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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
   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.




2
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




  3

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Gary Steeves Resume

  • 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. 2
  • 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 3