Greater Birmingham, Alabama Area
With a BS in Chemical Engineering, I oversee a portfolio of ~ 40 GDP/GMP/cGMP life science and engineering O&M and capital projects and collaboratively lead cross-functional project teams, achieving innovative results! I'm best at impacting business operations through continuous improvement; formulating innovative, KPI/evidence-based production solutions; improving product quality; implementing risk management strategies; and optimizing processes. I also exhibit transferrable pharmaceutical product/process knowledge and customer service skills for excelling in pharmaceutical sales and effortlessly adapting to changing situations, understanding client needs, and resolving underlying technical, project management, process, and people issues. SKILLS • Project Management • Process Improvement & Optimization • Cross-Functional Communication • Continuous Improvement • Root Cause Analysis, Troubleshooting • Procurement • Quality Management • Risk Management • Compliance (GDP/GMP/cGMP) • Corrective & Preventative Action • Policy & Procedure Review • OSHA Compliance • Data Analysis, Accuracy • Data Management • MATLAB, Aspen Plus • QMS, Master Control • Microsoft Office/Excel Power User • Google Suite
(Avanti is part of Croda International PLC) | Oversee process improvement and capital projects at Avanti, a research and pharmaceutical development, kg-scale batch manufacturing pilot plant for GMP-quality lipids, APIs, adjuvants, and raw materials (LNP technology for COVID-19 vaccines). Committees: Process Improvement, Health and Safety, North American Diversity Equity & Inclusion, and Production-Quality. • Impacted lab safety by recommending a mechanical solution for heat exchangers/circulators to prevent flooding. • Prevented batch overflows by implementing punctuated charges to give batch pressure vessel time to recuperate. • Recommended upgrading outdated batch glass reactors to safer, cost-effective, and environment-friendly designs. • Demonstrate advanced project management acumen by coordinating all project phases from initiation to manufacturing. Build project teams. Provide detailed planning, product specifications, materials, and documentation. • Use Quality Management Systems (QMS) and effectively communicate with cross-functional personnel. • Use KPIs to track objectives and progress. Provide technical and process support to optimize performance. • Ensure and document compliance with cGMP, GDP, and OSHA for an annual portfolio of 40 varied in-process batches. • Understand cGMP complexities and liabilities of maintaining compliance in manufacturing settings. • Initiate and drive manufacturing investigations and suggest corrective and preventative actions; engage and solicit input from Subject Matter Experts and Quality Managers. • Help overhaul training protocols and establish professional development pathways (integration to Croda’s standards). • Design and implement production procedures for contaminates found during processing. • Help validate and qualify new GMP equipment. Apply OSHA standards.
Biosystems Engineering, under Dr. Sushil Adhikari | Performed biomass gasification and undergraduate research for Electrical Power Research Institute (EPRI). • Operated multiple batch reactions for doctorial research. • Conducted tests of different biomass sample groups to extract biofuel and char samples. • Performed multiple ash analysis to determine what compounds were present after heating