Shonna Riedell (Fleck)

**** **** *****, *********, ** 42301

270-***-****, ac0g8r@r.postjobfree.com

EDUCATION:

Masters of Business Administration, 2005 Bachelors of Arts, 1994

University of Phoenix, San Diego, CA Southern Illinois University, Carbondale, IL

Emphasis: Technology Management Major: Microbiology

EXPERIENCE:

SENIOR RESEARCH TECHNICIAN

Owensboro Cancer Research Program

University of Louisville, Louisville, KY

October 2007-present

QA audits for GLP, GMC and GCP laboratories.

Establish GMP laboratory for the manufacturing of potential HIV microbicide vaccines to enter Phase 1 clinical trials.

Serve as the professional liaison between trial sites, manufacturing facility, IRB, and University of Louisville.

Assist in the site activation for trials.

Write and revise SOPs.

Guide and supervise junior technicians and student interns.

Write and present research reports, protocols, and manuscripts.

Maintain regulatory documentation.

QC of incoming samples and documentation.

Create and maintain chemical and equipment logs.

Ensure all personnel are current in training and documentation.

Maintenance of equipment certifications.

Catalog samples into a database.

Responsible for training of all employees, interns, student workers, and principal investigators within the facility on tissue/cell culture, in vitro experiments, FACS, and microscopy.

DNA manipulations to produce broadly cross neutralizing HPV L2 vaccines.

Utilize and optimize potential vaccine production with Nicotiana tobacum.

Specialize in plant made pharmaceutical (PMPs) of various lectins as highly effective anti-virals.

Analyze and compare vaccine production using various platforms.

Establish and manage a flow cytometry core facility.

Develop and optimize viral assays utilizing HIV and HPV for high through put testing of potential vaccines for specificity and efficacy.

Optimize imaging of various tissues and cells utilizing confocal and fluorescent microscopes. Several of these images have been used in publications.

Establish a system for high through put manufacturing of monoclonal antibodies.

Certified flow operator through Becton Dickinson.

REGULATORY AFFAIRS COORDINATOR II

Covance Clinical Research Unit, Inc., Evansville, IN 47714

January 2006- January 2007

Maintain all regulatory documents for the Evansville site.

Submit regulatory documentation to IRB and FDA.

Internal QC audits of clinical studies.

Develop systems and controls to ensure GCP compliance with regulatory documentation.

Solved issues and resolved concerns that may arise in regards to essential study documents.

Provided a professional liaison for investigator-to-sponsor and investigator-to-IRB communications.

Managed the regulatory document files of multiples studies in various stages at any given time.

Prioritized multiple tasks in order to meet time requirements from various sources.

Made presentations to both internal and external customers regarding regulatory issues.

Kept current of changes in federal and international regulations and guidance documents applicable to clinical research trials.

GROUP LEADER/ SUPERVISOR

Inova Diagnostics, Inc., San Diego, CA 92131

July 2001-February 2003

Supervise the slide manufacturing department personnel with up to 20 direct reports.

QA/QC inspection and auditing of in process and final products.

Maintain records according to GMP and GCP regulations.

Quality control of manufacturing practices and procedures.

Write and edit product information documents.

Conflict management and dispute resolution among department employees.

Coordinate collaborative efforts between groups and with other companies.

Write and revise SOPs.

Technical expertise on cell culture.

Organization of tasks.

Assignment of duties and scheduling of personnel within the manufacturing department.

Present group laboratory meetings and to various departments.

Train new employees.

Participate in employee evaluations.

RESEARCH TECHNICIAN III

The Scripps Research Institute, La Jolla, CA 92137

August 1994 – July 2001

Manipulations of viral DNA using Adeno and Adeno Associated viruses for gene therapy. Dr. Glen Nemerow laboratory.

Assist with In vivo and In vitro assays to study T-cell tolerance and auto immunity. Dr. Linda Sherman laboratory.

PUBLICATIONS:

1.Morgan, David, R. Liblau, B. Scott, S. Fleck, H. McDevitt, N. Sarvetnick, D. Lo, and L.A. Sherman. CD8+ T-Cell Mediated Spontaneous Diabetes in Neonatal Mice. The Journal of Immunology. 1996, 157: 978-983.

2.Morgan, David, H. Kreuwel, S. Fleck, H. Levitsky, D. Pardoll, and L.A. Sherman. The Effects of Tolerance on Rejection of Tumor Cells Expressing Self- Antigen. The Journal of Immunology. 1998, 160: 643-651.

3.Von Seggern, Dan, C. Chiu, S. Fleck, P. Stewart, and G.R. Nemerow. A Helper-Independent Adenoviral Vector Deleted for E1, E3, and Fiber: Structure and Infectivity of Fiberless Particles. The Journal of Virology. 1999, 73: 1601-1608.

4.Von Seggern, Dan, S. Huang, S. Fleck, S. Stevenson, and G.R. Nemerow. A Pseudotyped Adenoviral Vector Allows More Efficient Transduction of EBV-Transformed B Cells. The Journal of Virology. 2000, 74: 354-362.

5.Wu, Eugene, J. Fernandez, S. Fleck, D. Von Seggern, S. Huang, and G.R. Nemerow. A 50-kDa Membrane Protein Mediates Sialic Acid-Independent Binding and Infection of Conjunctival Cells by Adenovirus Type 37. Virology. 2001, 279: 78-89.

6. Von Seggern, Dan, H. Anguilar, K. Kinder, S. Fleck, S. Stevenson, M. Friedlander, and G.R. Nemerow. In VivoTransduction of Photoreceptors or Ciliary Body by Intravitreal Injection of Pseudotyped Adenoviral Vectors. Molecular Therapy. 2003, 7: 1-8.

7. Kouokam JC, Huskens D, Schols D, Johannemann A, Riedell SK, et al. (2011) Investigation of Griffithsin's Interactions with Human Cells Confirms Its Outstanding Safety and Efficacy Profile as a Microbicide Candidate. PLoS ONE 6(8): e22635. doi:10.1371/journal.pone.0022635

8. Dalia Larios, Zhong Huang, Jackie Kilbourne, Khan Piensook, Hyun Soon Kim, Shonna Riedell, Kenneth Palmer, Hugh Mason. Immunogenicity in mice of human papillomavirus L2 capsid protein N-terminal region fused to hepatitis B core virus-like particle, a potential vaccine against HPV. In press.

9. Fuqua, Joshua, Riedell SK, Lasnik AM, and Palmer KE. A Broadly Cross Neutralizing Response Generated by L2 RG1 peptide conjugated to Streptavidin Across several species. In press.

10. Fuqua, Joshua, Riedell SK, Lasnik AM, Walker JM, and Palmer KE. Non Glycosylated Colera Toxin Subunit B Provides potential as a vaccine when Conjugated with L2 subunit of Human Papillomavirus L2 capsid protein. In prep.

REFERENCES:

Dr. Kenneth Palmer

Director of Owensboro Cancer Research Program, University of Louisville, 502-***-****

Scott Sells

Senior Business and Technology Consultant, Eli Lilly and Company, 317-***-****

Dr. Huub Kreuwel

Vice President US Medical Affairs, Octapharma, 270-***-****

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