PharmExcel Consulting helps manufacturers connect operational performance, facility readiness, and team development. The examples below describe work Rob Braddock performed during previous employment. They are career achievements, not PharmExcel client engagements. Employer and customer names are omitted.
Manufacturing performance · Facility readiness and reliability · Teams and operating systems
Manufacturing Performance
Rebuilding Customer Trust and Increasing Annual Output by 86%
At a manufacturer of GMP pharmaceutical and vaccine ingredients, Rob addressed staffing, process constraints, scheduling, and declining demand associated with unresolved GMP audit findings. He helped recover a key customer by addressing previous findings and hosting the customer onsite during production runs to rebuild confidence.
Rob added processing equipment redundancy to increase capacity and allow scheduled maintenance with less disruption. He reorganized shifts and added staff to move from 16 hours a day, five days a week, to continuous 24/7 operations. Together, these changes supported an 86% increase in annual production output over several years. This growth included added equipment capacity, staffing, and operating hours.
Reducing Annual Site Operating Expenses by 25%
At the same ingredient manufacturing site, Rob identified an opportunity to purchase a more concentrated intermediate and dilute it onsite. He evaluated the business case, negotiated supply terms, worked with Quality and technical teams to qualify the change, and led implementation. Lower raw material and transportation costs resulted in a 25% reduction in annual site operating expenses, based on full year spending before and after the change.
Using Manufacturing Data to Reduce Documentation Errors
At a cell therapy CDMO, Rob developed planning spreadsheets to coordinate client schedules, staffing, materials, and facility availability. He expanded the tools to track product yield, deviations per batch, errors relative to opportunities for error, and equipment utilization. Analysis highlighted process steps with elevated documentation error rates. The findings guided batch record revisions to clarify instructions, after which documentation error rates decreased.
Improving Production Readiness
Across cell therapy, pharmaceutical ingredient, and radiopharmaceutical operations, Rob used daily coordination meetings and detailed schedules to align cleaning, equipment setup, quality clearance, and production. He incorporated material kitting so materials were assembled and Quality approved before scheduled activities. These practices limited waiting and contributed to increased capacity. Their individual effects on changeover time were not separately measured.
Facility Readiness and Reliability
Reducing Operational Downtime by 25% at Each of Two Sites
Rob implemented predictive maintenance programs at a cell therapy startup facility and an ingredient manufacturing plant. Each site separately achieved a 25% reduction in operational downtime.
At the cell therapy facility, vibration analysis, thermal imaging, and transformer oil testing helped identify developing mechanical and electrical faults. At the ingredient plant, the program addressed reactor agitator motors, HVAC fan motors, electrical panels, rotary filters, and roof and distribution piping leaks.
Reducing Annual Site Utility Costs by 35%
At the ingredient manufacturing plant, Rob led assessment, equipment selection, and implementation of utility improvements. He resized air compressors, repaired distribution piping leaks, and resized water pumps to match production needs. Actual annual spending comparisons showed a 35% reduction in total site utility costs. This result was measured separately from the procurement initiative above; the percentages are not additive.
Planning Flexible Manufacturing Space
While leading a second site buildout for a cell therapy CDMO, Rob worked with his teams to accommodate future projects whose requirements were not fully defined. They mapped and risk assessed personnel and material flows, equipment placement, and production and support space. Reviews with other departments informed equipment relocations, revised entry routes, and added staging and support space.
Supporting Cell Therapy Regulatory Readiness
In an earlier Process and Facilities Engineer role at a separate cell therapy company, Rob supported BLA and preapproval inspection activities for a novel cell therapy product. He authored risk assessments and procedures for emergency power generation and continuous environmental monitoring systems, addressed maintenance and facilities gaps, supported qualification and validation, trained staff, and answered inspectors’ questions within his responsibilities. The program received FDA approval and progressed to commercial production.
Supporting Vaccine Scaleup and Inspection Readiness
Across process engineering, production supervision, and investigation roles, Rob generated data supporting vaccine commercial scaleup and FDA approval, supported preapproval inspection activities, and contributed to regulatory inspection readiness through production, maintenance, and facilities investigations.
Teams and Operating Systems
Building GMP Operations at a Cell Therapy CDMO
Rob joined an early stage cell therapy CDMO with one small facility, two production operators, one supply chain employee, limited procedures, and no established production planning. He built Manufacturing and Supply Chain, established the initial Facilities organization, developed foundational procedures for Facilities, Maintenance, Safety, and Operations, and contributed significantly to the initial quality systems.
He led a second site buildout and initially oversaw all GMP operations. As dedicated functions developed, his focus shifted to Manufacturing and Supply Chain. Both sites entered GMP production and supplied clinical trials. By his departure, the company had approximately 120 employees, including 30 in Manufacturing and Supply Chain.
Developing Manufacturing Leaders
Rob developed an organizational matrix based on projected needs across the CDMO’s two sites. Coaching, training plans, leadership assignments, and gradually expanded decision making authority prepared operators for advancement. Four operators became supervisors, and one subsequently advanced to Manager.
Preparing Two Sites for Client Audits and Clinical GMP Inspections
As Director of Manufacturing and Supply Chain, Rob led gap assessments, remediation planning, procedure and training readiness, and manufacturing and materials readiness across two CDMO sites, including a startup facility. These activities supported preparation for client audits and clinical GMP manufacturing inspections. Both sites subsequently manufactured clinical product.
Improving Purchasing Power
Rob drew on experience in larger organizations to restructure procurement at the growing cell therapy CDMO. Joining a purchasing consortium provided access to group purchasing arrangements and resulted in lower material prices and shorter lead times.
Discuss Your Manufacturing Priorities
Need to improve production performance, strengthen facility systems, or build an effective organization? Explore PharmExcel’s services or contact Rob to discuss your project.