Rozanne M.

Schondra
705 Mockingbird Lane,
Cuddebackville, New York 12729
Home phone: (845) 754-8599
E-Mail: rs10a0bbe@westpost.net
Job Objective
Seeking a position, that will focus either on chemical analysis, technical writi
ng or product stability which will offer challenge, growth and future. I have e
xperience with regulated environments where immediate requests and deadlines wer
e a part of my normal job. I have strong communication skills and found working
with different corporate sites enjoyable. In addition, I have authors many doc
uments for regulatory use. I have extensive experience as product stability man
ager for branded, generic and generic vendor products encompassing the initiatio
n of protocols to final reports. I bring broad experience and hands on knowledg
e to any position.
Professional Experience
Pfizer Pharmaceuticals (formally Wyeth Pharmaceuticals)
September/2001 to April/2010
Pfizer (formally Wyeth Research)
Pearl River, New York
Chemical and Pharmaceutical Development
Senior Research Scientist I
* Stability Chemist for new drug substances and drug products in development to
NDA submission and some marketed brand drug products.
* Facilitate the stability programs for formulationas new drug entities.
* Write new drug substance and drug product stability protocols for NDA submissi
ons and execute them.
* Set up accelerated, room temperature, bulk, light and shipping stability studi
es.
* Issued 51 stability reports for use in FDA and other Boards of Health filings
and 47(+) supportive stability reports required at time of Agency Inspection.
* Facilitate the daily sample distribution to laboratories.
* Update SOPas.
* Maintain GMP product inventories.
Wyeth-Ayerst Pharmaceuticals December/1991 to Septembe
r/2001
EsiLEDERLE
Pearl River, New York
Pharmaceutical Solids R. & D.,
Analytical Development Group
Stability Chemist
* Stability Chemist for pre-marketed generic drugs
* Wrote study protocols and executed them
* Set up accelerated and room temperature stability studies a" performed moistur
e and hardness studies.
* Evaluated data and recommended specifications for new products.
* Issued reports for FDA filings.
* Participated in MOCK-PAI activities, both as an auditor and the inspected.
* Managed controlled drugs a" provided inventories and ARCOS reports.
* Provided monthly schedules of products to be tested with requests for pending
data needed for ANDA and formulation reports.
* Updated and wrote SOPas for Stability Group.
* Worked in team atmosphere.
Lederle Laboratories, Inc. January/1984 to December/
1991
Pearl River, New York
Quality Control a" Marketed Product Stability
Stability Evaluator
* Stability Evaluator for marketed generic drugs from contract manufacturers and
in-house solid dosage forms.
* Review data packs from contract manufacturers for compliance before acceptance
as a Lederle product.
* Issue stability reports for in-house products for annual ANDA reporting.
* Perform yearly product compliance reporting.
Bio-Dynamics, Inc. 1983(Summer)
Millstone, New Jersey
Toxicology
Rodent Toxicology Technician
* Fed rats and mice and cleaned cages and rooms daily.
* Collected blood and urine samples.
* Examined rodents for any physical changes.
American Cyanamid Company September/1980 to October/198
2
Bound Brook, New Jersey
Research & Development, Chemicals Division
Analytical Chemist
* Analyze process developmentas and contract manufactureras organic samples by a
variety of methods, which included gas chromatography, High Pressure Liquid Chr
omatography, manual and automated titrations, spectroscopy and gravimetry with s
ome method improvement and development.
* Order chemicals and equipment a" affect a cost savings on solvents
* Participated in GLP committee a" evaluated sample traceability and recommend i
mprovements.
* Presented novel HPLC approach at American Cyanamidas 2nd Annual Analytical Con
ference.
Syracuse University September/1978 to September/1980
Syracuse, New York
Chemistry Department
Quantitative Analysis Teaching Assistant
* Instruct students in proper chemistry techniques and safety.
* Provide professor in charge with student evaluations.
Beech-Nut Foods Corporation June/1974 to June/1978
Canajoharie, New York
Analytical R. & D. Research Chemist
* Developed and improved chemical and microbiological analytical methods for the
analyses of micronutrients and toxicants by a variety of methods. Areas of foc
us were water-soluble vitamins, vitamin mixtures, mycotoxins, metals, anions, ca
tions and enzymes.
* Troubleshot production line problem in reference to copper in meat products.
* Researched juice products for their ascorbic and dehydroascorbic acid contents
.
* Researched color degradation in reference to metal interactions in fruit produ
cts.
* Trained and oversaw a technician.
* Ordered glassware, chemicals and equipment a" recommended books for library.
* Took part in collaborative studies.
Beech-Nut Corporation September/1973 to June/1974
Canajoharie, New York
Quality Control Technician
* Tested jar and cereal baby food product from the production lines.
a
Rozanne M. Schondra
705 Mockingbird Lane, Cuddebackville, New York 12729
Home phone: (845) 754-8599
E-Mail: rs10a0bbe@westpost.net

Education
Pharmacy Assistant Diploma
In-Progress Expected 03/2011
21 semester-hours in Biochemistry
Rutgers, State University
Piscataway, New Jersey
M.S. degree in Analytical Chemistry
Syracuse University
Syracuse, New York
B. S. degree in Chemistry
University of Albuquerque
Albuquerque, New Mexico