RENAY A.

EBELLE
5 Witherwood Drive, Hamburg, NJ 07419
Cell: 973.207.6220 Phone: 973.209.9767
SUMMARY
Senior Executive combines technical, regulatory, project management and business
experience to build businesses and relationships to deliver new products to mar
ket. Over 15 years experience in pharmaceutical, biologics, diagnostic and medic
al device development, including In-Vitro Diagnostic, with market leaders such a
s Johnson & Johnson, Watson Pharmaceuticals and Electro-Optical Sciences Inc.. L
ed 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, domest
ic and international clinical trials and regulatory submissions, as well as cust
omer-focused Sales and Marketing activities.
* Corporate Regulatory strategy. Preparation of pre-IND, IND and NDA, 510(k), I
DE, pre-PMA package and PMA applications, development of quality systems to supp
ort CGMP (CFR 210 / 211 CFR 820), EMEA, ICH, GCP, ISO and MDD.
* Extensive experience in design control, drug therapy, clinical trial methodol
ogy, drug development process, clinical auditing, and Chemistry Manufacturing an
d Control. Drug development includes: pre-formulation, specifications developmen
t, QC, stability and manufacturing oversight for API and pharmaceutical products
.
* Process / product development and validation, quality assurance, regulatory c
ompliance 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 an
d 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 a
ll other company divisions, especially Sales and Marketing, resulting in custome
r focused product design.
* Chaired design control for class II and III medical device. Managed custom so
ftware development and validation process for class III devices.
External Relationship Management
* To achieve and maintain dominant market position, built and strengthened rela
tions with national and international regulatory authorities, suppliers, researc
h partners, contract manufacturers, distribution and archive vendors.
 * Strong scientific links and collaborative studies with opinion leaders global
ly 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 rec
ord of streamlining products from research to regulatory approval (US / Canada /
EU / Japan / Australia) and to early market entry. Product / process and regula
tory 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 Off
icer
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 Depart
ment
ORTHO CLINICAL DIAGNOSTICS INC./ Johnson & Johnson, Raritan, NJ 1996 - 1999
Scientist III, Quality Control / Quality Assurance - Process Engineering & Virol
ogy Departments
COLUMBIA PRESBYTERIAN MEDICAL CENTER, Columbia University, New York, NY 1993 - 1
995
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 Sch
ool, 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