Senior Sterility & Microbiology Programs Lead
Nucleus RadioPharma
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Benefits offered by this job
Job summary
Nucleus RadioPharma in Rochester, MN, is seeking a Sr. Manager, Sterility Assurance to lead and advance the sterility assurance and microbiology programs. This full-time role involves strategic leadership in contamination control, environmental monitoring, and microbiological quality systems.
The ideal candidate will have extensive experience in sterile radiopharmaceutical manufacturing and be responsible for compliance with industry regulations. Compensation ranges from $110,000 to $165,000 per year, along with comprehensive medical and retirement benefits.
Qualifications
- Minimum 8 years’ experience in sterility assurance, microbiology, or aseptic manufacturing.
- Minimum 5 years in a leadership role managing microbiology or contamination control.
- Deep knowledge of FDA 21 CFR Parts 210, 211, and EU GMP Annex 1 requirements.
Responsibilities
- Lead and mentor the Microbiology team.
- Manage laboratory and environmental investigations.
- Conduct risk assessments and root cause analyses.
Skills
Education
Job description
Nucleus RadioPharma in Rochester, MN, is seeking a Sr. Manager, Sterility Assurance to lead and advance the sterility assurance and microbiology programs. This full-time role involves strategic leadership in contamination control, environmental monitoring, and microbiological quality systems.
The ideal candidate will have extensive experience in sterile radiopharmaceutical manufacturing and be responsible for compliance with industry regulations. Compensation ranges from $110,000 to $165,000 per year, along with comprehensive medical and retirement benefits.
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