Assistant Project

SUMMARY

Process Scientist/Chemical Engineer with extensive experience in culture of

mammalian, stem and bacterial cells and operation of small scale

bioreactors. Effective in bringing projects to completion, independently

and in team environments. Highly motivated to learn new procedures and

fundamentals. Areas of expertise include:

Upstream Process Development Ability to work well in a team

Fermentation environment as well independently

Perfusion and Fed-Batch bioreactor Ability to prioritize and execute

operation with attention to detail and

Stem cells/microcarriers precision

Aseptic Technique, GLP, GMP Document methods and procedures

Implement processes/ procedures Fluent in Spanish

Organization/Interpretation of

experimental data

PROFESSIONAL EXPERIENCE

Centocor R&D, Inc., Johnson & Johnson Pharmaceutical Research &

Development, LLC. 2003-Jan 2010

Associate Process Scientist (2008-Jan2010)

. Cell Therapy Group, Spring House, PA

. Established Technical Protocols for laboratory experimentation to

manage the implementation of the project.

. Led comparability study for stem cell project in small scale

bioreactor to generate data to be used as control for future

experiments.

. High success rate of maintenance and expansion of stem cells grown

on macrocarries. Performed preculture for all the small scale

bioreactor projects.

. Analyzed and presented experimental data and completed final

reports.

. Cell Culture Process Development, Radnor, PA (2008-2009)

. Led CO2 study and CEDEX evaluation study in 5L bioreactors, to

support Technical Transfer of cell culture process into Pilot Plant

at Cork.

. High success rate of maintenance and expansion of mammalian cells

using aseptic conditions and universal practices from thaw to 20 L

wave bag.

. Coordinated Safety activities for the department, leading to no

violations

. Maintained the Nova 100 instrument for a group of 20 scientists,

resulting in minimal downtime.

Associate Scientist I (2005-2007) Cell Culture Process Development,

Malvern, PA

. Led projects to qualify alternate raw material for cell culture

process in small scale bioreactors that reduced the risk of a single

source of raw material and potentially saved GBSC an excess of

$1,000,000 per year.

. Led media powder stability studies in small scale bioreactor for

different cell culture processes.

. Received Encore award in recognition of reduction of critical bovine

raw material risk.

. Led growth promotion assays for the evaluation of raw material

expose to temperature excursion.

. Led several successful trouble-shooting activities in improving the

performance of the Preculture train

. Earned several ENCORE recognition awards for excellence in small

scale bioreactors operation and Preculture.

. Replaced, after completing a performance evaluation, the NOVA 200

for the NOVA 400.

. Maintained the Nova 400 and BGA for bioreactor lab; no availability

issues when these instruments were required by costumers.

. Created the needed documentation (SOP's, Work Instructions),

bringing the Bioprocess Technology Department (BPT) lab towards

compliance solving a gap discovered during a mini BPT audit.

Assistant Scientist II (2003-2004) Cell Culture Process Development,

Malvern, PA

. Generated Preculture for inoculating of all reactors in small scale

bioreactor lab

. Designed and delivered training to maintain and expand mammalian

cells using aseptic techniques in T-flask, spinners and wave bags to

scientists for performing Preculture independently.

. Operated 5L perfusion bioreactors

. Achieved 0% of contamination in Preculture.

. Performed cell culture growth studies in T-flask,

. Sampling-CEDEX cell count, BGA for pH, pCO2, pO2 and NOVA for

metabolite analysis

. Operated AKTA for purification of harvest samples from bioreactor

lab.

Lehigh University-Bethlehem PA 1995-1998

Research Assistant (1997-1998), working for Professor Marvin Charles on

the project entitled "Viral Clearance Evaluation"

. Designed, executed and analyzed experimental data for the thermal

deactivation of E-coli bactheriophage.

. Trained a group of Lehigh students in preparation of virus stock and

quantification by means of plaque forming unit (PFU) method.

Research Assistant (1995-1998), working for Professor Janice Phillips and

BioProX, Inc. on the Ben Franklin project "Cell Line development for

Vitamin Intermediate":

. Maintenance of bacterial cell line in agar plate and shake flask

with high success rate

. Managed bioassay, colonies diagnostic and colonies isolation.

. Successfully ran fermentation from shake flask through 10L reactor.

EDUCATION

Bachelor of Science in Chemical Engineering, Universidad Tecnica Federico

Santa Maria, Chile SA.

Chemical Technology, (63 credits), Northampton Community College,

Bethlehem, PA, USA.

PROFESSIONAL TRAINING AND DEVELOPMENT

Cellular Bioprocess Technology, University of Minnesota.

Bioreactor Systems: Development, Design, and Operations, Society of

Bioprocessing Professionals.

Fundamentals of Biochemistry, The Center for Professional Innovation &

Education.

Protein Chromatography, The Center for Professional Innovation & Education.

Bioprocess Fermentation & Cell Culture Design & Scale Up, The American

Society of Mechanical Engineers.

Advanced Operator training of NOVA Bioprofile 400 Chemistry Analyzer.

AKTA System Design Training, Centocor.

JMP Software Training: ANOVA and Regression; Classic Design of Experiments.

http://www.linkeddin.com/in/anamiriamcataldo

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