Andy Ramelmeier

Background

About Andy Ramelmeier

An accomplished executive and technical leader with over 30 years experience and a strong foundation in development and manufacturing of biopharmaceuticals, including monoclonal antibodies, vaccines, gene therapy products, and therapeutic proteins. Contributed to the licensure of commercial products (VAQTA, Vimizim, Stelara, Simponi, Andexxa) in addition to process improvements for commercial products. Oversaw the design, construction and operation of 7 biologics production facilities, totaling over $500MM in investment. My focus and passion is clinical and commercial manufacturing. In my current role I have the privilege to not only manage the technical side of the business, I also help guide the company's growth while delivering the goods to our ultimate customer, the patients. Specialties: • Biologics manufacturing (bulk and fill finish), manufacturing site selection, commercial and clinical supply chain planning and strategy. • Strategic thinker and builder of organizations: strong track record in strategic planning, developing people, and collaborating across the company at the executive level. Strong financial accountability and experience creating and managing budgets and developing scenarios to reduce Cost of Goods (COGs) and improve Net Present Value (NPV). • Cost-effective, flexible and quality-centric manufacturing: proponent of lean manufacturing approaches, building quality into operations, and obtaining regulatory approvals. • Innovative facilities, engineering and IT experience: designing/building flexible, efficient factories using disposable technology. • Process development, tech transfer from R&D to manufacturing and tech support of marketed products. • Technical expertise spans fermentation, cell culture (perfusion and fed-batch), purification, formulation, and parenteral fill/finish. • Nationally and internationally recognized keynote speaker in the biopharmaceutical industry, guest lecturer at prestigious universities and scientific institutions.