Thank you for your interest in NorthStar!
NorthStar Medical Radioisotopes, a subsidiary of NorthStar Medical Technologies, was founded to address the needs of the nuclear medicine market. We are currently based in Madison, WI and are expecting to build a facility in Beloit, WI.
Please feel free to look at our career opportunities below. If you are interested in applying for an open position, please forward your resume to firstname.lastname@example.org with the position title in the subject line. Please no phone calls.
This position is responsible for establishing production processes to ensure the final product meets or exceeds its specifications. This position plays a crucial role in the organization, liaising across various business professionals to deliver designs equipped for manufacture and providing solutions to the problems concerning the design and manufacturing processes. This position is responsible for delivering quality engineering production solutions in learned response to development, hardware, manufacturing, and operational needs. We are seeking candidates with a Bachelor’s degree in Electronic, Mechanical, Industrial, or Electrical engineering and 2-4 years of experience in the field or in a related area. Knowledge of linear accelerator technology, chromatography, or radiation experience is a plus.
Regulatory Affairs Manager
This position will have primary responsibility to compile and file DMF/ANDA/NDAs and acquire the appropriate marketing approvals while ensuring compliance with applicable FDA regulations. Secondary responsibilities will be to obtain appropriate international registration with appropriate competent authorities as required by company strategic planning. The function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable radiopharmaceutical products that are developed, manufactured or distributed to meet required legislation. The individual has department level influence and is recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.
We are seeking candidates with a Bachelor’s degree in pharmacy, biology, chemistry or engineering and more than 8 years of experience in the pharmaceutical industry with a minimum of 5 years in regulatory affairs or quality assurance. Experience with eCTD submission is required and radiopharmaceutical experience is preferred.
A successful candidate requires a Bachelor of Science degree and 10 years of product development experience with programming of Windows™ operating system host computers that interface or control real-time processing equipment. The candidate must have demonstrable experience with using Windows GUI environments including the .NET development software. Software development must adhere to cGMP guidelines for medical devices or pharmaceutical processing. The candidate must have excellent problem solving skills and effectively communicate in a cross-functional team environment and with management. An effective candidate must be able to work well under pressure, complete tasks in an organized manner and with a high degree of accuracy.
The candidate must possess a BS in analytical chemistry or chemical engineering and 5 years work experience explicitly demonstrating familiarity with pharmaceutical or cGMP production regulations. The successful candidate will have intimate knowledge of production batch records, work environment safety and understanding of quality system compliance. The candidate must be organized and have good documentation skills. The candidate must be reliable, able to effectively prioritize their work, work well with deadlines, communicate with peers and management and meet production goals.
The candidate must possess a BS in chemistry or radiochemistry with at least 5 years of experience with handling and analyzing samples. Familiarity with instrumentation including ICP, LC, LSC, HPGe and wet chemistry methods is needed. The candidate will be performing a wide variety research and development tasks using wet chemistry and open sources of radioactivity. Must be able to demonstrate familiarity with modern nuclear measurement techniques, instrumentation and software.Being well organized with good documentation skills is required and the ability to effectively communicate to peers and management is necessary. The candidate must be reliable, accurate, work well under supervision, able to effectively prioritize their work, work well with deadlines, and complete assignments in a timely manner.