Milena Opacic PhD Johnson&Johnson

I have extensive expertise in drug product development (Toxicology studies to commercial launch), with a primary focus on late-stage drug product development. My experience includes formulation, characterization, and process development for adenovirus, protein and bioconjugate-based vaccines, as well as oncolytic, lentiviral, and adeno associated virus–based therapies. I lead the authoring and reviewing of drug product development sections for the CMC dossier, specifically Module 3 (BLA, MAA). Prior to joining Johnson & Johnson, I worked at Baxter R&D Europe in Brussels, Belgium, where I contributed to late stage development and lifecycle management of advanced surgical products and renal solutions. I also completed two postdoctoral fellowships focused on stabilizing of membrane proteins using amphipathic polymers, known as amphipols, conducted in Amsterdam, The Netherlands, and Paris, France. I hold a PhD in Biophysical Chemistry from the University of Groningen, The Netherlands, and an MSc in Biophysics from the University of Belgrade, Serbia