Experience

Pacira BioSciences, Inc.

• United States
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Executive Director, Manufacturing

  • Apr 2023 - Present

  I provide overall management and leadership to the Manufacturing, Manufacturing Science & Technology (MS&T), EH&S, Engineering, and Maintenance organizations at the Science Center Campus (SCC). I develop strategic manufacturing plans for commercial and clinical manufacturing capabilities to ensure that product quality and capacity requirements are met. I manage the development and evaluation of the site's annual operating plan and capital budgets. I am responsible for ensuring EH&S… Show more I provide overall management and leadership to the Manufacturing, Manufacturing Science & Technology (MS&T), EH&S, Engineering, and Maintenance organizations at the Science Center Campus (SCC). I develop strategic manufacturing plans for commercial and clinical manufacturing capabilities to ensure that product quality and capacity requirements are met. I manage the development and evaluation of the site's annual operating plan and capital budgets. I am responsible for ensuring EH&S requirements are maintained in manufacturing areas and across the Science Center Campus. I participate with Process Development/ Research Teams to ensure new drug products can be commercially scaled-up and validated and meet regulatory operational requirements. Provide required functional resources to the teams as requested. Review and author the operations portions of the Manufacturing and Controls section of regulatory submissions for any commercial change requiring regulatory submission. This includes any new process that has completed technical transfer into commercial operations. Provide support as required to other Pacira locations in the areas of Manufacturing, MS&T, Engineering, & EHS.

• Director/Sr. Director, Manufacturing Science & Technology

  • Mar 2018 - Apr 2023

  I lead the daily technical support activities for manufacturing at the San Diego, Science Center Campus and support the on-site team at our CMO in Swindon, England. Monitoring data from commercial manufacturing operations to identify and resolve production issues, lead technical investigations, and design and implement process modifications to assure commercial supply and product quality. I provide leadership and management of the production of clinical liposomal formulations at Pacira… Show more I lead the daily technical support activities for manufacturing at the San Diego, Science Center Campus and support the on-site team at our CMO in Swindon, England. Monitoring data from commercial manufacturing operations to identify and resolve production issues, lead technical investigations, and design and implement process modifications to assure commercial supply and product quality. I provide leadership and management of the production of clinical liposomal formulations at Pacira in collaboration with Process Development. My team facilitates process transfers from PD to manufacturing. We author and provide support for the development of documentation (MBR, SOP, etc.) to support clinical and commercial manufacturing operations. I provide strategic planning input to the Vice President, Commercial Manufacturing for commercial and clinical manufacturing capabilities to ensure that product quality and capacity requirements are met. I am responsible for developing the MS&T annual operating plan and budget. I support Operational Excellence activities and the utilization of Lean/Six Sigma tools and best practices through training and implementation of process improvements. I act as a technical subject matter expert (SME) during Regulatory (FDA, EMA, MHRA, Anvisa) and Partner Audits.

• Associate Director

  • Apr 2015 - Mar 2018

  As part of the MS&T department I lead and/or participate on site and company-wide cross functional teams in high profile investigations and developmental problem solving of both EXPAREL and pipeline products. I am the interface between the Manufacturing and Development groups. The MS&T group leads efforts including the development of specialty studies, tech support, investigations and aseptic and process improvement in support of our current products. We also participate in the technology… Show more As part of the MS&T department I lead and/or participate on site and company-wide cross functional teams in high profile investigations and developmental problem solving of both EXPAREL and pipeline products. I am the interface between the Manufacturing and Development groups. The MS&T group leads efforts including the development of specialty studies, tech support, investigations and aseptic and process improvement in support of our current products. We also participate in the technology transfer of pipeline products both into SCC manufacturing suites and existing products out of the San Diego manufacturing site. As the owner of our development manufacturing suite I lead the manufacturing activities for clinical and developmental production in support of our pipeline development activities.



Hospira

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Group Leader

  • Oct 2013 - Apr 2015

  I lead a group of R&D scientists supporting analytical development, process development, and manufacturing support activities for third-party customers as part of the One2One® contract manufacturing organization. We led all technology transfer activities in support of product development, clinical manufacturing, and commercialization. The Lake Forest site supported all Hospira manufacturing facilities globally. As the R&D project leader for One2One® programs, I worked with the technical… Show more I lead a group of R&D scientists supporting analytical development, process development, and manufacturing support activities for third-party customers as part of the One2One® contract manufacturing organization. We led all technology transfer activities in support of product development, clinical manufacturing, and commercialization. The Lake Forest site supported all Hospira manufacturing facilities globally. As the R&D project leader for One2One® programs, I worked with the technical, program management, and business personnel from our customers with the goal of completing programs ahead of schedule and under budget. I collaborated with One2One® business development as the R&D subject matter expert and led the due diligence, scoping, and quotations of new programs and extensions to existing programs. I actively participated in dossier preparation and regulatory filings for third-party programs to the US and Rest of World submissions and managed the analytical and manufacturing regulatory requirements both in and outside of the US.

• Group Leader

  • Aug 2011 - Oct 2013

  I lead a group of R&D scientists supporting analytical development, process development, and manufacturing support activities for third-party customers as part of the One2One® contract manufacturing organization. We led all technology transfer activities in support of product development, clinical manufacturing, and commercialization. The Lake Forest site supported all Hospira manufacturing facilities globally. As the R&D project leader for One2One® programs, I worked with the technical… Show more I lead a group of R&D scientists supporting analytical development, process development, and manufacturing support activities for third-party customers as part of the One2One® contract manufacturing organization. We led all technology transfer activities in support of product development, clinical manufacturing, and commercialization. The Lake Forest site supported all Hospira manufacturing facilities globally. As the R&D project leader for One2One® programs, I worked with the technical, program management, and business personnel from our customers with the goal of completing programs ahead of schedule and under budget. I collaborated with One2One® business development as the R&D subject matter expert and participate in the due diligence, scoping, and quotations of new programs and extensions to existing programs. I actively participated in dossier preparation and regulatory filings for third-party programs to the US and Rest of World submissions and managed the analytical and manufacturing regulatory requirements both in and outside of the US.

• Supervisor / Group Leader

  • Jan 2010 - Aug 2011

  I lead a group of R&D scientists in analytical and process development and validation activities for One2One® programs through all technology transfer activities supporting product development, clinical and commercial manufacturing. As a member of the site Validation Review Board reviewed and approved changes at the McPherson manufacturing site that required R&D input and approval.

• Scientist

  • Nov 2007 - Jan 2010

  I was the R&D principal scientist on multiple One2One® programs. My responsibilities included analytical method development, technical transfers, analytical support of all R&D, clinical and process validation manufacturing batches. Noteworthy Highlight: Principal scientists involved in Hospira’s response to the global Heparin adulteration crisis.



Oklahoma City Community College

• United States
• Higher Education
• 400 - 500 Employee

• Adjunct Professor of Chemistry

  • Jan 2007 - Nov 2007

  Instructor in both classroom and laboratory sections of general chemistry. Instructor in both classroom and laboratory sections of general chemistry.



University of Oklahoma

• United States
• Higher Education
• 700 & Above Employee

• Postdoctoral Research Associate

  • Jul 2006 - Nov 2007

  Designed and performed crystallographic and biochemical studies of protein-protein interactions in yeast two-component signal transduction system. Determined crystal structure of synthetically activated, BeF3– bound SLN1-R1 in complex with YPD1. Designed and performed crystallographic and biochemical studies of protein-protein interactions in yeast two-component signal transduction system. Determined crystal structure of synthetically activated, BeF3– bound SLN1-R1 in complex with YPD1.