Lead Radiopharmaceutical Manufacturing Specialist

NorthStar Medical Radioisotopes; Beloit (WI); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) match

Paid holidays and PTO

Bonus plan

Equity Incentive Program

Job summary

NorthStar Medical Radioisotopes in Beloit, Wisconsin seeks a Senior Radiopharmaceutical Manufacturing Specialist to lead manufacturing of radiopharmaceuticals, from intermediate processes to finished doses, ensuring compliance with cGMP and quality standards.

You will mentor staff, manage batch records, and participate in audits, while coordinating with leadership on production schedules and continuous process improvement.

Qualifications

• Associate’s Degree in a STEM discipline and minimum four years of cGMP experience, or equivalent.
• Bachelor’s Degree in a STEM discipline and minimum four years of cGMP experience preferred.
• CDMO/CMO experience, chemistry experience and aseptic awareness are a plus.
• Immigration sponsorship not provided; form I-9 completion required on first day.

Responsibilities

• Operate as SME across radiopharmaceutical manufacturing processes from pre-production to waste stream management.
• Mentor and train new manufacturing personnel on safety, quality, and production systems.
• Prepare and complete Batch Records, Forms, Log Books and related documentation timely.
• Support internal and external audits and auditor interactions as needed.
• Plan Work Orders with leadership to align production on schedule.
• Author and revise BPR, SOP, WI, and Production Checklists under QMS guidelines.
• Perform safety checks on equipment, identify issues, and coordinate materials or investigations.
• Maintain accurate inventory and equipment traceability.
• Ensure cleanliness and orderliness of facility and equipment.
• Engage in deviations, OOSs, change controls, DCOs, CAPA; apply root cause analysis.
• Contribute to projects on scale-up, product development, and process improvements.
• Coordinate with Facilities for preventative maintenance and calibration tracking.
• Monitor product quality and communicate abnormalities to leadership.

Skills

cGMP experience

radiopharmaceutical manufacturing

documentation accuracy

Education

AS in STEM with 4+ years cGMP experience

BS in STEM with 4+ years cGMP experience

Tools

QMS documentation

Batch Records (BPR)

SOP/WI management

Job description

NorthStar Medical Radioisotopes in Beloit, Wisconsin seeks a Senior Radiopharmaceutical Manufacturing Specialist to lead manufacturing of radiopharmaceuticals, from intermediate processes to finished doses, ensuring compliance with cGMP and quality standards.

You will mentor staff, manage batch records, and participate in audits, while coordinating with leadership on production schedules and continuous process improvement.