Associate Director, Sterility Assurance

Moderna Inc

Base: $142,500.00 - $256,500.00; bonus/equity: eli...
8+ years sterility assurance experience
Deep expertise in isolator-based manufacturing
Lead contamination control strategy (ccs)
This senior technical role is accountable for the design, implementation, and oversight of the site's Contamination Control Strategy program aligned with EU Annex 1 and FDA guidance

Job Summary

  • This senior technical role is accountable for the design, implementation, and oversight of the site's Contamination Control Strategy program aligned with EU Annex 1 and FDA guidance.
  • The successful candidate will lead investigations into sterility failures, manage environmental monitoring programs, and serve as a key leader in inspection readiness activities.
  • Moderna offers best-in-class healthcare coverage, generous paid time off including sabbaticals, and a holistic approach to well-being with fitness and mental health support.

Matching Summary

Match Score: 75

This senior technical role is accountable for the design, implementation, and oversight of the site's Contamination Control Strategy program aligned with EU Annex 1 and FDA guidance.

Salary

Base: $142,500.00 - $256,500.00; Bonus/Equity: Eligible for annual discretionary bonus and equity award; Benefits: Best-in-class healthcare, family planning, PTO, and wellness resources

Skills & Requirements

Must-have

  • 8+ years sterility assurance experience
  • Deep expertise in isolator-based manufacturing
  • Lead Contamination Control Strategy (CCS)
  • Expertise in EM program and media fills
  • Direct regulatory inspection involvement

Nice-to-have

  • Strong risk assessment facilitation skills
  • Proactive continuous improvement mindset
  • Data-driven decision-making aptitude
  • Hands-on floor observation capability

Key Requirements

  • Bachelor's degree required; Master's or Ph.D. preferred
  • 8+ years in sterility assurance or sterile pharmaceutical manufacturing
  • Must be a U.S. person (citizen, permanent resident, etc.) due to export controls

Work Rights

Must be a U.S. person (citizen, permanent resident, asylee, or refugee)

Tailored Resume

Cover Letter