Safa Amiri

Background

About Safa Amiri

I currently head drug-product packaging and labeling initiatives at Novavax as part of the DP MS & T team, where I blend process engineering, applied statistics, and project leadership to keep life-saving vaccines moving safely and efficiently through global supply chains. My day-to-day spans: GMP vendor oversight & deviation management across a worldwide CMO/CDMO network—driving timely root-cause investigations, CAPAs, and change controls. Process validation & equipment qualification (IQ/OQ/PQ) for secondary packaging lines, shipping lanes, and device controls, ensuring every run stands up to FDA, EMA, TGA, and WHO scrutiny. Regulatory & quality documentation—authoring and reviewing SOPs, protocols, audit reports, and inspection-readiness packages that keep stakeholders aligned and auditors confident. Global artwork, labeling, and shipping strategies that balance compliance, cost, and speed so commercial and clinical product reaches patients on time and in spec. Highlights include building agitation, TOR, and cold-chain shipping protocols; leading cross-functional teams through critical quality events; and mentoring colleagues on statistics-driven process optimization—all while maintaining a laser focus on cGMP and supply-chain integrity. Prior to Novavax, I steered tech-transfer and pilot-scale projects in biopharma, desalination, and water treatment—earning recognitions such as the $50 K DOE Solar Desal Prize and three consecutive Top-16 Inventor nods for the Cade Prize in Florida. Outside the lab, I’m a multi-instrumentalist and founder of Safa Music Academy, where I help aspiring musicians find their voice—and their audience—through mentoring, curriculum design, and live performance opportunities. The creative problem-solving I practice on stage fuels the innovative thinking I bring to regulated manufacturing environments. Let’s connect if you’d like to trade ideas on drug-product manufacturing, tech transfer, packaging & labeling excellence—or even chat about violin technique. I’m always open to new collaborations and fresh perspectives.