Ray S. Randall
** ****** ***** *************, ** 13027 315-***-**** abhfdv@r.postjobfree.com
RESULTS-PROVEN ENGINEER/Scientist
Currently Specializing in Cell Culture
Experienced Cell Culture/Fermentation Specialist with a 7-year record of success in process and equipment
improvements.
Experienced with Bacterial and Mammalian Upstream Process Development and Support within cGMP Environment
M.S. Bioprocess Engineering, SUNY ESF, Syracuse, NY - 2008
Education
Major Professors: Tom Amidon, Ph.D., Tom Keenan, Ph.D.
Research Topic: Optimization of Polyhydroxyalkanoate
Production utilizing Xylose
Project Management – Project Management Professional (PMP)Coursework
- 2010
Human Error Investigation Certified – Talsico International – 2010
Lean Six-Sigma Yellow Belt Certified - 2010
Graduate Certificate, Bioprocess Engineering, SUNY ESF, Syracuse, NY -
2005
B.S. Photonics/Engineering Technology, SUNY Institute of Technology,
Utica, Rome – Graduated Cum Laude – 1991
Training Certificate – Steam Systems, Armstrong Intl Steam University –
1996
Training Certificate – Cooling Tower Applications, Clearwater Corp - 1996
Professional/Technical Skills
• Quality event investigations using Human Error Diagnostics
• Author of
o Manufacturing campaign summary reports
o MBR’s
o SOP’s
o Facility Fit Reports
o Technical Memo’s
o Change Controls
• Statistical experimental design techniques and optimization, proficient in
Statease & JMP statistical software.
• New Equipment Start Up and Validation (IQ/OQ/PQ)
• Thorough knowledge and troubleshooting of lab-scale (7-14L) through large-
scale bioreactors (100,000L).
• Core Team member for several biologic process transfer teams.
• SIP and CIP cycle development.
• cGMP compliance and documentation, validation (IQ/OQ/PQ) of process
equipment and cleaning validation.
• Proficient in using advanced automation software; Delta-V & HMI interfaces
for fermentation equipment from lab scale to industrial scale,
• Excellent analytical and trouble shooting skills.
• Recognized for attention to detail and commitment to deadlines.
Ray S. Randall
25 Athena Drive Baldwinsville, NY 13027 315-***-**** abhfdv@r.postjobfree.com
Career History
Bristol Myers Squibb, Syracuse, NY (2003 – Present)
Engineer – Manufacturing Support (March 2010 – Present)
Scientist –Manufacturing Sciences (Jan 2009 – March 2010)
Manufacturing Team Lead (Oct 2008– Jan 2009)
Senior Process Operator (Sep 2005-Oct 2008)
Process Operator (Apr 2003 - Sep 2005)
Quality event investigations and reports including root cause analysis and
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CAPA (correction and preventative action)
Characterization studies for an engineered fusion protein produced by
•
Chinese Hamster Ovarian (CHO) cells, utilizing DOE designed
experiments
Change control author and corresponding project management.
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Interaction with numerous onsite management and quality groups driving
completion of projects.
Team member of (Research and Development) Group designing,
•
implementing and analyzing 14L fermentation process optimization
studies for secondary metabolite protein production from gram negative
mycobacterium.
Performed engineering studies on oxygen transfer capabilities of
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fermentation tanks ranging in sizes from 40L to 20,000L
Performed Oxygen Uptake Rate & Carbon Dioxide Evolution rate studies
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on Epothilone manufacturing process in 20,000L production bioreactor.
Team Leader for large scale fermentation manufacturing responsible for
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scheduling, cGMP compliance, FDA regulations, equipment
troubleshooting, & supervision of all on floor operations including
personnel training.
Delta V control system upgrade implementation team lead for Bldg 75
•
Upstream Operations.
Team Lead for Escherichia coli fermentations for the production of
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engineered proteins.
Numerous troubleshooting team memberships including contamination
•
investigations, equipment modifications, and automation upgrades.
Wrote and executed IQ/OQ protocol for filter integrity test equipment.
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Wrote and executed IQ/OQ protocol for air monitoring test equipment.
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Author of numerous SOP’s, MBR’s, Technical Reports and Validation
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Protocols.
Consistently earns highest rating in manager’s reviews.
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