DENISE HAGER

26 Kingswood Drive, North Stonington, Connecticut 06359

(860) 535.0698
(860) 235.5940
dhscrappinaway@yahoo.com

CAREER PROFILE
Creative, enthusiastic and highly skilled professional encompassing fifteen year
s of pharmaceutical and analytical chemistry experience. Able to multitask and h
andle diversified project load. Adept at working in cross-functional teams. Poss
esses strong analytical troubleshooting technical and project management skills
with innate ability in maintaining established relationships with all levels of
professionals. Quickly grasps challenging problems and provide creative solution
s. Proven track record of success in driving productivity as well as exceeding c
orporate standards and expectations by utilizing analytical, risk assessment and
problem resolution skills.
- Seeking a challenging career as a Clinical Study Manager, Supply Chain C
oordinator, Packaging Coordinator, QA and RegCMC to effectively utilize exceptio
nal work ethics, management skills and organizational leadership.
- Substantial experience in pharmaceutical industries as well as demonstra
ted expertise as an analytical chemist.
- Strong team player capable of working within the pharmaceutical arena an
d other various industries.

PROFESSIONAL EXPERIENCE

PFIZER ~ GROTON, CT
SENIOR SCIENTIST (COMPARATIVE AGENT DEVELOPMENT-PROJECT MANAGER) NOV 2005
-PRESENT
- Efficiently handle blinded comparative agent development (CAD) project w
orkload in support of the qualification, release and stability monitoring of bli
nded comparative agents.
- Identify and establish blinding options for comparative agents.
- Manage the development and validation of analytical methods through the
use of contract laboratory resources; utilize techniques, which include HPLC, UV
, FT-IR, Dissolution, Water, and various others.
- Perform the preparation of thorough documentation in line with cGMP conc
epts and Pfizer SOPs; efficiently write method development and validation protoc
ols, test procedures and LIMS product specifications
- Allocate expiry periods, storage conditions/restrictions, and pack codes
to the blinded comparative agents, subdivided commercial dosage forms and Pfize
r modified commercial dosage forms. Evaluate impact to the integrity of clinical
supply materials of temperature excursions during shipment or storage.
- Effectively define and instigate stability protocols as well as manage g
eneration and review of stability data and stability trends.
- Sustain accurate timing and cost projections for development projects as
well as identify and determine business and technical issues.
- Play a vital role in representing the department on global and cross-fun
ctional teams and initiatives.
- Constantly enhance compliance, efficiency and level of customer service
through providing input.
- Oversee adherence and effectiveness of contract laboratories through con
ducting annual technical audits as well as ensure comprehensiveness and accuracy
 of documents that pertain to comparative agents for regulatory filings.
- Proactively train and mentor four new CAD analysts.
SCIENTIST (ANALYTICAL RESEARCH AND DEVELOPMENT-PROJECT ANALYST) DEC 1997-NOV 200
5
- Functioned as a project laboratory analyst for various human health and
animal health products.
- Ensured the development and validation of various HPLC methods, such as
potency, chiral and achiral purity, cyclodextrin content, preservative content a
nd counterion assay.
- Wrote portions of the analytical sections of CTD for MAA and NDA filings
along with responses to regulatory queries.
- Conducted troubleshooting and resolution to challenges with methods and
formulations, such as identifying unknown impurities as well as isolating and id
entifying precipitates and particulates, leachable contamination, and others.
- Handled and performed stability programs to grant support in the develop
ment formulations as well as IND and NDA.
- Conducted IPC, release and stability testing as well as transferred anal
ytical methods through AMTE to other Pfizer sites as well as contract laboratori
es.

DUPONT MERCK RADIOPHARMACEUTICALS ~ NORTH BILLERICA, MA

STAFF SCIENTIST (CONTRACT POSITION) JUN 1997-DEC 1997 | JUN 1993-AUG 1993
- Efficiently developed and validated HPLC methods for starting materials
and intermediates of drug substance.
- Determined the purity and stability of the materials through conducting
quantitative and qualitative analyses.
- Wrote HPLC methods and validation reports; tested new methods to isolate
an impurity in a raw material used in the manufacture of a radiopharmaceutical.

BERTEK, INC. (DIVISION OF MYLAN PHARMACEUTICALS) ~ ST. ALBANS, VT

ASSOCIATE SCIENTIST DEC 1995-OCT 1996
- Functioned effectively in performing quality control tests to ensure the
stability, potency and purity of pharmaceutical raw materials, intermediates an
d finished product.
- Played an integral role in conducting dissolution of transdermal drugs a
long with the in-vitro testing for research and development using HPLC technique
s.
- Accurately wrote test documentation and the SOP in calibrating a dissolu
tion tester.

EDUCATION
Master of Science in Analytical Chemistry
University of Vermont, Burlington, VT ~ 1996
Bachelor of Science, Major in Chemistry | Minor in Mathematics
University of Rhode Island, Kingston, RI ~ 1993

PROFESSIONAL TRAINING
- Pfizer First Line: Leading Edge II
- Negotiating to Yes
- Performance Management
- Franklin Time Management
- Effective Oral Communication
- Continuous Improvement-Tools for Yellow Belt
- Creating a Culture of Inclusion
- Targeted Selection
- Advanced HPLC Method Development
- Enantiomeric Separations
- Practical Capillary Electrophoresis
- Sterile Pharmaceutical Dosage Forms: Basic Principals
- Particulate Trace Analysis Network Seminar
- Foreign Matter Inspection of Sterile Products
- Extractables and Leachables Forum
- Biopharmaceutics Training for Pharmaceutical Sciences
- Pharmaceutical Solids: Essential Knowledge and Advanced Concepts
- Site Quality Auditor Training
- Basic Statistics and Experimental Design
- Zymark TPWII
- Bacterial Endotoxin
- Microbial Limits, Bioburden, and Antimicrobial Effectiveness
- Sterility Testing

AWARDS AND HONORS

- Groton Friend of Education Award ~ for delivering faithful and conscient
ious service to the Groton public schools
- Pfizer Analytical Research and Development Impact Award ~ for conducting
investigation of the precipitate formed in low temperature Rimadyl injectable s
tability samples
- Pfizer Analytical Research and Development Impact Award ~ for providing
leadership role in the analytical transfer of the CJ-11,972 (drug substance, inj
ectable, and tablet) Project from Groton ARD to Sandwich ARD
- Pfizer Analytical Research and Development Impact Award ~ Ziprasidone Ca
psule – 100% Review of Stability Data for MAA/NDA Filing
- Pfizer Analytical Research and Development Impact Award ~ Chiral Core Te
am – for bringing the course Enantiomeric Separations to Pfizer ARD
- Pfizer SMART Volunteer Recognition Award ~ for outstanding commitment to
student interest in Math and Science
- Pfizer SMART Volunteer Recognition Award ~ for outstanding commitment to
teachers as a Middle School Liaison at Fitch Middle School
- Pfizer Individual Performance Award ~ for successful demonstration of ex
ceptional Pfizer values, leader behaviors, and performance in support to the fir
st extemporaneously prepared Comparative Agent Project
- Pfizer Individual Performance Award ~ for going above and beyond to supp
ort Pfizer’s community value through involvement with the SMART! Program in many cap
acities
- Pfizer Individual Performance Award ~ for going above and beyond expecte
d performance in the AC continuous improvement challenge
- Pfizer Individual Performance Award ~ for significantly reducing the SAM
JAM budget and delivering a quality product and rescheduling SAMJAM within four
weeks
- Pfizer Individual Performance Award ~ for exemplifying excellent teamwor
k and leadership for contributions to the GMP Analytics Group Launch Day

PUBLICATION
- Conducting Release and Stability Studies for Blinded Comparators, Primar
y Author: D. Hager; D. Healy, J. Kelly, A. Tolliver, Pharmaceutical Outsourcing
~ Sep-Oct 2010 (Pending Publication)

PRESENTATION
- Conducting Stability Studies for Blinded Comparators, D. Hager, CBI’s 3rd An
nual Conference on Comparator Studies March 2010 (Oral Presentation)

TECHNICAL SKILLS
Microsoft Word, Excel, PowerPoint and Outlook
GDMS ~ LIMS ~ Clinicopia ~ Symyx Notebook ~ TurboChrom ~ AccessChrom

ACTIVITIES
Pfizer SAMJAM (Science and Math Jamboree) Organizing Committee ~ 2005-Present
Pfizer SMART (Science and Math Are Really Terrific) Middle School Liaison ~ 2001
-Present