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...

NorthStar Medical Radioisotopes, LLC seeks Mechanical Systems Engineer (Beloit, WI)   Job Description: Perform engineering duties in planning and designing tools, engines, machines, and other mechanically functioning equipment. Contributes to the design of custom production processing equipment used in the cGMP creation, processing, and...

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 position supports production in a 24-hour manufacturing facility which means your schedule...

The CDMO Product Development Technician will provide support in NorthStar’s radiologic science laboratories within the CDMO Product Development Department. Responsibilities will include maintenance and support of laboratory controls, maintenance and calibration of equipment, manifestation and disposal of radioactive material, preparation of laboratory solutions, assistance with product development/production, and general laboratory maintenance.   The CDMO Product Development Technician II will have additional responsibilities, such as...

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 Supervisor, Maintenance is responsible for development and management of the NorthStar GMP maintenance program and maintenance personnel.  The scope of the work controlled by this position includes commissioned and qualified direct and non-direct equipment and systems within NorthStar production and laboratory facilities.

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 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 regulatory agencies...

The Senior MS&T, Accelerator Support is responsible for overseeing routine maintenance and repair activities for our particle (electron) accelerators and their supporting systems/equipment; this includes planning, organizing, leading, training, and/or executing maintenance and repair on these systems. This position will also support the commissioning and installation of accelerators and supporting systems/equipment, as well as the development of procedures for associated maintenance and troubleshooting.This position must actively manage these activities with limited...

The Senior MS&T Engineer is responsible for successful internal and external manufacturing and technical transfer and operational readiness. This includes leading the development and execution of operations and maintenance procedures and other necessary documentation to ensure effective process transfer between process development and operations.   The Senior MS&T Engineer is responsible for leading the development and evaluation of manufacturing processes and implementing equipment and tools for...

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 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 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 production in a 24-hour manufacturing facility which means your schedule...