CAPRICE L.

HIGHTOWER
1344 South 33rd Street Home: (215) 336-2884
Philadelphia, PA 19146 ch10bf258@westpost.net Cell: (267) 231-7597

SUMMARY
Synthetic Chemist with 10 years of experiences in the pharmaceutical industry. R
eceived certificates in Regulatory Affairs and Bio-Organic Principles of Pharmac
eutical Sciences. Completed Master of Science (Chemistry) while working full tim
e. Proven expertise in both discovery and development processes. Experienced in
designing, conducting and interpretation of analytical studies for method devel
opment, stability testing and the validation of drug substances and drug product
s. Proven ability to take on new challenges and grasp new concepts in a fast pa
ced environment while effectively collaborating with team members to meet establ
ished goals. Possesses sufficient scientific knowledge to understand all aspects
of regulatory issues and ensure that appropriate, up-to-date records are mainta
ined for compliance. Compile data and documents into FDA acceptable formats. Exp
ertise includes solution and solid phase synthesis, purification, and characteri
zation of small drug molecules. Familiar with the drug approval process.

AREAS OF EXPERT
ISE

* Regulatory Affairs Certification

* Knowledge of FDA regulations and ICH guidelines
* Excellent time management skills
* Strong interpersonal/group skills
* Excellent computer & data mining skills
* Knowledge of the drug development process
* Ability to be flexible, creative, adaptable & efficient to see a project from
conception until completion
* Works collaboratively with colleagues at
all levels
* Excellent documentation, oral and written communication skills
* Thinks strategically
* Self-motivated
* Ability to manage, organize, prioritize, Effective problem solving and decisio
n making
* Experience working in GMP/GLP environments
* Presents data effectively at project and/or team meetings
* Excellent planning, organizational, and prioritizing skills
* Ability to critically evaluate and interpret scientific data
* Capable of multi-tasking
* Strong Research Skills
* Attention to detail and accuracy
* Knowledge of synthetic organic and analytical chemistry
* Broad knowledge and understanding of analytical methods, specifications and fo
rmulation development
* Able to manage multiple projects
* Knowledgeable in WORD and EXCEL
* Understands IND submission process
* Knowledge of chemistry that enables the evaluation of analytical records and d
ocuments that are intended for regulatory review
PROFESSIONAL EXPERIENCE
ASTRAZENECA PHARMACEUTICALS, Wilmington, DE 2001-Present
Scientist, Early Development (2008-Present)
Develop, validate and document analytical methods method in compliances with reg
ulatory authorities. Transfer analytical methods to support Safety Assessment a
nd Phase I clinical trials.
* Designed and conduct stability studies for drug substances and drug products t
o detect degradants and to establish a shelf-life.
* Worked with scientist in Discovery, Process R&D and Contract Research Organiza
tions to ensure quality and delivery of drugs.
* Conducted experiments to characterize and understand the physiochemical proper
ties of drug substances and formulations.
* Consistently ensured analytical testing is provided in a timely manner and wit
h quality to support project milestones.
* Expert utilization of synthetic chemistry to assist with identifying impuritie
s and potential degradations within drug substance and drug products.
* Developed a forced degradation protocols based upon global guidelines and Phys
ical Chemical Technical Report data to ensure that liquid chromatography techniq
ues can successfully detect and isolate a drug substance's parent peak from impu
rities or degradants.
* Performed appropriate solubility and stability studies to assist formulators i
n selecting the appropriate formulations in compliance to safety.
* Utilized analytical instrumentation including HPLC, UHPLC, UV-Vis, and 1H-NMR
to evaluate drug substances and drug products from discovery to Phase I clinical
trials.
* Working knowledge of Empowers, Chemstation, and Atlas
* Presented analyzed data during project meeting to update team members and cro
ss-functional teams on new developments.
* Participates in creating reports and updating management and team members on n
ew findings with Drug Substance/Drug Product
* Prepares the CMC section of an IND

Senior Associate Scientist, Medicinal Chemistry (2001-2008)

Developed synthetic routes for novel compounds for treatments of anxiety or schi
zophrenia. Identified opportunities to improve synthetic routes and to maximize
productivity through parallel synthesis and automated and microwave technologies
when applicable.
* Expertise in characterization and purification techniques (1H-NMR, 13C-NMR, MS
, HPLC, UV-Vis. Column Chromatography, automated Chromatography systems, vacuum
distillation and crystallizations) used to ensure the quality and integrity of
candidate drugs.

* Prepared milligram to multi-gram quantities of complex organic molecules for b

iological evaluation.
* Working knowledge of MS Word, MS Excel, ISIS base, Chemdraw, ISISdraw and Powe
rPoint to communicate new findings to cross-functional team members.
* Actively participated in recruiting highly motivated and competent synthetic c
hemist to fill departmental openings.
* Mentored a minority ACS scholar on the challenges and opportunities presented
to scientist working in the pharmaceutical industry.
* Participated in Electronic Laboratory Notebook Committee to determine the most
efficient technology to replace paper laboratory notebooks.
HOFFMAN-LAROCHE, Nutley, NJ 1999-2001
Associate Chemist, Medicinal Chemistry
Performed novel synthesis towards the development drugs for the treatment of met
abolic diseases.
* Utilized solid phase and multiple parallel techniques to maximize productivity
.
ZENECA PHARMACEUTICALS, Wilmington, DE 1999
Summer Intern, Medicinal Chemistry
Performed solution/solid phase synthesis, purification and characterization of n
ovel compounds.
TEMPLE UNIVERSITY SCHOOL OF PHARMACY, Philadelphia, PA 1995-1999
Medicinal Chemistry Trainee, Medicinal Chemistry (1998-1999)
Participated in a one-year industry sponsored training program to obtain practic
al laboratory experience in medicinal and organic chemistries.
Research Assistant, Inorganic Chemistry (1995-1996)
Studied the catalytic implications of the Keggin and Dawson ions.

EDUCATION
MS, Chemistry, Lehigh University, Bethlehem, PA
BA, Chemistry, Temple University, Philadelphia, PA
Undergraduate studies, Towson State University, Towson, MD

CERTIFICATIONS AND LICENSES

Regulatory Affairs in a Technical Environment
Bio-Organic Principles of Pharmaceutical Sciences

PROFESSIONAL ASSOCIATIONS
American Chemical Society, member
Chromatography Forum of Delaware Valley, member

PROFESSIONAL DEVELOPMENT
* Chromatography Forum of Delaware Valley Short Course: Introductory HPLC with h
ands-on training. West Chester University, West Chester, PA 2009
* Chromatography Forum of Delaware Valley Short Course: Introductory Gas Chromat
ography with hands-on training. West Chester University, West Chester, PA 2010
PUBLICATIONS
* Zhang, Min; Zhao, Chunlin; Hightower, Caprice L; Gabriel, Jerome L.; Canney, D
aniel J. Design Synthesis, and Preliminary Evaluation of 3-substituted Quinuclid
ines as Nictotinic Ligands. Book of Abstracts, 218th ACS National Meeting.
* Zhao, Chunlin; Zhang, Min; Hightower, Caprice L.; Gabriel, Jerome L.; Canney,
Daniel J. Divergent Synthetic Pathways to a Series of 2-substituted Quinuclidin
es: Potential Ligands for Nicotinic Acetylcholine Receptors. Book of Abstracts,
218th ACS National Meeting.
* Eddowes, Annette; Jansen, Susan; Hightower, Caprice L.; Buecheler, Nancy. Act
ivation of Oxidation Catalysts by Solvation. Materials Research Society, Decembe
r 1996.
* Smith, Zakiyyah; Jansen, Susan; Palmieri, Michael Jr., Murray, Frank; Hightowe
r, Caprice L.; Buechler, Nancy. How Does the Support Process Define Catalytic Ch
emistry of Dawson and Keggin Type Catalysts. Materials Research Society, Decemb
er 1996
* Draper, Jerome; Jansen, Susan; Moore, Richard; Hightower, Caprice L; Fenner, M
adeline; Wang, Shu- Hsien. Evaluation of Acidic and oxidation. Properties of Keg
gin Type Catalysts in Relation to Heterogeneous Catalysis. Materials Research So
ciety, November 1995.
* Jansen, Susan; Wang, Shu-Hsien; Lin, Chyanlong; Buecheler, Nancy; Fenner, Made
line; Hightower, Caprice L. Modulation of the Electronic states of Self-Assemble
d Metal Oxide Clusters in Sol Gel Matrices. Materials Research Society, November
1995.