Sterility Assurance Program Lead

Nucleus RadioPharma; Rochester (MN); Presencial; USD 110 000 - 165 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical insurance

Dental insurance

Vision insurance

401k with employer match

Relocation assistance

Resumo da oferta

Nucleus RadioPharma in Rochester, MN is seeking a Sr. Manager of Sterility Assurance to lead microbiology, environmental monitoring, and contamination control across sterile radiopharmaceutical production.

You will mentor a growing team, shape SOPs, and drive CAPA-centered improvements to meet FDA, EMA, and global standards. The role demands strategic leadership, collaboration with Quality, Manufacturing, Engineering, and Regulatory Affairs, and active involvement in inspections, process

Qualificações

• Bachelor's degree in Life Sciences or related field required.
• Minimum 8 years' experience in sterility assurance, microbiology, or aseptic manufacturing within a GMP-regulated pharmaceutical/radiopharmaceutical environment.
• Minimum 5 years of progressive leadership managing microbiology, sterility assurance, or contamination control programs.
• Deep knowledge of FDA 21 CFR Parts 210, 211 and EU GMP Annex 1 requirements.
• Experience supporting regulatory inspections and client audits.
• Extensive experience with aseptic processing, environmental monitoring, cleanroom qualification, contamination control strategies, and microbiological investigations.
• Ability to write, review, and revise SOPs.

Responsabilidades

• Lead and mentor the Microbiology team to drive high performance.
• Oversee investigations and root-cause analyses for sterility and microbiology issues.
• Develop CAPAs to mitigate issues and improve processes.
• Provide microbiological expertise for contamination control strategies.
• Develop and manage site contamination control strategy and training programs.
• Ensure environmental monitoring trends and compliance with industry standards.
• Prepare for regulatory inspections and client audits.
• Lead readiness activities for inspections, deviations, and changes.

Conhecimentos

Sterility assurance

Microbiology

Aseptic processing

GMP compliance

Regulatory inspections

SOP writing

Environmental monitoring

Contamination control

Leadership

Project management

LIMS

eQMS

Cleanroom qualifications

Formação académica

Bachelor's degree in Life Sciences

Ferramentas

LIMS

eQMS

Cleanroom qualification

Descrição da oferta de emprego

Nucleus RadioPharma in Rochester, MN is seeking a Sr. Manager of Sterility Assurance to lead microbiology, environmental monitoring, and contamination control across sterile radiopharmaceutical production.

You will mentor a growing team, shape SOPs, and drive CAPA-centered improvements to meet FDA, EMA, and global standards. The role demands strategic leadership, collaboration with Quality, Manufacturing, Engineering, and Regulatory Affairs, and active involvement in inspections, process