Senior Radiopharmaceutical Manufacturing Specialist

1w1 week ago

NorthStar Medical Radioisotopes

Beloit, US · Full-time · $95,000 – $125,000

About this role

NorthStar Medical Radioisotopes is a commercial-stage company advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer. At the forefront of technological innovation is first-in-kind electron accelerator technology and integrated campus capabilities. The mission drives progress in radiopharmaceutical manufacturing and reliable supply of critical medical isotopes.

The Senior Radiopharmaceutical Manufacturing Specialist performs duties supporting radiopharmaceutical manufacturing, including equipment preparation, batch dissolution, product synthesis, dispensing of medical radioisotopes, and aliquoting of finished patient doses. All work complies with procedures, instructions, prescribed routines, and regulatory standards. Success requires comfort with repetitive processes, structured schedules, and production settings.

As a Subject Matter Expert, mentor new personnel on safety, quality, and production systems while assisting with batch records, audits, and production scheduling. Maintain equipment, inventory, cleanrooms, and engage in QMS workflows like deviations and CAPAs. Collaborate cross-functionally on scale-up, product development, and process improvements.

Build a meaningful career in a fast-growing field with exceptional growth and professional development opportunities. Operate in world-class facilities at the cutting edge of science. Join a rapidly expanding organization focused on life-saving radiopharmaceutical development.

Requirements

Expertise in radiopharmaceutical manufacturing processes including batch dissolution, synthesis, dispensing, and aliquoting
Proficiency with cGMP documentation and QMS guidelines for Batch Production Records, SOPs, and Work Instructions
Experience conducting safety checks on processing equipment, cleanrooms, and control systems
Knowledge of regulatory compliance standards for radiopharmaceutical production
Ability to maintain inventory, equipment traceability, and facility cleanliness per procedures
Familiarity with production scheduling, waste stream management, and post-production activities
Skills in root cause analysis, investigations, and cross-functional projects for process improvement
Comfort with repetitive processes, structured schedules, and production environments

Responsibilities

Operate as Subject Matter Expert across radiopharmaceutical manufacturing including pre-production set-up, processes, post-production activities, and waste management
Mentor and train new manufacturing personnel on safety, quality, and production systems
Assist in accurate and timely preparation of manufacturing records including Batch Records, Forms, and Log Books
Participate in internal and external compliance audits and assist with auditor interactions
Plan and organize production Work Orders on the production schedule with leadership
Author, review, and revise cGMP documents such as Batch Production Records, SOPs, Work Instructions, and Production Checklists
Perform safety checks and routine inspections of processing equipment, control systems, consumables, and cleanrooms
Engage in QMS workflows including deviations, OOSs, change controls, and CAPA using root cause analysis