Jim Brown

About Jim Brown

I have spent my career designing new and modified equipment, processes, and facilities in the life science industries. I have also managed the execution of those projects to deliver the new technologies. Now, I help organizations through this process and create the alignment between their equipment and manufacturing capabilities and their business goals and go to market strategy. Some examples- Development of novel metal finishing equipment in the medical device industry- Tech transfer and integration of new equipment for biologics processing into a new facility- New equipment enabling process range expansions for spray dried dispersions in a pharmaceutical OSD- New technology development for lipid multiparticulate manufacturing in a pharmaceutical OSD.I use creativity and critical thinking, combined with my technical experience, to connect with teams and identify their needs and user requirements, create open dialogue to bring creative solutions to light, and deliver the project. I identify the technical solutions that align operations with the broader business goals so they can deliver.If you’re interested in discussing project-based or fractional technical leadership, I’d love to connect.

Experience

1. President Consulting Engineer

   Jim Brown Consulting Llc

   Oct 2023 — Present · Bend, OR, US

   I founded this consulting practice to guide organizations in the life sciences, manufacturing, and food and beverage industries through critical business transformations. My work has centered on elevating operational performance, driving execution on high-stakes initiatives, and embedding long-term solutions that endure beyond the engagement.Through the use of tailored consulting frameworks, designed to address strategic and operational issues, I am able to bridge the gap between operations, engineering & facilities, and project management to organize and streamline the execution of these initiatives. Communication, relationship building, and visual management techniques often uncover and allow resolution of challenges outside the scope of the original engagement.Partnered with a global pharmaceutical CDMO to build repeatable systems for asset management, reliability, and maintenance, improving compliance, visibility, and cross-team coordination.Brought in by a former employer to manage execution of a critical at-risk project to identify risks and issues, manage scope and contractual negotiations, and sustain project velocity during field installation, startup, and commissioning.Delivered advisory and execution support to cell and gene therapy client related to facility suitability and phase appropriate approaches to scale-up.

Education

• Montana Technological University

  BS - Engineering Science, Systems/Controls Option

• University of Memphis

  Graduate Certificate, Applied Lean Leadership - Herff College of Engineering

Skills

• Change Control
• Six Sigma
• Lean Manufacturing
• Computer System Validation
• Quality System
• Quality Assurance
• Process Simulation
• Engineering
• Standard Operating Procedure (Sop)
• R&D
• Pharmaceutical Industry
• Business Process Improvement
• Sop
• Fda
• Team Management
• Medical Devices
• Capa
• Gmp
• Project Management
• Biotechnology
• Process Engineering
• Ce Marking
• Research and Development (R&D)
• Continuous Improvement
• Iso 13485
• Process Improvement
• Validation
• Corrective and Preventive Action (Capa)
• Project Planning
• Technology Transfer
• Process Automation
• Process Control
• Control Systems Design
• Manufacturing
• Cross-Functional Team Leadership
• Software Documentation
• Program Management
• U.s. Food and Drug Administration (Fda)