Senior Process Scientist Protein Purification

Carla Emolo, Ph.D.

Phone:+1-773-***-****; Email: **********@*****.***; https://www.linkedin.com/in/carla-emolo

Italian and US dual citizen

OBJECTIVE:

Enthusiastic and motivated scientist with strong background in protein science. Passionate about protein biochemistry applied to vaccine, therapeutic development, and diagnostic platforms. Constantly pursuing the translation of scientific discoveries into real world applications.

SUMMARY

Over ten years of experience in R&D, protein science, assay improvement, global analytical technical support, global process/product optimization and operations fields; acquired both in academia and industry environments (Abbott Laboratories, University of Chicago, Novartis Vaccine and Diagnostics)

Project management – Independently design, manage and conduct complex short and long duration projects with an extensive experience in recognize and resolve technical problem, identify alternatives plans and drive future directions.

Provide technical expertise to support commercial manufacturing of biologics linked to diagnostic business: trouble shooting and problem solving.

Recognizing opportunities and proposes novel ideas for significant operational, process or product optimization (yield, purity, stability).

Support R&D technology transfer from early discovery to operations.

Strong analytical skills with proven proficiency in planning, executing and or supporting experiments

Execute large molecule technical transfer processes, product and /or equipment characterization and validation from early discovery to operation matrix.

Extensive experience with Good Lab Practices regulations gained both in pharma and academia, understanding of GCP, GMP guidelines, FDA related environments, CAPA collaborations.

Support small scale and scale up trial activities.

Participation to risk assessment and submitting changes (i.e., pFMEA)

Solid organizational, verbal, and written communication skills demonstrated by successful track

records of ten peer-reviewed journal publications (plus one submitted for reviews), three patents

filings and several conference presentations.

Costumer first and business continuity attitude.

Excellent scientific leadership, supervising multiple research projects and training undergraduate

and graduate students.

Extensive experience in working with multidisciplinary and multinational teams.

RESEARCH AND WORK EXPERIENCE

Abbott Transfusion Medicine - Operations

Senior process scientist, Protein Purification Chicago, IL

Feb 2021-Present

Provide floor support to Manufacturing during real-time deviations and made risk-based decisions to prevent products impact.

Design and execute experiments to identify critical process parameters and planned and performed characterization studies.

Support R&D technology transfers into manufacturing operations, design verification and validation activities.

Identify actionable process improvements for yield and cost efficiency to align with strategic business priorities (i.e., SPC Statistical process control analysis)

Write scientific rationale to support Manufacturing and Quality Operations during investigations, Change Request (CR), Risk assessment (pFMEA), Design Plan, Quality Report (QR) and CAPA (Corrective Action Preventing Action) activities.

Abbott Diagnostics Division

Senior scientist, Global Technical support Chicago, IL

May 2020-Jan 2021

Support optimization and troubleshooting of diagnostic product performance.

Perform assay improvement studies on Architect and Alinity platforms.

Reformulate reagents to accommodate cost effective material, comply to EPA standards and/or more optimized product

Abbott Diagnostics Division

Senior scientist, Bioconjugation process characterization R&D Chicago, IL

June 2019- Feb 2020

Process optimization and characterization of bioconjugates to support diagnostic assay research and development.

Scale up of R&D bioconjugation processes to production scale to facilitate process transfer to the site of manufacture.

Applied several analytical techniques for characterization of proteins and bioconjugates.

Abbott Diagnostics Division

Senior Scientist, Global analytical technical support Chicago, IL

July 2018-May 2019

Responsible for the development, characterization, and validation of analytical test methods for Abbott high-value reagents (proteins, organics) and incoming materials (proteins, organics, detergents, commodities) like determination of Purity (SDS Page, Size exclusion and reverse phase HPLC, AccQ•Tag Amino Acid Analysis, acetate/citrate residual test) Identity (Dot/western blot).

Mycoplasma test method development to replace external to in-house alternative.

Provide technical services to the quality departments new methods, test method improvements, equipment upgrades.

Provide analytical chemistry support to assist in investigation closure and to resolve manufacturing issues.

University of Chicago, Department of Microbiology Chicago, IL

Scientist Associate, Schneewind Lab November 2015 – June 2018

Guided collaboration with Johnson & Johnson (Belgium) to identify the develop a promising S.aureus vaccine pipeline, engaging the main immunogenic coagulases domains and employing molecular, biochemistry and blood immunoassays.

Investigated the synergistic efficacy of monoclonal antibodies in ex vivo systems (primary human

blood products, cells) and in vivo murine models as therapeutics during S. aureus infections.

Developed a novel human whole blood assay, to examine how Staphylococcus aureus

manipulates host blood hemostasis to cause disease (OPK in whole blood).

University of Chicago, Department of Microbiology Chicago, IL

Post-doctoral fellow, Schneewind Lab December 2010 - October 2015

Utilized allelic recombination and complementation to engineer single and multi-gene knockout

strains to characterize staphylococcal agglutination and coagulation genes (coa and ClfA).

Generated mosaic antigens whereby the variable portions of Staphylococcus coagulases

proteins, from clinically relevant North American, Asian, and European isolates, were genetically

combined to obtain a universal vaccine.

Conducted in vitro and in vivo studies to evaluate the contribution of these novel vaccine

candidates, against S. aureus blood stream infections.

Generated murine monoclonal and recombinant antibodies against coagulation /agglutination

molecules, and employed molecular, biochemical approaches together with murine infection

model approaches to evaluate the protective efficacy of active and passive vaccination.

Columbia University, Department of Medicine New York, NY

Post-doctoral fellow, Harris P. Lab November 2009 – November 2010

Employed genetic, molecular, biochemical techniques to demonstrate the correlation between the

expression of pancreatic molecular transporter (VMAT2) and insulin, in human and mouse

pancreas tissues.

Novartis Vaccine & Diagnostics – Biochemistry Unit Siena, IT

Ph.D in Biology and physiopathology- Biochemistry unit September 2006 – October 2009

Biochemical characterization of RrgA as the major adhesin of S. Pneumoniae and as a

immunogenic against different strains in “in vivo” mouse model of infections protein along

with the mapping of two surface-exposed linear epitopes recognized by protective antisera.

High throughput platform purification and analysis of potential vaccine candidates.

National Research Center of Genetics and Biophysics Naples, IT

Fellowship September 2004 – September 2006

Established expertise in HPLC, FPLC, and mass spectrometry to biochemically characterize

proteins profiles in breast cancer.

High throughput platform for expression, purification and mass spectrometry analysis of potential

breast cancer biomarkers.

EDUCATION

University of Siena Siena, Italy

Ph.D. in Biology and Cellular Physiopathology – Biochemistry unit October – 2009

(Studies conducted in Novartis vaccine and diagnostics laboratories- Siena Italy)

University of Naples, Naples Italy

M.S. and B.S in Biology Science (summa cum laude) July - 2004

LABORATORY PROFICIENCY AND SKILLS

Biochemistry and Immunology: Recombinant protein expression and cell fractionation, purification by

FPLC, HPLC, Protein chromatography (ion-exchange, hydrophobicity, hydroxyapatite, affinity, size exclusion, reverse phase). Protein A, G and L antibody purification from non-mammalian, mammalian sera and cell culture supernatant, hybridoma cultures, SDS page, dot blot, slot blot, western blot, flow cytometry. Opsonophagocytic killing assay, ELISA Inhibition/competition binding assays.

Molecular Genetics: Nucleic acid extraction from bacterial and mammalian cells/tissue samples, recombinant DNA cloning, probe/primer design, bacterial allelic replacement and genetic complementation, transposon/chemical/site-directed mutagenesis, phage isolation and transduction, bacterial conjugation, Taq-man quantitative PCR, inverse PCR, cloning with recombinase technology (Gateway system), siRNA/DNA transfections, RNA extraction, RT-PCR, cDNA, sequencing and analysis of monoclonal CDR regions.

Cell Biology: culturing primary and immortalized cell lines, cell adhesion assay, transfection assay, scanning electron/confocal/immune-fluorescent microscopy.

Other:

Microsoft Office Suite, Adobe Suite, Image J, JMP, SAP system, Cognos IBM system, TrackWise, Bioinformatics analysis (NCBI, Finch TV, 4peaks, Chromas Genious), Empower, GraphPad Prism, Unicorn, Endnote, Imgt/v- quest for antibody sequencing.

Languages: Italian (native language) and English

PATENTS

Compositions and methods related to antibodies Staphylococcal Protein A, University of Chicago

PTC/US 9556281

Composition and methods related to antibodies that neutralize coagulase activity during

Staphylococcus aureus disease, University of Chicago PCT/US2013/031927.

Certificate in fundamental of Clinical research at University of Chicago.

SELECTED PUBLICATIONS

J. Bacteriology 2017 (with Sun Y, Holtfreter S, Schneewind O.et al)

J.Exp.Med. 2016 (with L. Thomer, T.V., S.O., Missiakas D.et al)

J.Biol.Chem. 2014 (with S. Becker, T.L, Q.A., S.O., Missiakas D. et al)

Vaccine 2014 (with HK., MD, and O. Schneewind)

J.Biol.Chem. 2013 (with K.HK, AC.D., Missiakas D. et al)

Infect. Immun. 2012 (with M.M, C.AG, Schneewind O. et al)

J.Biol.Chem 2011 (with G.MA., M.S., Masignani V. et al)

Infect. Immun 2010 (with M.M, B.M., Masignani V. et al)

Plos One 2010 (with S.G., K.E., Ferlenghi I. et al)

J.Bacteriology 2008 (with F.B., M.M., Barocchi MA et al

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