discovery

. Developed and validated an ELISA and western protocol for the measurement

of cSLPI, a novel biomarker for chymase activity used in allergic

rhinitis and asthma clinical studies.

. Conducted Protein-Protein interaction studies, characterized receptor-

ligand binding to determine a potential ligand for orphan receptor to

develop it as a new drug target.

. Received Encore Gold Award (2006) for optimization and execution of the

cSLPI assay. Optimized the gel-based assay for the measurement of cSLPI

levels in laboratory and clinical samples along with the method of

collection of saliva samples using the OraSure technology.

MorphoMetric/Histology

. Independently coordinated the MorphoMetric /Histology area of the Target

Validation team by working with the team members to design novel methods

and procedures for incoming projects from various therapeutic teams along

with establishing and overseeing project priority, checkpoints and

timelines.

. Developed new histological procedures and protocols as needed to complete

projects while providing the necessary training to Research Associates to

perform these procedures.

. Worked one-on-one with project champions to help develop and design

scientific experiments to characterize/validate targets.

. Attended Therapeutic Team project meetings to understand the needs and

project objectives and offer insight on where histological techniques

could be used to further research and help obtain established goals.

. Involved in key projects, including Target Validation, Target

Characterization, Assay Development, Biomarker Development and Model

Confirmation.

Page 2 Brenda M. Hertzog

PROFESSIONAL EXPERIENCE - Continued

o Validated the effects of JNJ compounds on DSS induced colitis.

o Validated the efficacy of C1s inhibitor compounds in the rat

glomerular nephritis model.

o Evaluated numerous C-fms models (CIA, xenografts, glomerular

nephritise) and the efficacy of various FMS inhibitor compounds and

their effects on decreasing macrophages.

o Partnered with team project manager in the validation of the

arthrosclerosis model and development of best method to analyze the

levels of arthrosclerosis in the 15LO mouse model and observe the

effects of the agonist in this model.

o Validated high priority projects from other Johnson and Johnson

Research sites including the validation of the Oncology target in

various cancer tumors for Centocor which played a major role in

advancing the target in the pipeline.

o Provided key Histology/Target Validation support for the Metabolic

team involving characterization of a brain protein which lead to

discovering a novel distribution of this protein in other key

areas, defining it as a new drug target.

Research Associate - Target Validation Team (1999 - 2003)

Supported the site's Therapeutic teams through the use of histological

techniques which include processing, embedding, microtomy (paraffin and

frozen tissue), special stains, immunohistchemistry and in situ

hybridization

. Developed and launched the MorphoMetric Antibody

Database Search Engine, providing various J&J Drug

Discovery sites access to antibody information and

antibody tissue distribution.

. Received Impact Award (2001) for efforts in design and application of the

cell chip and constructing an antibody database search engine, which

could be accessed globally.

ST. LUKES HOSPITAL, Bethlehem, PA

1989 - 1999

Histotechnologist (1996 - 1999)

Trained as a Histologist and duties included Microtomy, Special Stains and

Immunohistochemistry all performed under regulated guidelines in the

hospital's Anatomic Pathology Laboratory. Gained experience in working on

an Automatic Microtome.

Medical Technologist (1989 - 1996)

Worked throughout the entire laboratory performing diagnostic tests through

the use of various automated clinical analyzers along with performing the

maintenance and quality control on the instrumentation to meet with

A.S.C.P. regulations and SOPs.

BLOOD BANK OF DELAWARE, Newark, DE

1985 - 1988

Medical Technologist

Responsibilities included typing, antibody screening, serological and

infectious disease testing of donor blood along with the preparation of

various blood components.

ALFRED I. DUPONT INSTITUTE, Wilmington, DE

1982 - 1984

Medical Technologist

Worked in every section of the clinical laboratory with direct

responsibility for the chemistry and microbiology departments.

Chemistry responsibilities included daily patient work-up, quality

control and instrument maintenance. As chief technologist in

Microbiology, handled the daily patient work-up and quality control

along with research projects requested by staff physicians and

surgeons. Reviewed use of new products in the laboratory and the

development of procedures to incorporate products into the daily work

schedule of the microbiology department.

MEDICAL DIAGNOSTIC LABORATORIES, Allentown, PA

1981- 1982

Medical Technologist

Worked throughout the entire laboratory and oversaw the hematology

department. Managed the laboratory, including quality control.

Page 3

Brenda M. Hertzog

EDUCATION

Bachelor of Science, Medical Technology, MILLERSVILLE STATE COLLEGE,

Millersville, PA

Internship, Allentown School of Medical Technology, Allentown, PA

ACCREDITATION

Registered with the American Society of Clinical Pathologists (MT - 144407)

- Medical Technologist

PUBLICATIONS

Manuscripts

1. Michael R. D'Andrea, Patti A. Reiser, Deborah A. Polkovitch, Norah A.

Gumula, Barbara Branchide, Brenda M. Hertzog, Danielle Schmidheiser,

Stanley Belkowski, Myriam C. Gastard, Patricia Andrade-Gordon. "The use

of formic acid to embellish amyloid plaque detection in Alzheimer's

disease tissues misguides key observations". Neuroscience Letters, 342

(2003) 114-118.

2. Michael R. D'Andrea, Patti A. Reiser, Deborah A. Polkovitch, Norah A.

Gumula, Barbara Branchide, Traci Williams-Riles, Danielle Schmidheiser,

Brenda M. Hertzog. "Application of collagenase on paraffin sections to

enhance Collagen IV immunohistochemical detection without distorting

tissue morphology". Biotechnic and Histochemistry, accepted 2003.

3. M. R. D'Andrea, Robert G. Nagele, Norah A. Gumula, Patti. A. Reiser,

Deborah A. Polkovitch, Brenda M. Hertzog, Patricia Andrade-Gordon.

"Lipofuscin and A-beta 42 exhibit distinction patterns in normal and

Alzheimer's disease brains". Neuroscience Letters 323 (2002) 45-49.

Book Chapter

Lou XJ, Belkowski SM, Dixon JM, Hertzog B, Horwitz D, Ilyin SI, Lawrence

D, Polkovitch D,Towers M, D'Andrea MR. Strategies of biomarker discovery

for drug development. Frontiers in Drug Design and Discovery, eds.

Caldwell, D'Andrea, 2006. Pp. 5-22



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