1. GARY J. STEEVES
127 Jarrett Dr • Syracuse, NY 13219 • 315-256-7284
gsteeves@twcny.rr.com
PROFESSIONAL SUMMARY
Extensive experience collaborating with multidisciplinary groups including;
Manufacturing, Manufacturing Support, Quality Assurance, Quality Control, Regulatory
Affairs, and Validation.
Highly motivated with excellent problem solving skills and close attention to detail.
Work either independently or as a leader/member in cross functional teams.
Experience in process technical transfer, facilty fit, process implementation, process
monitoring/data management, and facility start-up and commissioning.
Experience providing technical expertise in Manufacturing unit operations including;
Inoculum, bioreactors, media/buffer batching and filtration, CIP/SIP, and primary
recovery.
Experince in regulatory documentation and inspection support.
PROFESSIONAL EXPERIENCE
2003 - Present Bristol-Myers Squibb Co. Syracuse, NY
Scientist, Process Transfer and Engineering 2005 - Present
Develop and maintain the central data file for all Third Party Manufacturing and Site
Manufacturing. Use the information to help identify improvements with yields, plant
efficiency and productivity through Statistical Process Control.
Established and Manage the Process Monitoring Group, using Aegis Discoverant
platform for data management. Experience in process hierarchy modeling, Paper Record
Input Manager (PRIMR), InVision tools and general maintenance of client application.
Work closely with the development staff to resolve process challenges.
Facilitate the transfer of upstream biologic processes to other internal and external
customers
Review exception documentation from Third Party Manufacturers
Manage weekly manufacturing performance meetings. Provide a vehicle for
communicating process related events across multiple sites and departments.
Provide technical support for Process Consistency/Validation campaigns
Provide technical support during campaigns for Third Party Manufacturers
2. Support regulatory filings for biologic processes and participate in regulatory agency
audits.
Scientist, Manufacturing Technical Services 2003 – 2005
Manage the authoring of new process SOP's/Batch Records and perform training on the
new changeover or batch clearance procedures.
Resolve process deviations as required.
Troubleshoot manufacturing process operability and equipment reliability and
reproducibility.
Prepare process improvement proposals for future changes and provide cost benefit
analysis.
1998 - 2003 Lonza Biologics Portsmouth, NH
Process Technologist 2001 – 2003
Develop and maintain the central data file on all manufacturing runs. Use the
information to help identify improvements with yields, plant efficiency and productivity.
Managed and supported customer collaboration meetings
Resolve process deviations as required.
Troubleshoot manufacturing process operability and equipment reliability and
reproducibility.
Process Operator III 1998 - 2001
Systems expert for Perfusion Cell Culture Process.
Schedule of daily activities.
Oversee activities (MBR review/initiate Deviation Reports/System Processing.
1996 - 1998 Unisyn Technologies Hopkinton, MA
Development Scientist
Liaison between Development Laboratory and Manufacturing.
Developed Hollow-fiber cell culture systems (CP100/CP1500)
Implemented Customer and Sales Training of new systems in Alpha/Beta Design stages.
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3. EDUCATION
1993 -1997 Univ. of Mass., Dartmouth Dartmouth, MA
B.S., Biology
2007 - 2010 Syracuse University Syracuse, NY
M.S., Chemical Engineering (exp. date of Grad Dec 2010)
SUPPLEMENTAL TRAINING
13th Annual Bioprocess Technology Seminars (September 25-29, 2000)
Bioprocess Equipment Design
14th Annual Bioprocess Technology Seminars (October 1-4, 2001)
CIP Technology
19th Annual Bioprocess Technology Seminars (October 23-27, 2006)
Bioprocess Purification Process Development
Discoverant System Administration Training (January 2008)
Advanced Certificate in Bioprocessing (Aug 2007 – June 2008)
Discoverant Basic Hierarchy Development Certification (October, 2009)
Global Leadership & Management Development (Development Dimensions
International 2010)
o Guiding Prinicples for Decision Making (2010)
o Manager Development Program (2010)
REFERENCES
References available upon request
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