EXPERIENCE:

Sigma-Aldrich, **** *nd street, St. Louis, MO 63118

June 2006 to March 2011, QC Chemist II/Statistician (Sigma Direct Employee)

Supervisor: Phil McCullough 314-***-**** ext. 4110

Responsibilities:

• Review and advise on technical as well as ICH, EP, and USP guidelines and monographs.

• Review data and provide laboratory support to cleaning validation, method validation, stability, release, and method development groups as needed.

• Provide statistical analysis and trending projections to set product specifications and expiration dates.

• Design calculation templates and forms with VBA macros to support specific needs with smart documents

• Write operating procedures, protocols, and reports for method validations and stability studies.

• Planned validation studies and participated on various problem solving committees.

Sigma-Aldrich, 3300 2nd street, St. Louis, MO 63118

March 2006 to June 2006, QC Technical Writer (Kelly Scientific contract)

Supervisor: Phil McCullough, 314-***-**** ext. 4110

Responsibilities:

• Write operating procedures, protocols, and reports for method validation studies.

• Review regulatory requirements and advise on validation guidelines.

Pfizer, 645 S. Newstead Avenue, St. Louis, MO 63110

September 2004 to September 2005, Regulatory Affairs Associate (Manpower Professional contract)

Supervisor: Todd Meyer, 636-***-****

Responsibilities:

• Supported the conversion of several localized document management systems to a single global EDMS (Documentum) system, by assisting various groups in the conversion of hardcopy archives to an electronic storage system.

• Classified various documents related to drug manufacturing and created metadata to assist search engines.

• Tracked the progress being made on the conversion effort.

Monsanto Company, 800 N. Lindbergh Blvd., Creve Coeur, MO 63167

February 1998 to December 2003, Protein Biochemist/Study Director (Monsanto Direct Employee)

October 1992 to February 1998, Research Technician/Principal Investigator (Today’s Temporary contract)

Supervisor: Richard E. Goodman, 402-***-****

Accomplished Tasks:

• Supported the Product Characterization and Safety Center within Regulatory Science to assess the safety of genetically modified crops through molecular and protein research.

• Managed safety studies that were submitted to regulatory agencies to gain market approval of genetically modified crops, such as Bollgard Cotton, Roundup Ready Wheat, and Yieldgard Corn.

• Highly knowledgeable of allergen pre-screening measures, and directly experienced in the validation of digestion models for risk assessment. Advised researchers on potential new products by providing risk assessments.

• Participated in a scientific outreach program, which advised and trained international guests on biotech methods and approaches to making safety assessments on genetically modified products. Familiar and comfortable with diverse teams and global issues.

• Validated in vitro assays.

• Developed ELISA and Western blot methods, and performed several laboratory methods including Southern blot, Amino acid composition analysis, SDS-PAGE, cell lysis, and protein purification support.

• Reviewed mass spectrometry, amino acid composition and other data for quality assurance and compliance to regulatory requirements on documentation.

• Contributed to and authored numerous internal documents, including procedures, forms, policies, and reports.

• Set-up databases, to track related studies and ergonomic evaluations, and created a central location for information, which supported all personnel to fully access resources such as service contacts, and locations of equipment and supplies.

• Created analytical templates for point-to-point, linear and quadratic regression analyses.

• Presented a poster at the 40th Conference for the Society of Toxicology, San Francisco, CA 2001

• A list of external publications is available upon request.

St. Louis Community College at Meramec, 11333 Big Bend Blvd., Kirkwood, MO 63135

January 1991 to July 1992, Mathematics Tutor

Accomplished Tasks:

• Increased students’ understanding of mathematical concepts, within a drop-in center format, by providing new perspectives at looking at the problem and giving assistance with homework examples

• Gave structure to students in a self-paced program by providing training on a routine individual basis

EDUCATION:

• Bachelor of Arts in Biology from University of Missouri in St. Louis

• Associate of Arts in Mathematics from St. Louis Community College at Meramec

• Associate of Arts in General Studies from St. Louis Community College at Meramec

• Certificate of Completion in EMT from Institute of Health Management

• A total of 153 undergraduate credits, G.P.A. 3.4, and currently pursuing a Master of Science degree in Computer Information Systems through University of Phoenix, G.P.A. 3.9 and 25 credits to date. Studies include programming management, application development lifecycles and testing, and more.

TRAINING:

Corporate training courses and certifications (a more detailed list is available)

• GMP Concepts, November 2004

• 21 CFR Part 11 Awareness, November 2004

• Access 2000 Introduction, July 2003

• Statistics for Experimenters, September 2000

• Operation of Hitachi Amino Acid Analyzer L-8800, July 2000

• Various Study Director training sessions

• Various training sessions on Good Laboratory Practice standards

• Various annual safety courses including instructions for handling radioactivity and blood pathogens

MEMBERSHIPS:

• ACS active membership 2008.

• RAPS active membership 2005.

AWARDS:

• $1000 Above and Beyond Award from Monsanto Company, October 2001

• Various peer recognition awards

QUALIFICATIONS:

Laboratory skills (not all inclusive):

• Quantitative analysis of scanned digital images, stained gels, and x-ray film images

• ELISA (Direct and Indirect, quantitative and qualitative)

• Western blot (ECL, AP, 125I) and Southern blot (32P)

• DNA isolation by CsCl gradient

• Protein assays (Bradford, Biurett, BCA, Lowry, UV)

• Enzyme assays (EPSPS, pepsin, pancreatic enzymes)

• Insect bioassays (Diet overlay or incorporation for Colorado Potato Beetle, Corn Root Worm, others)

• Amino acid composition analysis (Hitachi L-8800)

• Cell culture and fermentation

• Protein extraction and characterization (e.g. concentration, purity, glycosylation)

• Protein studies (soil degradation, heat stability, digestibility, equivalence, virus transfection)

• Protein purification (ion-exchange chromatography, nickel column, salting out, affinity purification)

• GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) trained

• Thin Layer Chromatography

• Atomic Absorption

• Validation studies (Based on ICH and USP guidelines)

Computer skills:

• Visual BASIC, VBA, SQL, FORTRAN, some C, Windows and UNIX

• SAP, Adobe Photoshop, Documentum, eDoc, Insight, TeamTrack, eDoc, Livelink, Snag IT, and others

• Microsoft Office (Windows, Excel, PowerPoint, Word, Access, Outlook, Lotus Notes)

• Macintosh (WordPerfect, MacDraw Pro, Cricket graph)

• Various lab equipment software (including SoftPro Max, Deskscan II, KC4, Quantity One)

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