Quality Control Development
Resume:
NEELIMA KOPPADA
**** ***** ******, # *** ? San Francisco ? CA 94109 ? 917-***-**** ?
**************@*****.***
EDUCATION
**/**** - **/**** *.Phil in Biomedical Sciences, Mount Sinai School of
Medicine, New York, NY
09/1999 - 06/2003 M.Chem in Chemistry (Awarded 1st Class Honors),
University of Manchester, UK
RESEARCH EXPERIENCE
08/2009 - Present Research Associate at Genentech, Inc., South San
Francisco CA
. Develop and qualify quantitative bioanalytical methods to characterize
antibody drug-conjugate biopharmaceuticals and their metabolites/
catabolites in the product development pipeline at Genentech.
. Develop LC-MS/MS methodologies to quantitate novel therapeutic
peptides and drug levels in biological matrices.
. Provide antibody-conjugation characterization support to Development
Sciences projects/ teams.
. Application of bioanalytical methods for routine analysis of samples
from pre-clinical studies.
. Provide mass spectrometry support and quality data to project and
filing teams to enable successful filing of all relevant INDs and
other key development activities.
. Provide mass spectrometry support and quality data to Early Stage
Research and Late Stage Research projects/ teams.
. Responsibilities include scheduling/ coordinating lab maintenance of
instruments with external engineers and training co-workers in
bioanalytical methods.
. Ensure the lab is Environment, Health and Safety (EHS) compliant.
. Present data as needed to cross-functional project teams and
departments.
. Member of the Core Planning Team for the 2013 departmental Offsite in
October
03/2008 - 08/2009 Research Assistant II at Regeneron Pharmaceuticals,
Inc., Tarrytown NY
. Biochemical characterization of therapeutic proteins in all stages of
development using analytical techniques: HPLC, UPLC, LC-MS, MALDI-TOF
MS, 1D IEF, SDS-PAGE and 2D gels and N-terminal sequencing.
. Characterize drug substance production and conformance lots for
sequence coverage, PTM analysis and disulphide bonds through peptide
mapping.
. Conduct in-gel digestion and subsequent LC/MS analysis for protein
identification.
. Developing a method of in-gel digestion by 1D IEF to investigate
antibody charge variants and investigate the source of charge variants
through peptide mapping.
. Responsibilities include scheduling and coordinating the group efforts
in the general lab maintenance and housekeeping.
07/2006 - 02/2008 Masters Student at Mount Sinai School of Medicine
Thesis Entitled: Identification of Novel Antimicrobial
Proteins in Cervical-Vaginal Fluid.
. Proteomic studies of Cervical-Vaginal fluid with iTRAQ labeling to
understand the antimicrobial activity, analysis using a Qq-TOF
instrument.
01/2004 - 04/2004 Analytical Chemist at Quality Control North West,
Stockport, UK
. Routine analysis of pharmaceutical products carried out by physical
and chemical testing such as HPLC analysis in a GLP environment.
08/2001 - 09/2002 Industrial Experience at GlaxoSmithKline, Stevenage,
UK
. Routine analysis of intermediates and final drug substances carried
out to determine purity using HPLC in a GLP environment.
. Developed a method to analyze Di-isopropylethylamine (DIPEA) using the
analytical techniques Ion Chromatography and Capillary
Electrophoresis.
TECHNICAL SKILLS
Mass Spectrometry
. Quantitative analysis of small molecules using a Triple Quadruple 3000
and QTraps 4000 and 5500 (AB Sciex).
. Proficient with the preparation, analysis and subsequent data analysis
of complex protein samples and protein digests using the QStar (AB
Sciex), LCQ, LTQ-Orbitrap (Thermo) and the Synapt HDMS (Waters).
. Trained in the usage and maintentance of the TripleTOF 5600.
. Analysis of intact proteins and glycopeptides by MALDI-TOF/MS Voyager-
DE STR (AB Sciex) and Axima CFR (Shimadzu) for biochemical
characterization.
. Analysis of intact proteins using the Qstar XL and Qstar Elite (AB
Sciex) for antibody-conjugation characterization.
. Protein identification by means of online peptide separation through
reverse-phase HPLC coupled to ESI-Ion Trap/MSn (Thermo) or ESI-
QqTOF/MSn, (Applied Biosystems or Waters) followed by database search
(Sonar, Pro QUANT, Mascot, Sequest or ProteinLynx Global Server).
. Experience with MassLynx, BiopharmaLynx, Xcalibur, Data Explorer and
Analyst.
Liquid Chromatography
. Qualified in micro-flow and nano-flow liquid chromatography
instrumentation including Shimadzu, Dionex, Agilent and Waters HPLC
systems.
. Method development of peptides and carbohydrates following subsequent
analysis using both HPLC and UPLC systems (Waters).
. Experience with Empower, Chemstation and Chromeleon software.
Biochemical and Biophysical analysis of proteins
. Characterization of proteins using 1D IEF, SDS-PAGE and 2D gels.
. In-gel digestions of SDS-PAGE and IEF gels for further analysis by
mass spectrometry.
. Routine analysis of proteins and peptides using N-terminal sequencing
(PROCISE Protein Sequence, Applied Biosystems) for support of various
groups in R&D.
. Protein quantitation using iTRAQ labeling technique (Applied
Biosystems) in proteomic studies.
. Protein identification and characterization using Western blots.
PUBLICATIONS AND PRESENTATIONS
Impact of drug conjugation on pharmacokinetics and tissue distribution of
anti-STEAP1 antibody-drug conjugates in rats. - Boswell CA, Mundo EE, Zhang
C, Bumbaca D, Valle NR, Kozak KR, Fourie A, Chuh J, Koppada N, Saad O, Gill
H, Shen BQ, Rubinfeld B, Tibbitts J, Kaur S, Theil FP, Fielder PJ, Khawli
LA, Lin K. - Bioconjug Chem. 2011 Oct 19;22(10):1994-2004. Epub 2011 Oct 3.
Poster Presentation: Matthew Hazen, Gail Shust, Emeralda Guzman, Neelima
Koppada, Rong Wang, Betsy Herold and Marla Keller. "Impact of the Menstrual
Cycle on Mucosal Immunity in the Female Genital Tract." (2007) Infectious
Diseases Society of America, San Diego, California.
GENENTECH AWARDS
2010 - Recognition Award (Extraordinary Productivity)
2010 - Key Development Sciences Award
2011 - Recognition Award (Outstanding Teamwork)
2012 - Key Contributor Award
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