KUMRU E.

KASTRO

925 Francine Drive, Cherry Hill, NJ 08003

Residence: (856) 914-0934
Email: kumru.kastro@rutgers.edu, kumrunj@yahoo.com
Molecular Biologist with over 10 years of diverse experience in the following areas: Regulatory Affairs, Health
Economics, Research and QA/GMP for the pharmaceutical companies. Result oriented, detailed and analytical approach
for every project, with excellent communication skills.
PROFESSIONAL EXPERIENCE
CAMDEN COUNTY COLLEGE, MATH, SCIENCE AND HEALTH CAREERS, Camden, NJ
Adjunct Professor
(08/2005-Present)
Teaching in the Biology Department-Health Sciences Division, for two sections of Biology I. and Bio II

RUTGERS UNIVERSITY, LIBRARY OF SCIENCE AND MEDICINE, New Brunswick, NJ

Unit Admin Information Assistant
(09/2015-01/2016)
Directors assistant for a specific project. Teaching Research Methods within university databases and resources
for science undergraduates.
CAMDEN COUNTY COLLEGE, Rohrer Campus, E-Library, Cherry Hill, NJ
E-Library: Library Assistant.
(08-12/2014)
BURLINGTON COUNTY COLLEGE, MATH, SCIENCE AND HEALTH CAREERS, Camden, NJ
Adjunct Professor
(08/2007-05/2008)
Teaching in the Biology Department-Health Sciences Division, for two sections of Biology I. and Lab for Bio I.

JANSSEN-CILAG / JOHNSON & JOHNSON PHARMACEUTICALS, Istanbul, Turkey

Regulatory Affairs & Pricing Manager
(1998-2001)
Responsible for obtaining Marketing Authority and Re-imbursement of pharmaceutical products. Product line:
Oncology, GI, dermatology, CNS, infectious diseases.
Established Regulatory Affairs Department within the company. Reported to General Manager and Area Director of
Regulatory in Antwerp, Belgium. RA Department members 1 Pharmacist, 1 Chemical Engineer, 1 Secretary was
reporting to me.
Successfully completed over 50 file submissions according to European Registration Regulation, including registration
transfers from the local license holder company.
Successfully registered over 20 pharmaceutical products, and over 10 new product launches.
First to implement Fast-Track Registration in Turkey for Durogesic (narcotic analgesic); registration period took
only 4 months, compared one year according to the newly implemented regulations and conditions.
Implemented recall process for Prepulsid (worldwide decision), successfully convinced the local Health Authority
(MoH) so the registration was not cancelled in Turkey. Only couple of countries including Turkey gained success
from the current conditions.
Prepared a draft version of a new reimbursement guideline utilizing all new aspects of the reimbursement channels for
Turkish Health Authority.

MERCK (Former ORGANON), Istanbul, Turkey

Registration Manager
(1997-1998)
Responsible for obtaining Marketing Authority and Re-imbursement of pharmaceutical products. Product line: HRT,
CNS.
Reported to General Manager and Area Director of Regulatory in Oss, The Netherlands. RA Department members, 1
Chemical Engineer, 1 Business Administrator was reporting to me.
Represented the company on regulatory and QA compliance studies through the toll manufacturers.
Part of the Training team of the Sales Force.
Successfully received approval for the registration renewals of current 20+ products according to the European
Registration Regulation.
Organized the first manufacturing batch of Remeron (CNS product) with the toll manufacturer.

GLAXOSMITHKLINE, (Former Wellcome / GlaxoWellcome), Istanbul, Turkey

Registration Manager
(1992-1997)

Responsible from the pharmaceutical products under the license of The Wellcome Foundation. Product line: OTC,
infectious diseases especially Anti-virals, oncology, anesthesiology, orphan drugs, CNS.
Reported to Medical Director, and Central Regulatory Division Director in Beckenham, UK. Established Regulatory
Affairs department within the local Wellcome Company, local. RA Department Members 1 Pharmacist, 1 Secretary
was reporting to me.
70+ file submissions and registration, 80+ new product launches completed.
First to submit a Phase IIIB clinical trial file (Lamictal) with compliance to GCP.

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First to set up MS Project computer program, for the efficient interaction of Regulatory, Logistics, and Marketing
Departments. Program is still in use by the management of GSK Turkey.
Registered 4 products in the former Soviet Union.

BECTON DICKINSON USTAY MEDIKAL, Istanbul, Turkey

Quality Assurance / Quality Control Manager
(1987-1992)
Responsible for the QC/QA and the registration of the medical disposable products through the Standards Institute and
Local Health Authority; application of GMP in all levels of manufacturing.
Product line: Disposable medical devices - syringes.
Reported to General Manager. Managed 11 people (1 Chemical Engineer, 3 Biologist, 6 Chemical Technicians, 1
Secretary). Established QC/QA department within the company.
Originated SOPs and implemented them to manufacturing /QA processes of the disposable medical products
according to the current TSE, DIN (German Standards) forms.
Created a Continuing Training Program of the Sales Force and Manufacturing group according to GMP guidelines.
Established the first accredited QA laboratory certified by (TSE) local institute of standards and Health Authority.
Invited to attend Association Francaise pour la Qualite (French Quality Association) (AFCIQ) meetings.

TUBITAK (Scientific and Technical Research Council of Turkey), Research Institute for Basic Sciences,
Department of Genetic Engineering and Biotechnology
Research Assistant/Scientist
(1983-1986)
Responsible for pure scientific research in biotechnology and preparation of publications for institute.
Selected to create a team establishing the first biotechnology research lab and contributing to the studies.
Earned two competitive scholarships and fellowships.
Co-authored 7+ scientific publications nationally and internationally.

EDUCATION

Master of Information candidate at School of Communications, Rutgers University, New Jersey, USA. Graduate
12/2016.
Completed couple of courses towards QA/RA Certificate Program in 2005 at School of Pharmacy, Temple University,
PA, USA and couple of courses towards Ph.D. program in Microbiology in 1987 at University of California Davis,
USA.
M.Sc., Biotechnology/Biochemistry, 1986, Hacettepe University, Ankara-Turkey
B.S., Biology, 1982, Ankara University, Ankara-Turkey

MAJOR TRAINING AND CONFERENCE ATTENDANCE

MLA: Austin, TX 2015,

ALA Mid-Winter: Boston, MA 2016, Chicago IL 2015, Philadelphia, PA 2014., Charleston Conference, Charleston,
SC 2014
ALA- Annual: Las Vegas 2014, Chicago, Il, 2013.
ATE-Genomic Approaches in BioSciences Workshop, UK-Cold Spring Harbor Laboratories, Lexington, KY., July 913, 2012.
The Silencing Genomes RNAi Follow-up Workshop, Howard University- Cold Spring Harbor Laboratories and NSF,
Washington, D.C., June-July, 2010.
iPlant for Faculty, The Rockefeller University-Cold Spring Harbor and NSF New York City, New York, 6/ 2010.
International Summer Symposium on Biofuels and Bioenergy, Rutgers-NSF IGERT Project, New Jersey, 06/2010
Silencing Genomes, Cold Spring Harbor and NSF, Washington DC, 08/2009
Health Economics and Pricing, London School of Economics, London, UK, 2001
A Passion of Pricing, J&J, Istanbul, Turkey, 2000
Team Building and Development, J&J / Baltas, Istanbul Turkey, 2000
Standards of Leadership & Credo Values, J&J, Cairo Egypt, 1999
Introduction to Pricing of Pharmaceuticals, J&J, Belgium, 1998
How to transfer clinical trial data to the package leaflet language. Organon, The Netherlands, 1998
Personal Relations and Management, GlaxoWellcome / Bogazici University, Istanbul Turkey, 1996
Presentation Skills, The Wellcome Foundation Ltd., London /U.K., 1994
Good Clinical Practice (GCP) Training, The Wellcome Foundation Ltd., London/UK, 1994
Participant of the study groups for the drafts of ISO 9000 series of standards, AFCIQ, Paris/France 1989
QC/QA Training for Medical Disposables. Berlin Institute and BD, Germany, 1987

PUBLICATIONS

IRB Approval (CCC-10/12/2011) Research Title: Functional Genome Analysis by RNA: Phase II Curriculum
Dissemination and Evaluation.

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A screening procedure for detecting cellulolytic fungi by using Congo red as an indicator: A comparative study with
the dinitro salicylic acid reagent method. A.Sazci, K.Erenler, DOGA, TU Bio. D.C. Nisan 1987
Detection of cellulolytic fungi by using Congo red as an indicator: A comparative study with the di nitro salicylic acid
reagent method. A.Sazci, A.Radford, K.Erenler, Journal of Applied Bacteriology 61, 624-633, 1986
A method for the isolation of DNA from various fungal mycelia. A.Sazci, K.Erenler, DOGA, TU Bio, D.C. 10 S 3,
510-514, 1986
Seluloz, Selulaz ve Genetigi. A.Sazci, K.Erenler, H.Yuce, DOGA,TU Bio D.C. 10 S 3, 499-509, 1986.
M.Sc. Thesis: Preliminary work on cloning cellulase genes of Trichoderma reesei QM 9414. Hacettepe University,
1985, Ankara Turkey

PROFESSIONAL ACTIVITIES
Chair: By-Laws, for the Philadelphia-Regional Chapter of MLA Board (05/2016-Present)
Volunteered for Library at Philadelphia Veterans Hospital, PA. (09/2015-01/2016)
Science Fair Judge: Coriell Institute (2010-2014), Bridgeton (2009), New Jersey.
Chair: Pharmaceuticals Association OTC Regulations team (responsible for preparation of first guideline and
regulation for the OTC products and Borderline products) 1999-2001
Chair: Variation Regulations Team (amended the regulations according to the latest European Variation
Regulation), 1997-2001
Initiator: Pharmaceutical Association in order to adopt European regulations through newly formed committees. As an
active member of these committees, participated to the generation of Registration Regulation, Registration Guideline,
and Variation Regulation. 1993-2002
Committee member of Health Standards Preparation Committee of Turkish Standards Institute, 1987-1994
COMPUTER SKILLS
XHTML, HTML5, JavaScript, CSS, Information Visualization technics, Proficient in MS Office (Word, Excel, MS
Project, PowerPoint)
LANGUAGES
Fluent in English and Turkish
VOLUNTEER
School Library (2012-2014), Room Parent (2009-2012) , Chair Person for Art-Show (2010-2012), Representative for
Board of Education (2010-2012).

Kumru E. Kastro

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