RENAY A. EBELLE
5 Witherwood Drive, Hamburg, NJ 07419
Cell:  [Send email to request phone number] 07.6220 Phone:  [Send email to request phone number] 09.9767

SUMMARY

Senior Executive combines technical, regulatory, project management and business
experience to build businesses and relationships to deliver new products to
market. Over 15 years experience in pharmaceutical, biologics, diagnostic and
medical device development, including In-Vitro Diagnostic, with market leaders
such as Johnson & Johnson, Watson Pharmaceuticals and Electro-Optical Sciences
Inc.. Led worldwide clinical trials and R&D programs. Well-organized problem
solver and decision-maker, evaluates resources and prioritizes responsibilities
to achieve objectives.

 * 510(k)/IDE/PMA
 * FDA/MDD/ICH/EMEA
 * Pharmaceuticals / Biologics / Diagnostics / Medical Devices
 * Retrovirology
 * Oncology
 * Immunology
 * IND/NDA/BLA

PROFESSIONAL ACCOMPLISHMENTS

Regulatory and Quality Assurance
 * Led new product development of wide variety of FDA-regulated products,
domestic and international clinical trials and regulatory submissions, as well as
customer-focused Sales and Marketing activities.
 * Corporate Regulatory strategy. Preparation of pre-IND, IND and NDA, 510(k),
IDE, pre-PMA package and PMA applications, development of quality systems to
support CGMP (CFR 210 / 211 CFR 820), EMEA, ICH, GCP, ISO and MDD.
 * Extensive experience in design control, drug therapy, clinical trial
methodology, drug development process, clinical auditing, and Chemistry
Manufacturing and Control. Drug development includes: pre-formulation,
specifications development, QC, stability and manufacturing oversight for API and
pharmaceutical products.
 * Process / product development and validation, quality assurance, regulatory
compliance and post-market vigilance.
 * Directs cross-functional and cross-company teams to develop and commercialize
new medical products, ensure effective drug safety data collection, and timely
reporting of data collected in clinical trials.

Program Management
 * Project management professional with unique blend of technical, regulatory
and business experience.
 * Lean six sigma process expertise.
 * Green Belt professional for process excellence.

R&D and non-Technical Interfaces
 * Created and fostered relationship "bridges" between technical community and
all other company divisions, especially Sales and Marketing, resulting in
customer focused product design.
 * Chaired design control for class II and III medical device. Managed custom
software development and validation process for class III devices.

External Relationship Management
 * To achieve and maintain dominant market position, built and strengthened
relations with national and international regulatory authorities, suppliers,
research partners, contract manufacturers, distribution and archive vendors.
 * Strong scientific links and collaborative studies with opinion leaders
globally in field of Infectious Diseases, enhancing market advantage.

Business Start-Up
 * Started new technical business from ground up, including regulatory
approvals, and product launch.
 * For start-up biotechnology companies: Design, development and implementation
of quality system to meet GXP, QSR 820, ISO and company's objectives. Proven
record of streamlining products from research to regulatory approval (US / Canada
/ EU / Japan / Australia) and to early market entry. Product / process and
regulatory strategy development and management.

RENAY A. EBELLE PAGE TWO

PROFESSIONAL EXPERIENCE

ELECTRO-OPTICAL SCIENCES INC., Irvington, NY 2007 - Present
Head of Quality, Director Quality Assurance & Regulatory Affairs- Compliance
Officer

TYRX PHARMA INC., Monmouth, NJ 2005 - 2007
Senior Manager Quality Assurance / Quality Control / RA

CORDIS LLC, Johnson & Johnson Company, Warren, NJ 2003 - 2005
Senior Regulatory and Quality Consultant

WATSON PHARMACEUTICALS, Salt Lake City, UT 2003 - 2003
Regulatory Compliance and Quality Assurance -Validation

ELUSYS THERAPEUTICS INC., Pine Brook, NJ 1999 - 2002
Manager, Analytical and Characterization Group - QC - Product Development
Department

ORTHO CLINICAL DIAGNOSTICS INC./ Johnson & Johnson, Raritan, NJ 1996 - 1999
Scientist III, Quality Control / Quality Assurance - Process Engineering &
Virology Departments

COLUMBIA PRESBYTERIAN MEDICAL CENTER, Columbia University, New York, NY 1993 -
1995
Research Associate, Cellular and Molecular Immunology

EDUCATION

PhD, Microbiology-Immunology- Biochemistry Department, Columbia University, New
York, NY, (PhD program)
MS, Biochemistry, National University of Ivory Coast, Abidjan, Ivory Coast
BS, Biochemistry, National University of Ivory Coast, Abidjan, Ivory Coast

Six Sigma & Lean Manufacturing Certificate, Lockheed Martin, NJ, 2006
Project Management Certificate & Quality Assurance Training, Rutgers University,
Business School, NJ, 2006
Green Belt Professional for Process Excellence, Rutgers University, Business
School, NJ, 2006
ISO13485 & ISO9001 Certified Auditor, Excel Partnership Inc, 2005

COMPUTER LITERACY

 * Microsoft Project
 * Excel
 * Access
 * Microsoft Visio
 * Oracle (UNIX)
 * DOE Pro
 * Microsoft Publisher
 * Minitab
 * SPC-XLS

OTHER LANGUAGES

French: Fluent in both written and spoken expression