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

•

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.

•

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

•

fermentation tanks ranging in sizes from 40L to 20,000L

Performed Oxygen Uptake Rate & Carbon Dioxide Evolution rate studies

•

on Epothilone manufacturing process in 20,000L production bioreactor.

Team Leader for large scale fermentation manufacturing responsible for

•

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

•

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.

•

Wrote and executed IQ/OQ protocol for air monitoring test equipment.

•

Author of numerous SOP’s, MBR’s, Technical Reports and Validation

•

Protocols.

Consistently earns highest rating in manager’s reviews.

•

Contact this candidate