Doreen Ciolek

55 Washington Avenue ~ Whippany, New Jersey 07981 ~ (973) 590-0258 ~ dc7dc50a@we

stpost.net
ANALYTICAL CHEMIST ~ RESEARCH INVESTIGATOR ~ QC ANALYST ~ PRINCIPAL SCIENTIST
* Deep knowledge and experience developing and validating analytical methods for
drug substance/product release and stability, following strict GLP/GMP practice
s and guidelines.
* Lead Analyst responsible for performing trend analyses of stability data, deve
loping new procedures and processes for product release and stability and establ
ishing validation of protocols.
* Skilled communicator and vital team member, developing a variety of cutting ed
ge techniques, expanding areas of expertise and provide analytical support assis
ting in method development, impurity characterization, and releasing testing on
incoming discovery projects.
* Expert analytical writer with extensive hands-on experience preparing and revi
ewing analytical data for reports for FDA submission.
* HPLC Method Expert.
Core Competencies
* Method Development & Troubleshooting Specialist
* HPLC Expert for RP, IEC, & SEC
* Protein Determination including BCA Assay, A280, and TOC Analysis
* Cleaning Validation
* Product Release Testing, Method Validation and Transfer
* Calibration/Maintenance of Instruments/Equipment
* Analysis of Biotech Products including Pegylated Pharmaceuticals
* Protein Separation Techniques including Peptide Mapping, CZE, & SDS-PAGE
* Functional Knowledge of LIMS, Chemstation, Empower, & Microsoft
Professional Experience
ENZON PHARMACEUTICALS, INC RESEARCH ASSOCIATE III 2009 TO PRESENT
* Using analytical techniques and HPLC instrumentation, review and perform assay
s in support of in-process intermediates, drug product and stability sample test
ing for Enzon's marketed products; Adagen and Oncospar. Support process developm
ent and optimization using DOE technology to determine critical operation parame
ters and reasonable variation ranges for chromatography methods.
* Collaborate with various groups determining validity results of tests, trouble
shooting processes to establish protocols for current and future product testing
.
* Develop and implement protein separation methods to include: ion exchange, siz
e exclusion, reverse phase HPLC, and gel electrophoresis in determining purity,
impurity levels, content and degradation of pharmaceuticals, as well as interpre
t data, troubleshoot assays and instrumentation failures.
PD REGULATORY SERVICES, INC. INDEPENDENT CONTRACTOR 2006 TO 2008
* Prepared indexes and reviewed method and validation reports for CMC section of
NDA's and BLA's for FDA review.
HOFFMANN-LA ROCHE, INC. ASSOCIATE PRINCIPAL SCIENTIST 1990 to 2005
* Developed/executed analytical methods and formulations in order to identify ef
ficacious and stable delivery platforms of pharmaceuticals, specifically Roche's
recombinant protein therapeutic; Pegasys.
* Lead investigator of analytical deviations associated with drug product releas
e and stability to assure CFR part 11 compliance.
* Determine and performed appropriate analytical testing based on sample flow to
support clinical candidate selection.
* Utilized various data acquisition programs (AccessChrom, TurboChrom, Agilent C
hemstation), HPLC software, and laboratory information management systems.
* Coordinate results, writing analytical methods and specifications, validation
and toxicology reports for regulatory filling submission.
* Developed and validate analytical methods for various drug substance/drug prod
uct release and stability, following GLP/GMP practices.
.
Doreen Ciolek (973) 590-0258 ~ dc7dc50a@westpost.net Page Two
Education
M.S. BIOTECHNOLOGY, WILLIAM PATERSON UNIVERSITY, WAYNE, NJ
B.S. BIOLOGY, DOUGLAS COLLEGE, RUTGERS UNIVERSITY, NEW BRUNSWICK, NJ
Continuing Education
The Mechanics of Preparing INDs and NDAs and FDA Regulations, New Brunswick, NJ,
November 6-8, 2002
5th Symposium on the Interface of Regulatory and Analytical Sciences for Biotech
nology Health Products (WCBP 2001), Washington, DC, February 20-23, 2001
12th International Symposium on High Performance Capillary Electrophoresis and R
elated Microscale Techniques, Palm Springs, CA, January 23-28, 1999
213th American Chemical Society (ACS) National Meeting, San Francisco, Californi
a, April 13-17, 1997
10th International Conference on Methods in Protein Structure Analysis*, Snowbir
d, Utah, September 8-13, 1994
Joint presentation with Applied Biosystems (Division of Perkin Elmer) on "Using
C-terminal Sequencing for the Characterization of Recombinant Proteins"
7th Symposium of the Protein Society, San Diego, CA, July, 24-28, 1993
Professional Affiliations
American Chemical Society
Protein Society
Abstracts, Publications and Presentations
1. Michel H.P., DeBarbieri B., Ma Y., Ciolek D., Hollfelder K., and Pan Y.-C. E.
, July 1997. 11th Symposium of the Protein Society at Boston, Massachusetts, Cha
racterization of mPEG Modified Peptides with MALDI TOF Mass Spectrometry and Aut
omated N-terminalSequencing.
2. Ma Y., Michel H.P., Hollfelder K., DeBarbieri B., Ciolek D., Monkarsh S.P., S
pence C., and Pan Y.-C.E., August 1997. Annual Meeting of the American Society
for Biochemistry and Molecular Biology at San Francisco, California, The Determi
nation of Pegylation Sites in the Positional Isomers Isolated from a Monopegylat
ed Interferon alfa-2a.
3. Monkarsh S.P., Ma Y.M., Aglione A., Bailon P., Ciolek D., DeBarbieri B., Grav
es M.C., Hollfelder K., Michel H.P., Palleroni A., Porter J.E., Russoman E., Roy
S., and Pan Y.-C. E. (1997) Positional Isomers of Monopegylated Interferon *-2a
: Isolation Characterization, and Biological Activity. Anal. Biochem. 247, 434-
440.
4. Bozzini M., Zhao J., Yuan P., Ciolek D., Pan Y.-C.E., Marshak D., Horton J.,
and Boyd V.L. (1995) Applications Using the Alkylation Method for Carboxy-Termin
al Protein Sequencing, Techniques in Protein Chemistry Volume VI, edited by J. C
rebb.
5. Bozzini M., Ciolek D., DeBarbieri B., Hollfelder K., Boyd V.L., Yuan P.-Y., M
ichel H.P., and Pan Y.-C.E., July 1994. 8th Annual Protein Society Meeting at Sa
n Diego, California, Using an Automated C-terminal Sequencer in the Characteriza
tion of Recombinant Proteins.
6. Su C., Ciolek D., Zhang X.-L., Dharm L., Basu M., Nettleton M., Kochan J., Pa
n Y.-C. E. May 1994. American Society for Biochemistry & Molecular Biology Meet
ing at Washington, D.C., Characterization of the Interaction Between the Human I
gE-Fc and Fc*,RI* by Limited Proteolysis.
7. Dharmgrongartama E., Nettleton M., Hollfelder K., Waddington (Ciolek) D., Mic
hel H., Pan Y.-C. E., Crowther R., Graves B., Kochan J. Basu M., April 1994. Ex
perimental Biology '94 meeting at Anaheim, California, Purification and Characte
rization of Different Recombinant Forms of an IgE-Fc Fragment.
8. Ahmad Z., Ciolek D., Pan Y.-C. E., and Khan F.R. (1994) Purification and Char
acterization of a High Molecular Weight Form of Recombinant Human Interlukin-2.
J. Prot. Chem. 13, No 7, 591-598.
9. Su C., Wang F., Ciolek D., and Pan Y.-C. E. (1994) Electrophoresis of Protein
s and Protein-Protein Complexes on a Native Polyacrylamide Gel Using a Horizonta
l Gel Apparatus and Electroblotting. Anal. Biochem. 223, 93-98.
10. Wang F., Su C., Hollfelder K., Waddington (Ciolek) D., and Pan Y.-C. E. (199
3) Electroblotting Proteolytic Products from Native Gel for Direct N-Terminal Se
quence Analysis: An Approach for Studying Protein-Protein Interaction. Electrop
horesis 14, 847-851.