Associate Director, Sterility Assurance

Moderna

Remote
Base: $142,500.00 - $256,500.00; bonus/equity: eli...
Remote
Contamination control strategy (ccs) program
Aseptic manufacturing best practices
Environmental monitoring (em) program
Moderna is seeking an Associate Director of Sterility Assurance for their remote position, responsible for overseeing the Contamination Control Strategy (CCS) program at the MTC-E facility. The role requires extensive experience in sterility assurance, quality control, and aseptic processing, focusing on compliance and continuous improvement in manufacturing

Job Summary

  • This senior technical role is accountable for the design, implementation, and oversight of the site’s Contamination Control Strategy (CCS) program, ensuring sterility assurance activities align with regulatory expectations.
  • The Associate Director partners closely with Manufacturing, MS&T, Facilities, QC, Engineering, Supply Chain, and Quality to integrate sterility assurance into all layers of site operations.
  • The role requires frequent presence on the manufacturing floor to observe, assess, and improve aseptic behaviors, process execution, and contamination control practices.

Matching Summary

Match Score: 85

Moderna is seeking an Associate Director of Sterility Assurance for their remote position, responsible for overseeing the Contamination Control Strategy (CCS) program at the MTC-E facility. The role requires extensive experience in sterility assurance, quality control, and aseptic processing, focusing on compliance and continuous improvement in manufacturing.

Salary

Base: $142,500.00 - $256,500.00; Bonus/Equity: Eligible for annual discretionary bonus, other incentive compensation, or equity award; Benefits: Best-in-class healthcare, holistic well-being support, family planning, generous PTO, savings and investment opportunities

Skills & Requirements

Must-have

  • Contamination Control Strategy (CCS) program
  • aseptic manufacturing best practices
  • environmental monitoring (EM) program
  • investigation of sterility failures
  • Good Documentation Practices (GDP)

Nice-to-have

  • hands-on manufacturing floor presence
  • data-driven decision-making
  • cross-functional collaboration
  • continuous improvement initiatives

Key Requirements

  • Bachelor's degree in Microbiology, Life Sciences, Pharmacy, or related field
  • 8+ years in sterility assurance, quality control, sterile pharmaceutical manufacturing, or aseptic processing
  • Expertise in isolator-based manufacturing, EM programs, contamination control, media fills, and aseptic filling operations
  • Strong expertise in risk assessment facilitation
  • Direct involvement in regulatory inspections, root cause investigations, and Quality System document ownership

Work Rights

Must be a U.S. person

Tailored Resume

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