Senior MSAT Leader, Radiopharma CDMO

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

Benefits offered by this job

Bonus plan

Equity Incentive Program

401(k) match

Paid holidays and PTO

Healthcare benefits

Job summary

NorthStar Medical Radioisotopes in Beloit, Wisconsin is seeking a Senior MSAT, CDMO to lead technology transfer, process validation, scale-up, and commercial manufacturing. This role directs cross-functional teams and represents the organization in sponsor or regulatory discussions.

The role requires mentoring of MSAT staff, guiding root cause investigations, and driving continuous improvements to manufacturing capability and product lifecycles, while maintaining strict cGMP and safety standards.

Qualifications

• Bachelor’s degree in a relevant STEM field with several years of tech transfer/validation experience in regulated manufacturing.
• Experience supporting sponsor audits and regulatory inspections in a CDMO/pharma environment.
• Lean manufacturing and continuous improvement knowledge; ability to influence across teams.

Responsibilities

• Lead technology transfer, validation, scale-up, and commercial manufacturing activities.
• Provide technical oversight and troubleshoot manufacturing operations for safe, compliant execution.
• Develop and maintain technical documentation: protocols, reports, batch records.
• Lead investigations for deviations and CAPAs with risk assessment and root cause analysis.
• Represent the organization in sponsor/regulatory interactions and audits.
• Mentor MSAT teammates and drive continuous improvement initiatives.
• Collaborate across Manufacturing, Quality, Product Development, and Validation to support programs.
• Ensure compliance with safety and regulatory standards (cGMP/FDA, OSHA, etc.).

Skills

Technology transfer

Process validation

Scale-up

Regulatory interactions

Cross-functional leadership

Education

Bachelor’s degree in a relevant STEM field

Job description

NorthStar Medical Radioisotopes in Beloit, Wisconsin is seeking a Senior MSAT, CDMO to lead technology transfer, process validation, scale-up, and commercial manufacturing. This role directs cross-functional teams and represents the organization in sponsor or regulatory discussions.

The role requires mentoring of MSAT staff, guiding root cause investigations, and driving continuous improvements to manufacturing capability and product lifecycles, while maintaining strict cGMP and safety standards.