Robert Cool Email & Phone Number

• Advise project teams on the regulatory aspects of licensing new USDA regulated vaccine products.• Review and submit reports, protocols, and studies related to license applications and post-license support. • Create, update, and submit Outlines of Production for the control of licensed vaccine products. • Work as subject matter expert for the approval of internal change controls related to regulatory aspects of currently license processes. • Serve as Regulatory Affairs contact… Show more • Advise project teams on the regulatory aspects of licensing new USDA regulated vaccine products.• Review and submit reports, protocols, and studies related to license applications and post-license support. • Create, update, and submit Outlines of Production for the control of licensed vaccine products. • Work as subject matter expert for the approval of internal change controls related to regulatory aspects of currently license processes. • Serve as Regulatory Affairs contact for site process changes which impact products registered in Australia, New Zealand, and Japan.• Collaborate with scientists to gather information to gain successful applications for domestic and international shipping permits for experimental vaccines. Show less

St. Joseph, Missouri

Manage the transfer of pre-licenced veterinary vaccine products from R&D to production. These transfer projects require me to interface with nearly every department in the company to gather information, coordinate efforts and lead sub-teams. Responsible for post-research vaccine process development work in which I design, prepare, and execute experiments to optimize and scale numerous biological processes relevant to vaccine production.Extensive experience with bacterial, mammalian, and… Show more Manage the transfer of pre-licenced veterinary vaccine products from R&D to production. These transfer projects require me to interface with nearly every department in the company to gather information, coordinate efforts and lead sub-teams. Responsible for post-research vaccine process development work in which I design, prepare, and execute experiments to optimize and scale numerous biological processes relevant to vaccine production.Extensive experience with bacterial, mammalian, and insect cell cultures in volumes from lab-scale flasks and mini-bioreactor systems to industrial scale bioreactors. My department works to improve yields on licensed products and optimization of new products prior to submission to the regulatory agencies. I apply principles of DoE to characterize the design space of the processes and achieve timely results. This work requires scaling the biological processes up or down by applying numerous scale equations and characterizing the vessels needed. I summarize the work done in summary reports and present the relevant results and conclusions to management and other stake holders.Responsible for maintaining the laboratory building where my group is located by troubleshooting mechanical problems, submitting work orders, ordering supplies, etc. Show less