Manager Project
Resume:
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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