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This position will support NorthStar’s Beloit, WI campus with respect to Plant Engineering functions. This position will act as the technical leader for facility and utility installations and commissioning, as well as execute capital and continuous improvement projects for the facilities in support of cGMP operations. This position will also be the Facilities department...
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.
This...
The Director, Business Development, CDMO/CMO holds a critical role in managing business development-related responsibilities for NorthStar’s CDMO/CMO business including producing, reviewing, and negotiating all associated contracts and agreements. This role is responsible for working with prospects and sponsors to understand their requests and needs, while including pricing and timeline considerations, and working seamlessly with internal stakeholders as liaisons for the sponsors. The Director, Business Development, CDMO/CMO is accountable for developing and replying to proposals and securing logistical and contractual details, as...
The Radiopharmaceutical Development Scientist will support both CDMO product development and related projects. Specifically, the candidate will oversee activities related to radiopharmaceutical drug development, formulation testing, technology transfer, and cGMP manufacturing. This includes but is not limited to radiolabeling, quality control testing, laboratory controls, conducting design of experiments, cross-training, and authoring of associated documentation. This individual will participate directly with customers to understand and provide contract development services to meet company objectives and timelines in support of CDMO product development and...
The Health Physics Technician (HPT) performs technical functions related to NorthStar’s radiation safety program under the supervision of the Radiation Safety Officer (RSO) & Lead Health Physicist. HPT work practices must comply with WI and Federal regulations, NorthStar radioactive material licenses and radiation device registrations, and NorthStar policies and procedures.
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 clinical trial and commercial manufacturing of radiopharmaceuticals used in...
This position will shepherd Contract Development and Manufacturing Organization (CDMO) projects through their life cycle at NorthStar, including initial kickoff, technology transfer, validation, and drug product manufacturing, both clinical and commercial. The CDMO Project Manager is responsible for providing internal and external leadership for CDMO projects. This role will serve as the main contact for driving the tactical execution of CDMO projects upon contract approvals. This role may also provide support to the Commercial organization in the outreach and courting of new sponsors.
The role of the Senior Regulatory Affairs Specialist is to manage regulatory, quality, and business issues to permit NorthStar to develop, produce, and distribute medical radioisotopes and radiopharmaceuticals that comply with U.S. Food and Drug Administration (FDA) and other applicable requirements. The Senior Regulatory Affairs Specialist will have primary responsibility to handle day-to-day activities related to FDA electronic submissions for drug marketing approvals. This role will also work with the Vice President, Quality and Regulatory to develop NorthStar regulatory and quality strategy.
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 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 primary role of this position is to provide support to various quality aspects associated with the processing of radiopharmaceutical isotopes and radiologic science laboratories within the Quality Control team. The role will focus on support activities, such as sampling, general GMP laboratory testing/support, manufacturing operations, and batch release testing of radioactive products. This role requires extensive training on radiation safety including ALARA (“as low as reasonably achievable”) principles.
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 development and manufacturing of radiopharmaceuticals used in time-sensitive...