Nikki Nogal, PhD
Senior CMC Consultant, Latham BioPharm Group
Dr. Nogal leads pharmaceutical Process Development at Lathambiopharm Group (LBG) helping clients generate, secure and execute on grants and contracts for the production of biopharmaceuticals (API, mAbs, vaccines, therapeutic proteins and enzymes). She is a biotechnology professional with more than twenty years in pre-discovery through lifecycle management of mature products, leading CMC projects that contrasted from “fast to market” or “quick to clinic”. She also supports the Strategic and Non-clinical Consulting sector offerings at LBG providing subject matter expertise and advisory services on pharmaceutical product development, strategic business development, and due diligence to clients.
In her most recent role as Head of Process Development at Abzena, she oversaw the process sciences and operations functions and led the implementation of new technologies to accelerate process development and enable robust process scale-up and tech transfer to manufacturing.
As a Senior Engineer at Genentech (Roche), she led process sciences operations to optimize commercial scale performance and global investigations for drug substance manufacturing, applying Quality by Design (QbD) concepts to process improvement, quality decisions, validation and audit risks. At Gilead, Dr. Nogal supported upstream process development for several late-stage clinical manufacturing campaigns of several high value new molecular entities. Her responsibilities also included internal/external technology transfer into GMP/commercial manufacturing for production of biotherapeutic proteins.
Dr. Nogal graduated with BS and MS degrees in Chemical Engineering from the University of Maryland and her PhD in Biomedical Engineering from Florida State University. She completed postdoctoral training at Johnson & Johnson Pharmaceutical R&D, and the University of California San Diego in Pharmacology and Bioengineering.