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The Nuclear Pharmacist will handle radioactive materials within the scope of manufacturing and production of radiopharmaceuticals for clinical trials and commercial products. It is expected that this role will act as the subject matter expert (SME) for radiopharmaceutical preparations, and as such, will participate in routine operations and train operations staff accordingly. This includes equipment calibration, batch dissolution, product synthesis, dispensing of medical radioisotopes, and aliquoting of finished patient doses, while complying with procedures, instructions, and prescribed routines. The Nuclear Pharmacist will draw from experience and expertise to identify and...
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...
The CDMO Product Development Intern assists and supports research and development initiatives, implementation of continuous improvement projects, implementation of production equipment, and business critical projects, including production process improvements. The specific duties vary based on function. The intern will serve as a key team member performing meaningful and important work contributing to the company’s mission and the specific function’s goals.
The primary responsibility for a radiochemistry intern is to learn in a safe environment. The successful candidate should be ready and willing to take on a diverse set of tasks, under the supervision of trained NorthStar personnel. Examples of these tasks include; plan, conduct, and document laboratory experiments, prepare radioactive samples for analysis, assist NorthStar personnel in analyses utilizing complex instruments, basic radiochemical separations, create and document standard laboratory solutions, and assist in the maintenance and calibration of analytical measurement equipment.
The Quality Intern will contribute to activities related to the development of API and final drug manufacturing processes per ICH Q7 phases. Additionally, the Quality Intern will support the maintenance and management of QMS documentation development and processes such as investigations, change management, and document controls.
The Validation Engineering Intern assists and supports research and development initiatives, implementation of continuous improvement projects, implementation of production equipment, and business critical projects, including production process improvements. The specific duties vary based on function. The intern will serve as a key team member performing meaningful and important work contributing to the company’s mission and the specific function’s goals.
The Process Engineering Intern assists and supports research and development initiatives, implementation of continuous improvement projects, implementation of production equipment, and business critical projects, including production process improvements. The specific duties vary based on function. The intern will serve as a key team member performing meaningful and important work contributing to the company’s mission and the specific function’s goals.
The Mechanical Systems Engineering Intern assists and supports research and development initiatives, implementation of continuous improvement projects, implementation of production equipment, and business critical projects, including production process improvements. The specific duties vary based on function. The intern will serve as a key team member performing meaningful and important work contributing to the company’s mission and the specific function’s goals.
The MS&T Engineering Intern assists and supports research and development initiatives, implementation of continuous improvement projects, implementation of production equipment, and business critical projects, including production process improvements. The specific duties vary based on function. The intern will serve as a key team member performing meaningful and important work contributing to the company’s mission and the specific function’s goals.
The Supply Chain Analyst Intern will support in the collection and evaluation of metrics, requirements, supply chain information, and different local and global conditions to support NorthStar’s supply chain management activities.
The Chemical Process Engineering Intern assists and supports research and development initiatives, implementation of continuous improvement projects, implementation of production equipment, and business critical projects, including production process improvements. The specific duties vary based on function. The intern will serve as a key team member performing meaningful and important work contributing to the company’s mission and the specific function’s goals.
The Automation Engineering Intern assists and supports research and development initiatives, implementation of continuous improvement projects, implementation of production equipment, and business critical projects, including production process improvements. The specific duties vary based on function. The intern will serve as a key team member performing meaningful and important work contributing to the company’s mission and the specific function’s goals.
The Radiochemistry and Analytical Laboratory Supervisor will be responsible for leading the day-to-day operations for NorthStar radiochemistry and analytical laboratory teams and equipment. This role provides oversight of laboratory staffing, personnel training, lab policies and procedures, along with ensuring that projects and duties are completed in compliance with applicable cGMP, FDA, and all other regulatory agency standards.
The Health Physicist (HP) promotes NorthStar’s culture of safety by advancing radiation, health, and safety programs that embody a healthy working environment in compliance with regulations for radioactive material and electron accelerators. The HP identifies, evaluates, controls, and prevents hazards in challenging research, manufacturing, and production workplaces. All duties and responsibilities will be completed in compliance with applicable regulatory agency standards.
The EHS (Environmental, Health, and Safety) Technician is responsible for maintaining and sustaining industrial and laboratory best practice safety programs and processes associated with producing and processing radioisotopes for NorthStar’s customers at all facilities. This position will be responsible for maintaining strict compliance with OSHA and other applicable regulatory requirements. The EHS Technician is a key member of a Safety Team that includes health physics, safety, industrial hygiene, and environmental talent, and has primary responsibility for administering general safety and industrial hygiene programs.
The Chemical Process Engineer II will assist the product and process development teams with creation and implementation of simple to complex manufacturing process designs in compliance with cGMP regulations. This position will be responsible for defining and creating new procedures for documenting or qualifying equipment/processing which can be transitioned to manufacturing production engineering team members. The successful candidate will be familiar with manufacturing within a regulated industry such as medical device/pharmaceutical and possess in-depth engineering knowledge in science.
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...
The Shipping/Receiving Associate performs duties related to receiving and shipping of equipment, materials and supplies which will include radioactive and hazardous materials.
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.
This is a hands-on leadership position, accumulating and using data to make recommendations to influence decision-making and planning. The Manager, Financial Planning & Analysis will require strategic thinking and individual tactical contribution to influence and educate all levels within the organization to achieve results.
The Radiopharmaceutical Manufacturing Associate performs duties to support the development and manufacturing of radiopharmaceuticals for NorthStar operations. This includes equipment preparation, product dissolution, and dispensing of medical radioisotopes while complying with procedures, instructions, and prescribed routines. All duties and responsibilities will be completed in compliance with applicable regulatory agency standards.
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.
The Radiopharmaceutical Manufacturing Associate/Specialist performs duties to support the development and manufacturing of radiopharmaceuticals for NorthStar operations. This includes equipment preparation, product dissolution, and dispensing of medical radioisotopes while complying with procedures, instructions, and prescribed routines. All duties and responsibilities will be completed in compliance with applicable regulatory agency standards.
This position supports production in a 24-hour manufacturing facility which means...
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 with cross functional...
The Radiopharmaceutical Manufacturing Specialist performs duties to support the development and manufacturing of radiopharmaceuticals for NorthStar operations. This includes equipment preparation, product dissolution, and dispensing of medical radioisotopes while complying with procedures, instructions, and prescribed routines. All duties and responsibilities will be completed in compliance with applicable regulatory agency standards.
This position supports production in a 24-hour manufacturing facility which means your schedule...
The Supervisor, Radiopharmaceutical Manufacturing will be responsible for leading daily production activities, ensuring compliance with all regulatory standards, safety standards, and company policies. This role is responsible for delivering all types of batches, including but not limited to clinical and commercial client batches per schedule and contract obligations. This position will lead and mentor a team, efficiently allocate resources, and continuously seek to enhance production processes to optimize operational efficiency. This position plays a key role in maintaining the integrity and safety of the manufacturing environment which is essential for the successful delivery of clinical and commercial...
The Principal Radiochemist is responsible for independently planning, resourcing, executing, and reporting on campaigns of work utilizing radioactivity in order to further NorthStar’s goals and mission. This work will include analysis of radioactive samples generated in NorthStar’s production, research and development, and partner laboratories, maintenance and calibration of radiation measurement equipment, quality control testing of products, collaborating with NorthStar Quality, Regulatory, and Operations staff. The Principal Radiochemist will also share their knowledge and experience with the rest of the Science team to help grow and develop NorthStar staff.
The Senior Health Physics Technician (Sr. HPT) performs technical functions related to NorthStar’s radiation safety program under the supervision of the Lead Health Physicist. The Sr. HPT aids in mentoring and training other HPTs. The Sr. HPT work practices must comply with WI and Federal regulations, NorthStar radioactive material licenses and radiation device registrations, and NorthStar policies and procedures.
The Senior Radiopharmaceutical Manufacturing Specialist performs duties to support the development and manufacturing of radiopharmaceuticals for NorthStar operations. This includes equipment preparation, batch dissolution, product synthesis, dispensing of medical radioisotopes, and aliquoting of finished patient doses, while complying with procedures, instructions, and prescribed routines. All duties and responsibilities will be completed in compliance with applicable regulatory agency standards.