Rob Carpenter

About Rob Carpenter

I am an Operations and Engineering leader with 25 plus years of experience working in small molecule, monoclonal antibodies, vaccines, plasma, gene therapy and biotechnology industries in bulk drug substance, drug product and fill finish. I have worked for multiple leaders in the pharmaceutical and biotechnology industries in the areas of Research and development, Process development and characterization, commercial operations technical support and management, product site to site transfer, facility start up, and also facility design with a focus on capital equipment. I am a very focused and results oriented team leader with demonstrated success in leading and developing cross functional technical teams, project management, and process and system design. Areas of expertise: Capital Project Planning & Management, Facility Design, Operation and Start-up, CMC Operations, Budget Analysis, Financial Management, Project Management, Lean Six Sigma Certified Engineer, Scientific Mentorship and Guidance

Experience

1. Executive Consultant

   MMR CONSULTING

   Jul 2024 — Present · CA, US

   Offering consulting services to the medical device, pharmaceutical and biotech industries, to enquire about potential request for proposals or support please contact directly or message through LinkedIN. Primary offerings:CMC Life Cycle Development DS & DP-Process characterization, Technical Documentation development for regulatory filings. DS & DP process scale up, design, technology selection, and transfer & site selection to CDMO, CMO or Internal Sites and Production oversightFacility Fit Assessments: PAI, Process Capabilities, Compliance Gaps, Facility Capacity and transfer costing OPEx and CAPExCAPEx Program & Project Delivery- Turn Key or Staff Support, PM & EngineeringCQV - DS, DP Process Equipment, Clean Utilities & Central UtilitiesPreventative Maintenance, Predictive Maintenance and Reliability Engineering Support

Education

• Rose-Hulman Institute of Technology

  B.S, Chemical Engineering

  1994 — 1999

Skills

• Process Improvement
• Gmp
• U.s. Food and Drug Administration (Fda)
• Manufacturing
• Capa
• Change Control
• Technology Transfer
• Pharmaceutical Industry
• Fda
• Validation
• Quality Assurance
• Engineering
• Quality System
• V&V
• Process Simulation
• Biotechnology
• Process Engineering