Education/Training

B.S., Biology ****

Northern Illinois University,

DeKalb, IL

Quality System Regulation

Annually 1985 -2002

OSHA Blood Borne Pathogen Annually 1985 -2000

Principles of Centered Leadership, July 1996

Statistical Process Control, May 1994

Design of Experiment, March 1994

Biologist with 30 years professional experience including over 10 years of successful project management experience.

Proven track record managing laboratory documentation including but not limited to laboratory reports, sample tracking, updating documentation systems, maintaining databases, historical documentation, product cell lineages, patents, and assays.

Expert in antibody evaluations including Chemiluminescent Immunoassay (CIA), Enzyme Immunoassay (EIA), Fluorescent Polarization Immunoassay (FPIA), Microparticle Enzyme Immunoassay (MEIA) and Radioimmunoassay (RIA).

Experienced in a variety of analytical techniques including, but not limited to, SDS PAGE, Western Blot, Isoelectric Focusing, FPLC with limited experience in HPLC.

Demonstrated knowledge and expertise in Current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) as well as state and federal laws and requirements.

Experience

Sales

Macy’s Gurnee, IL

October 2015 to Present

Promoted to Floor Manager Sept 2016

Supervision of employees

Customer complaint resolution

Opening and Closing store duties

Sales Associate

Customer relations

Cash Management

Credit Card promotion

Part-time Manager

Oberweis Dairy, Lake Zurich, Illinois

September2014 to April 2016

Responsible for the management and operation of Dairy Store/Ice Cream Parlor:

Opening and Closing store duties

Supervision of employees and shift labor

Cash Management

Customer Relations

Product Inventory and Quality

Project Scientist

St. John-Mittelhauser & Associates, Downers Grove, Illinois

January 2009 to December 2014

Responsible for the management and verification of laboratory documentation:

Established verification procedures for reports.

Verified incoming laboratory reports for litigation and Consent Decree compliance initiatives per Environmental Protection Agency (EPA).

Improved work processes for organizing historical data and reports to ensure audit trail that historical data and reports had been verified.

Responsible for reviewing Sample Tracking Tables and maintaining Air, Soil and Water Parameter Tables

for field samples.

Project Scientist

Bureau Veritas Downers Grove, Illinois

July 2003 to December 2008

Responsible for the management and verification of laboratory documentation:

Established verification procedures for reports.

Verified incoming laboratory reports for litigation and Consent Decree compliance initiatives per Environmental Protection Agency (EPA).

Improved work processes for organizing historical data and reports to ensure audit trail that historical data and reports had been verified.

Responsible for reviewing Sample Tracking Tables and maintaining Air, Soil and Water Parameter Tables

for field samples.

Monoclonal Antibody Development

Abbott Laboratory, Abbott Park, Illinois

March 1997 to August 2003

Senior Project Manager and Departmental Training Coordinator with responsibilities for the following:

Updating documentation of Research and Development (R&D) experiments for compliance with current Standard Operating Procedures (SOP’s)

Providing the necessary documentation and organization so R & D produced material was traceable.

Ensure R & D produced material was approved for use in Current Good Manufacturing Practices (cGMP) facilities.

Successfully integrated departmental staff to an electronic documentation system from a manual notebook system.

Participated in Consent Decree compliance initiatives, researched historical documentation to trace product cell lineages from establishment/procurement in R&D to manufacturing.

Collaborated with Corporate Records to ensure complete and accurate documentation of Diagnostic Test Reagents for Device History Files per Federal Drug Administration (FDA) directive.

Responsible for sourcing, procurement and evaluation of outside vendor antibodies for various assay platforms. Antibody evaluations consisted of Chemiluminescent Immunoassay (CIA), Enzyme Immunoassay (EIA), Fluorescent Polarization Immunoassay (FPIA), Microparticle Enzyme Immunoassay (MEIA) and Radioimmunoassay (RIA).

Created and maintained departmental antibody, assay and patent databases, conducted patent searches for all departmental projects, practiced GLP (Good Laboratory Practices) and maintained complete documentation in accordance with cGMP policies.

Clinical Chemistry TPD

Abbott Laboratory, Abbott Park, Illinois

March 1996 to March 1997

Responsible for the investigation of customer complaints, performed CAP surveys and ARCHITECT ® Clinical Chemistry feasibility studies.

Practiced GLP, cGMP and maintained complete and accurate documentation in accordance with cGMP policies.

Monoclonal Antibody Development

Abbott Laboratory, Abbott Park, Illinois

July 1985 to July 1995

Project Manager with responsibilities that included:

Development of monoclonal antibodies for use in various diagnostic assays and platforms. This included the development of immunization protocols, assay development and monoclonal cell line establishment.

Proficient in EIA, FPIA and RIA development and optimization, routinely used FPLC and occasionally used HPLC methods for affinity and size exclusion chromatography of proteins and antigens. The analytical techniques employed included SDS PAGE, Western Blot and Isoelectric Focusing.

Developed extensive expertise in tissue culture, small animal surgery and immunizations. Practiced GLP and maintained complete and accurate documentation in accordance with cGMP policies.

Publications and Presentations

Development of Quantitative Vancomycin Immunoassay for the Abbott AxSym® Analyzer. (Therapeutic Drug Monitoring 20:191-201)

Patents

Reagents and Methods for the Detection and Quantification of Thyroxine in Biological Fluids. (Five US Patents, One European Patent)

Reagents and Methods for the Detection and Quantification of Vancomycin in Biological Fluids. (One European Patent, One US Patent

Community Involvement

School District 95, Lake Zurich IL

September 2003 to May 2014

Various PTO Volunteer positions at Seth Paine and Middle North Schools

Room Mother at Seth Paine for 3 years

Teacher assistant for 5 years

Annual Plant Sale Chairperson at Seth Paine for 7 years

PTO President at Seth Paine for 2 years

Chaired Annual No Stress Fundraiser at Middle School North for 3 years and raised over $35K

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