James Bunn

Experience

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  Medical University of South Carolina

  Mar 1998 - Mar 1999

  Research Assistant

  Rapidly derived expertise executing software programs in UNIX based systemsDeveloped strategic plan for extracting protein-docking sites using RASMOLSingularly conducted computer simulated experiments related to inverse protein dockingMeticulously interpreted technical data and results

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  Bard Davol

  Aug 1999 - Dec 2002

  Environmental Technician/Process Control Technician

  Monitored entire Foley catheter production line and LUBRI-SIL coating dip processContributed to the creation of a database for oversized productCreated concise spreadsheets allowing production summary and attendance tracking Assisted with the compounding of LUBRI-SIL catheter coatingUpdated departmental attendance recordsInvestigated root causes of thick funnel arms of cathetersCompleted daily In-Process-Quality-Assurance inspection checklistEmpirically tested production materialsMaintained chemical and latex dipping tanks according to specification Show less

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  Charles River Laboratories

  Dec 2002 - Oct 2023

  Developed and optimized formulations for various pharmaceutical and biotechnology products, ensuring product stability, quality, and regulatory compliance. Advised and consulted management and personnel. Transformed historical accuracy data within the Formulation department into actionable insights by migrating it into MS Power BI, facilitating data-driven decision-making. Demonstrated expertise as a subject matter authority, overseeing all facets of Formulation department operations to drive efficiency and excellence. Spearheaded product development studies in response to management directives, contributing to the successful creation of novel products. Facilitated the seamless transition of newly developed products from the Pilot Plant to general production, ensuring a smooth and efficient scaling process. Conducted thorough assessments and enhancements of departmental batch records and Standard Operating Procedures (SOPs), optimizing operational protocols thereby reducing product deviations by approximately 20%. Proactively executed Corrective and Preventative Actions to rectify issues and enhance departmental performance. Played a pivotal role as the Department Subject Matter Expert during the Electronic Batch Record project, actively participating in Siemens Opcenter Environment test script development and troubleshooting. Show less Provided strategic leadership and oversight for the Formulation department, ensuring the successful development, optimization, and transfer of pharmaceutical and biotechnology product formulations while maintaining rigorous quality standards and compliance. Applied Excel expertise to create programmable production calendar facilitating precise forecasting of inventory needs. Increased department productivity by approximately 30% while maintaining above 90% product accuracy. Consulted and advised Laboratory expansion. Sourced and procured new equipment. Provided direct daily supervision, scheduling, work prioritization, and reviewed the work of direct reports. Coordinated Limulus Amebocyte Lysate raw material appropriately according to production. Monitored in-process products for quality control, potency, and desired specifications. Oversaw process control activities to ensure compliance with FDA and SOP requirements. Assisted in the review, development, maintenance and communication of departmental systems and SOPs. Recommended short-range operating objectives such as organizational structure, staffing requirements. Ensured adherence to pertinent regulatory requirements, departmental policies, practices, and procedures. Oversaw execution of new formulations for production. Contributed successful solution to Root Cause Analysis Investigation of Limulus Amebocyte Lysate (LAL) product failures thereby reducing scrap in specific products by approximately 50%. Certified training in Quality Data Integrity policy. Directed annual project team of 20 temporary employees during seasonal lab operations for the purpose of harvesting vital company raw materials from Limulus Polyphemus (horseshoe crab) specimens. Show less Accurately formulated Limulus Amebocyte Lysate products to desired potency. Created concise spreadsheets allowing product potency and departmental performance tracking. Determined product potency via Kinetic Turbidimetric, Kinetic Chromogenic, and Gel-Clot assay. Executed protocol-specific procedures and experiments. Assessed data and advised empirical methods of detecting presence of impurities in production pump system. Researched literature, performed experiments, and implemented a new product to address LAL industry phenomenon “Low Endotoxin Recovery.” Sourced, procured, documented, and implemented, new reagent ultra-filtration system reducing impurities in reagents to nearly 0%. Show less

  • Formulation Specialist

    Dec 2020 - Oct 2023

  • Senior Supervisor, Formulations

    Jun 2015 - Dec 2021

  • Production Chemist

    Dec 2002 - Jun 2015
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  Boeing

  Jan 2024 - now

  Quality Systems Specialist