1. David Sitty
319 Laura St, Salina, KS 67401 | (785) 914-8496 | davidsitty@gmail.com
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Summary: Dedicated team contributor with a strong background in downstream operations in
the Pharmaceutical/Biotechnology industry. Extensive work experience in manufacturing,
documentations, and production development. Detailed oriented with the ability to deliver high
quality results within set timelines. Passionate about process optimization and operational
excellence.
Education: California State University Sacramento, Sacramento, California
Bachelors of Arts in Chemistry (with an emphasis in Biochemistry) Jan 2010
Qualifications:
Worked in a cGMP facility
Writing, editing, modifying SOP’s
Process and production development
Troubleshooting process equipment, calibrations, and PM’s
Experience with bacterial fermentation, diafiltration, process handling, CIP, SIP, buffer
makeups, waste handling, sterile environments
Process improvements and optimizations, P & ID’s
HPLC’s: Worked with Unicorn, ATKA Prime Lab scale, 10mm Amersham
Vialing Experience in pilot scale: Collozzi semi-automated vialing and capping
machines
QC duties: Bradford assay, ELISA, endotoxin assays, kinetics assays
Involved in Audits (non-internal)
Work Experience:
DesigneRx Pharamceuticals, Vacaville, CA
Assistant Engineer (Feb 2015 – Apr 2015):
Worked with new processing equipment with respect to its production step. Developed
new SOP’s based on P&IDs and research for potential equipment.
Assist in purchasing a new vialing equipment and the future construction of a cGMP
vialing production floor.
2. Production Manager (Jan 2014 – Apr 2014):
Managed SOP’s and deviation reports, trained employees, involved in FATs and SATs.
Senior Production Scientist (Apr 2012 – Jan 2014):
Overlooked and also involved in downstream production with responsibility to process
equipment, product deadlines, deviations, inventory management for reagents and
process restocking/orderings and reported to the company’s Director.
Worked with production team to optimize ADI refolding.
Assistant/Associate Production Scientist (Apr 2011 – Apr 2012):
Worked with a production team to produce ADI-PEG 20 by using a series of
chromatography columns and buffers.
Refined ADI-PEG 20 by using a GE Kvick Crossflow diafiltration system.
Vial the ADI-PEG 20 by using a Cozzoli vialing machine.
Genentech, Vacaville, CA
Bioprocessing Technician (Mar 2010 – Apr 2011):
A member of Genentech’s Purification Operations Group (POG) working downstream of
the manufacturing process to purify and obtain proteins using a series of HPLCs.
Duties in POG include large scale buffer make-ups, run/monitor automated recipes with
respect to the production process, and to assist in deviations.