NorthStar Medical Radioisotopes Adds Regulatory Affairs and Engineering Leaders to its Management Team
James Brodack and Rim Milunas Join NorthStar as it Advances Toward FDA Approval of its RadioGenix™ Isotope Separation System, Commercialization of New Molybdenum-99 Production Processes
BELOIT, Wis. (Sept. 12, 2016) – NorthStar Medical Radioisotopes LLC has hired James Brodack as vice president of regulatory affairs/quality assurance and Rim Milunas as vice president of engineering.
Brodack oversees day-to-day regulatory and quality operations at NorthStar. Milunas spearheads research and development. product design and engineering, with a strong focus on product development and production efficiency. The hiring of the two industry veterans comes as NorthStar advances toward U.S. Federal Drug Administration (FDA) approval of its RadioGenix™ intelligent isotope separation system and the commercialization of the two new processes it is developing for producing the medical radioisotope molybdenum-99 (Mo-99).
“Rim and James bring nearly 60 years of combined experience in research, product development, product management and regulatory affairs/quality assurance,” said NorthStar president and chief executive officer George P. Messina. “They have been senior leaders with some of the premier companies in our industry. They have long track records of successfully bringing complex new medical devices and pharmaceuticals to market. Those resumes make them ideal additions to our management team as we take the final steps toward becoming the first domestic supplier of Mo-99 since 1989.”
James Brodack – Vice President of Regulatory Affairs/Quality Assurance
Brodack has worked in the pharmaceutical industry for more than 26 years, holding multiple management positions with leading global companies. He comes to NorthStar from Guerbet, where he was director of regulatory affairs for the company’s Liebel-Flarsheim Company LLC business. Prior to that, he worked for Mallinckrodt Pharmaceuticals’ imaging business for 25 years, holding a series of increasingly responsible positions in both regulatory affairs and research and development. Before joining Mallinckrodt, he held several academic posts at Washington University in St. Louis, pursuing research interests involving positron-emitting radiopharmaceuticals and the use of robotics to automate radiopharmaceutical production.
Brodack has a doctorate in inorganic chemistry from the Massachusetts Institute of Technology and a Bachelor of Science degree in Chemistry from Eastern Illinois University.
Rim Milunas – Vice President of Engineering
Milunas has more than 30 years of engineering experience encompassing medical devices, mobile devices and automotive control systems, as well as extensive knowledge in hardware and software engineering.
Milunas comes to NorthStar from Baxter International Inc., where he was senior director, global product management for the company’s infusion systems business. Before that, he was director, program management – new product development for Baxter’s renal business. Prior to joining Baxter, he worked for Motorola Mobile Devices, Motorola Automotive and Industrial Electronics Group, Tenneco Corporation and General Motors Company’s Saturn Corporation subsidiary.
Milunas has a Master of Business Administration degree from the University of Michigan and a Bachelor of Science degree in mechanical engineering from the University of Illinois.
NorthStar Medical Radioisotopes LLC
Based in Beloit, Wisconsin, NorthStar Medical Radioisotopes LLC (northstarnm.com) was founded in 2006 to address the needs of the nuclear medicine market in the United States. A wholly owned subsidiary of NorthStar Medical Technologies LLC, the company is committed to resolving industry-wide supply challenges that have caused shortages of vital medical isotopes, negatively impacting patient care and stalling clinical research. Its patented technologies include innovative non-uranium based molybdenum-99 production methods, a novel separation chemistry system and tools for the nuclear medicine market.