Senior MSAT: Radiopharmaceutical Manufacturing Leader

NorthStar Medical Technologies; Beloit (WI); On-site; USD 120,000 - 180,000; Full time

Job summary

NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer.

Join our MSAT team to lead technology transfer, process validation, investigations, and continuous improvement while collaborating with Manufacturing, Quality, and Product Development to enable commercial readiness.

Qualifications

• Bachelor’s degree in a relevant STEM field with ≥6 years in regulated manufacturing.
• Experience supporting manufacturing programs in pharma/biotech.
• Knowledge of Lean manufacturing and continuous improvement principles.
• Familiarity with regulatory audits/inspections and cGMP practices.

Responsibilities

• Serve as technical lead for technology transfer, scale-up, and product lifecycle activities.
• Provide technical oversight to manufacturing operations and lead troubleshooting.
• Lead investigations for deviations and out-of-spec results with root cause analysis.
• Contribute to change controls, CAPAs, and quality system records.
• Collaborate with Manufacturing, Quality, Product Development, Validation and others.
• Provide guidance for process characterization, validation, and continued process verification.
• Act as SME during sponsor/regulatory interactions, audits, or inspections.
• Manage complex projects with risks, timelines, and deliverables; mentor MSAT teammates.
• Lead continuous improvement initiatives using Lean and RCA methodologies.

Skills

Safety communication

Technical leadership

Cross-functional collaboration

Problem solving

Risk assessment

Lean / continuous improvement

Training / mentorship

Education

Bachelor’s degree in a relevant STEM field

Job description

NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer.

Join our MSAT team to lead technology transfer, process validation, investigations, and continuous improvement while collaborating with Manufacturing, Quality, and Product Development to enable commercial readiness.