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Quality Control

Kenosha, WI, 53142
August 31, 2012

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

Kenosha, Wisconsin 53142



Scientist with extensive experience in biologics process development, antigen/antibody purification development and validation. Strong analytical and troubleshooting skills that contribute to proactive solutions, process improvement initiatives and cost effective operations.

Expertise in:

• Team Leadership

• Training

• Regulatory Compliance

• Quality

• Research and Development

• Test Methodology


ABBOTT LABORATORIES, Abbott Park, IL 2000 to Present

Biologics Process Development Scientist 2001 to Present

Responsible for research and development of purification processes for proteins used in diagnostic assays; test method development and validation.

• Developed chromatography (SEC, IEX, and Affinity) and chemical washing purification processes for new antigens/antibodies including HIV, HCV, HBV, HTLV, and Chagas for diagnostic assays. Characterized and validated purification processes for 510K, PLA/BLA, and CBER licensure, successfully meeting quality requirements and product launch timelines.

• Investigated manufacturing process failures and initiated process improvements utilizing CAPA systems to expedite resolution and ensure product availability.

• Determined appropriate identification and purity testing for purified proteins through effective use of HPLC methodologies, SDS-PAGE Densitometry and Western Blotting techniques. Characterized and validated analytical performance characteristics of testing to ensure compliance with cGMP standards.

• Conducted training and mentored staff on large scale column packing and use, protein purification processes, and test method techniques, enhancing skills needed to ensure efficient processes during manufacture and reduce costs.

Validation Remediation Scientist 2000 to 2001

Responsible for characterization and statistical analysis of platform assay test methods using IMx/TDx/AxSYM and validation package development.

• Developed characterization protocols for diagnostic kits and performed data analysis utilizing JMP application, providing documentation needed to interpret trends and set validation specifications.

• Conducted capability analysis of test methods to assess manufacturing specifications and ensure consistency of operations.

• Wrote characterization reports that included critical quality attributes, process specifications and controls needed to develop validation protocols for Digoxin IMx, Carbamazepine TDx, and Procainamide TDx.

• Acted as Validation Initiator for Carbamazepine TDx Test Method and coordinated cross-functional teams during test method validation process, providing documentation needed to assess any failure investigation of invalid testing runs.

RED STAR YEAST, Milwaukee, WI 1999 to 2000

Microbiology Quality Control Laboratory Technician

Responsible for pathogenic organism testing on raw materials, finished products, and processing machinery.

• Performed microbial sampling and organism identification testing on Vitek Vidas systems to ensure product quality and compliance with FDA regulations.

OLSTEN STAFFING, Racine, WI 1998 to 1999

SC Johnson - Microbiology Laboratory Technician

Responsible for new product and technology R&D for antimicrobial consumer products. Performed microbial sampling and organism identification testing to ensure product quality.


BS, Cell and Molecular Biology, Minor, Biochemistry Winona State University, Winona, MN

Graduated Cum Laude


High Performance Liquid Chromatography (HPLC)

Liquid Chromatography (Gel Permeation, Size Exclusion, Affinity and Ion-Exchange)

Polyacrylamide Gel Electrophoresis and multiple staining techniques

Blotting: Western, Northern, Southern

Protein Purification Techniques

Polymerase Chain Reaction (PCR)

Cell Culture

Monoclonal Antibody Production

DNA Cloning


PC Hardware Configuration, Excel, Word, Power Point, Visio, JMP, Win9X, WinXP, Win7, DOS

Design of Experiments

Statistical Analysis


United States Presidential Scholarship, Winona State

TRI-BETA Fraternity (Biological Honors Society)

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