Continuous Improvement Manager
I am an ASQ Certified Lean Six Sigma Black Belt (CSSBB) with a quality mindset. I employ 17+ years of training and experience in science (B.S., Chemistry), engineering (M.S., Chemical Engg.), law (J.D., licensed in Florida) and operational excellence (Lean Six Sigma) to optimize, harmonize and streamline business processes and procedures. I engage in manufacturing troubleshooting to identify the pain points, collect data, connect the dots, perform statistical and root cause analyses, isolate true root cause and suggest options that will lead to process robustness. I have completed multi-site projects.
The projects that I have completed have reduced complexity, increased customer satisfaction, lowered organizational costs, increased yields and reduced delivery (lead) times. I have coached lean six sigma practitioners and site leadership/senior management on lean 6σ principles and manufacturing excellence systems. I have also deployed site-wide lean 6σ manufacturing excellence systems. I have in-depth understanding and experience in the application of cGMP principles, standards, and best practices in the US and ROW. I have solid technical understanding of biologics and pharmaceutical drug substance/API manufacturing, sterile injectable manufacturing, fill finish (emulsion preparation, filling, Terminal Sterilization, visual inspection, packaging), risk management, non-conformance investigation using DMAIC principles, change control and CAPA management.
Wednesday, May 22
8:00 AM – 10:30 AM