Radiopharmaceutical Manufacturing Specialist — 24/7 Ops

Nucleus RadioPharma; Rochester (MN); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental & Vision

Health Savings Account

401k with match

Relocation assistance

Paid time off

Job summary

Nucleus RadioPharma in Minnesota seeks a Manufacturing Specialist to oversee routine CGMP manufacturing of radiopharmaceuticals, perform cleaning, preparation, formulation, dispensing, packaging, and maintain procedures. You will coordinate production runs, train staff, ensure quality and safety, and collaborate with R&D, QA, and safety to update SOPs.

Candidates need BS in STEM and 2+ years in FDA CGMP environment; willingness to work nights/weekends.

Qualifications

• Bachelor's degree in a STEM field or equivalent experience.
• Minimum 2 years in an FDA CGMP environment (21 CFR Parts 210 and 211).
• Experience in aseptic processing and radiopharmaceuticals.
• Strong mechanical aptitude and troubleshooting skills.
• Ability to work in a 24/7 manufacturing setting, including nights/weekends.

Responsibilities

• Lead and support manufacturing in a fast-paced facility, aligning with goals and QA standards.
• Ensure compliance with CGMP, CFR guidelines, and safety requirements.
• Perform cleaning, equipment setup, daily checks, and aseptic operations.
• Schedule production runs and coordinate staffing for 24/7 operations.
• Develop and update SOPs with cross-functional teams (R&D, QA, Safety).
• Train personnel and document activities to meet sponsor requirements.

Skills

CGMP

Aseptic processing

Radiopharmaceuticals

Troubleshooting

Team coordination

Mechanical aptitude

Education

Bachelor's degree in STEM

2+ years FDA CGMP experience

Tools

Hot cells

Automated processing equipment

Job description

Nucleus RadioPharma in Minnesota seeks a Manufacturing Specialist to oversee routine CGMP manufacturing of radiopharmaceuticals, perform cleaning, preparation, formulation, dispensing, packaging, and maintain procedures. You will coordinate production runs, train staff, ensure quality and safety, and collaborate with R&D, QA, and safety to update SOPs.

Candidates need BS in STEM and 2+ years in FDA CGMP environment; willingness to work nights/weekends.