The Finance Intern will work with team members to assist in day-to-day financial activities and complete special projects in support of NorthStar’s financial goals and strategies. 

The Quality Assurance (QA) Specialist is responsible for providing QA input and guidance for Manufacturing, Supply Chain, Quality, and R&D activities. The QA Specialist will perform all responsibilities in accordance with company policies, procedures, global regulations and safety requirements.   This position supports production in a 24-hour manufacturing facility which means your schedule provides days off during the week when weekend work is required.  Early morning, weekend, and some holiday work will be required.

The Senior Health Physicist (SHP) promotes NorthStar’s culture of safety by advancing radiation, health, and safety programs that embody a healthy working environment and compliance with regulations established by Wisconsin for radioactive material and electron accelerators, OSHA, DOT/IATA, EPA, NRC, and Agreement States.  The SHP assists the Senior Manager, EHS, RSO with identifying, evaluating, managing and preventing hazards in challenging research, manufacturing, and production workplaces.

The Nuclear Engineer II/Senior Nuclear Engineer will contribute to advancing cutting-edge particle accelerator-based radioisotope production and processing systems. This role will collaborate closely with engineers and physicists across various stages of system development, encompassing specification, development, implementation, qualification, and commissioning of isotope-producing and processing systems. Additionally, the Nuclear Engineer II/Senior Nuclear Engineer will engage in detailed analysis and modeling of the system, addressing key factors such as dose, heating deposition, activation, and isotope production. This role will possess a solid grasp of the fundamental principles and physics behind particle accelerators, with specific emphasis on electron accelerators, or other radiation-producing devices, including nuclear reactors. As part of the nuclear engineering and physics team, this role is pivotal in driving our ongoing, interdisciplinary projects forward. The Senior Nuclear Engineer will not only contribute significantly to ongoing interdisciplinary projects, but also take the lead in spearheading and developing initiatives across cross-functional teams. The Senior Nuclear Engineer's expertise will be instrumental as an integral role in shaping the design and development of our innovative, cross-functional endeavors.

The MS&T Engineer II is responsible for supporting both internal and external manufacturing and technical transfer activities to support manufacturing readiness. This includes developing and executing operations and maintenance procedures and other necessary documentation to ensure effective process transfer between process development and operations.   The MS&T Engineer II is responsible for developing and evaluating manufacturing processes and implementing equipment and tools for production. This position will lead the coordination of product and process improvements to meet quality and production goals.   The MS&T Engineer II is a key role in relation to system management and performance ensuring that operating, maintenance strategies are optimized through sound decision making and planning, and continuously improved through feedback of operating experience and data.   The MS&T Engineer II will gain an appropriate level of expertise in relation to allocated systems and equipment with an overall understanding of the drivers and limitations of system reliability and the ability to provide sound technical support, advice, and training to operations and maintenance functions.   All duties and responsibilities will be done in compliance with applicable regulatory agency standards.

The Supplier Quality Engineer/Senior Supplier Quality Engineer will contribute to the improvement of existing supplier quality assurance processes interfacing with suppliers, internal supply chain team, QC team, manufacturing, and engineering groups to resolve problems encountered in the supply chain. Assess the capability and capacity of suppliers to perform current or potential future services. Develop training materials, performance metrics, and other resources to support improvements in supplier performance and productivity. Projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agency standards.  

The Analytical Chemist I/II is responsible for the preparation and analysis of radioactive and non-radioactive samples generated in NorthStar’s production or development laboratories, maintenance, calibration, and qualification of analytical measurement equipment, and may assist with quality control of products. The Analytical Chemist I/II will be comfortable with cGMP documentation processes, have strong critical thinking skills, and be able to accurately interpret data.

The MS&T Engineer is responsible for supporting both internal and external manufacturing and technical transfer activities to support manufacturing readiness. This includes assisting in the development of operations and maintenance procedures and other necessary documentation to ensure effective process transfer between process development and operations.   The MS&T Engineer is responsible for developing and evaluating manufacturing processes and implementing equipment and tools for production. This position will assist in the coordination of product and process improvements to meet quality and production goals.   The MS&T Engineer is a key role in relation to system management and performance ensuring that operating, maintenance strategies are optimized through sound decision making and planning, and continuously improved through feedback of operating experience and data.   The MS&T Engineer will gain an appropriate level of expertise in relation to allocated systems and equipment with an overall understanding of the drivers and limitations of system reliability and the ability to provide sound technical support, advice, and training to operations and maintenance functions.   All duties and responsibilities will be done in compliance with applicable regulatory agency standards.

The Senior Manufacturing Specialist performs equipment preparation, product dissolution, and dispensing of medical radioisotopes while complying with procedures, instructions, and prescribed routines. All projects and duties will be completed in compliance with applicable regulatory agencies, such as DOT, WI DHS, OSHA, cGMP, and FDA.   This position supports production in a 24-hour manufacturing facility which means your schedule provides days off during the week when weekend work is required.  Early morning, weekend, and some holiday work will be required with occasional overtime.

The Manager, Quality Control (QC) provides microbiological, chemical, and radiological understanding and oversight for the safe and effective processing of radiopharmaceutical drugs used to diagnose and treat diseases.  The Manager, QC will provide quality control oversight and direction from incoming material inspection and through product release. Projects and duties will be completed in compliance with applicable cGMP, cGLP, FDA, and all other applicable regulatory agencies standards.   This position supports production in a 24-hour manufacturing facility which means your schedule provides days off during the week when weekend work is required.  Early morning, weekend, and some holiday work will be required.

The primary role of this position is to conduct and validate various biological and analytical quality control assays associated with the processing of radiopharmaceutical isotopes and drugs to ensure compliance with established standards.   This role requires extensive training on radiation safety including ALARA (“as low as reasonably achievable”) principles.     The Senior Quality Control Analyst will lead various activities, as further described below.     Duties will be completed in compliance with applicable regulatory agency standards.   This position supports production in a 24-hour manufacturing facility which means your schedule provides days off during the week when weekend work is required.  Early morning, late evening, weekend, and some holiday work will be required with occasional overtime.

The Senior Manager, CDMO/CMO role will have the unique opportunity to participate in the launch of a new business within NorthStar. The Senior Manager, CDMO/CMO, will work closely with other departments to complete, staff and operationalize the CDMO facility. This role will lead the CDMO Operations team and collaborate with other support functions to meet customer demands while maintaining the facility in the highest level of Quality and Safety compliance. The Senior Manager, CDMO/CMO will work with NorthStar Senior Management to achieve the strategy, vision, and objectives for the CDMO/CMO business. In addition to the primary CDMO/CMO responsibilities, this position may be requested to lead additional projects/initiatives as directed by senior management based on skill and experience.

The Process Maintenance Technician will maintain NorthStar’s process equipment. This position will develop and execute preventive maintenance of specific production equipment including, but not limited to, cleanrooms, conveyors, hot cells, and process utility systems. This position will be working within a cGMP space and must be able to properly document and execute all activities. This position will be providing assistance to Research and Development Engineers and Process Engineers to identify, document and control equipment used in NorthStar’s cGMP defined areas.

The Senior Manufacturing Specialist, CDMO/CMO performs duties to support the development and manufacturing of various radioisotopes for NorthStar CDMO/CMO operations. This includes equipment preparation, batch/product synthesis, and aliquoting of finished patient doses while complying with procedures, instructions, and prescribed routines. All projects and duties will be completed in compliance with applicable regulatory agencies, such as DOT, WI DHS, OSHA, cGMP, and FDA.     This position supports production in a 24-hour manufacturing facility which means your schedule provides days off during the week when weekend work is required.  Early morning, weekend, and some holiday work will be required with occasional overtime.

The Automation Engineer II will contribute to the development and execution of automation engineering tasks through design, planning, procurement, and execution, as well as coordinating with vendors and contractors. Some of these tasks include programming of PLC and HMI as well as associated documentation. Also included are assisting in the development and implementation of Manufacturing Execution Systems (MES) and associated networking and data management systems. This individual will be required to work wth cross functional teams, including RA/QA and Process Engineering to apply efficient cGMP processes to preserve data integrity and the quality of the drug product, including the safety of all production and non-production personnel.   This position supports production in a 24-hour manufacturing facility and may require availability to provide support during evenings, nights, weekends, and some holidays, as needed.

The Accelerator Operator is responsible for performing routine and non-routine particle (electron) accelerator equipment operations and maintenance tasks necessary to safely, compliantly and efficiently manufacture bulk radiopharmaceuticals. This position will assist with commissioning and installation of systems and equipment, and the development of associated process procedures and instructions. Following this, the role will transition to a traditional role of routine operations and maintenance. The individual will be part of the operational success of the radioisotope production process including accelerator startup/shutdown operations and maintenance, target irradiation, and other routine operations.   This position supports production in a 24-hour manufacturing facility and will require evenings, nights, weekends, and some holidays.   Week 1 – Sunday, Tuesday, Wednesday, Thursday Week 2 – Monday, Friday, Saturday   Day shift is 6:00AM – 6:15PM and Night shift is 6:00PM – 6:15AM.  Evenings, nights, weekends and some holidays will be required with scheduled overtime every other week.

The Manufacturing Specialist performs equipment preparation, product dissolution, and dispensing of medical radioisotopes while complying with procedures, instructions, and prescribed routines. All projects and duties will be completed in compliance with applicable regulatory agencies, such as DOT, WI DHS, OSHA, cGMP, and FDA.   This position supports production in a 24-hour manufacturing facility which means your schedule provides days off during the week when weekend work is required.  Early morning, weekend, and some holiday work will be required with occasional overtime.  

The Supervisor, Accelerator Operations at the NorthStar Beloit campus is responsible for the supervision of accelerator operations including other site activities that occur during their shift. Responsibilities to include direct supervision of employees in a medical/pharmaceutical environment and ensuring compliance with cGMP standards, FDA regulations, and company policies, as well as ensuring campus safety and security.  Work hours are on a rotating 12-hour per-day PM schedule.   This position supports production in a 24-hour manufacturing facility and will require evenings, nights, weekends, and some holidays.   Week 1 – Sunday, Tuesday, Wednesday, Thursday Week 2 – Monday, Friday, Saturday   Day shift is 6:00AM – 6:15PM and Night shift is 6:00PM – 6:15AM.  Evenings, nights, weekends and some holidays will be required with scheduled overtime every other week.