Senior Sterility Assurance Leader: Contamination Control

ModernaTX, Inc.; Norwood (MA); On-site; USD 143,000 - 257,000; Full time

Benefits offered by this job

Best-in-class healthcare

Well-being resources

Generous paid time off

Fertility and family planning support

Job summary

ModernaTX, Inc. is seeking an Associate Director, Sterility Assurance for the DP Manufacturing site in Norwood, MA.

This senior role leads the Contamination Control Strategy (CCS) and ensures aseptic operations meet regulatory expectations and quality standards on the floor. You will drive risk-based improvements across isolator operations, EM programs, and contamination control, lead investigations, author QA documentation, support regulatory inspections, and coach teams to strengthen sterile

Qualifications

• 8+ years in sterility assurance or related field
• Deep expertise in isolator-based manufacturing, EM programs, contamination control, media fills, and aseptic filling operations
• Experience with regulatory inspections, root cause investigations, and Quality System document ownership

Responsibilities

• Lead and maintain the Contamination Control Strategy (CCS) for MTC-E, ensuring alignment with EU Annex 1, FDA aseptic guidance, and internal quality expectations.
• Ensure practical, risk-based integration of the CCS into isolator operations, cleanroom design, gowning practices, material and personnel flow, environmental controls, and aseptic process execution.
• Provide sterility assurance expertise for site changes, process improvements, and operational decisions that may impact contamination control.
• Provide expert sterility assurance guidance on the EM program (strategy, zoning, sampling design, alert/action levels, and trending) and partner with QC to ensure effective monitoring and response aligned with contamination control strategy.
• Lead or support investigations with potential impact to sterility assurance (e.g., EM excursions, media fill failures, decontamination issues, bioburden or sterility failures), ensuring robust root cause analysis and effective corrective and preventive actions.
• Present EM performance, contamination control risks, and key trends to site leadership and drive data-based decision-making.

Skills

Sterility assurance

Regulatory compliance

Isolator-based manufacturing

Root-cause investigations

Education

Bachelor's degree in Microbiology, Life Sciences, Pharmacy, or related field

Master's or Ph.D. preferred

Job description

ModernaTX, Inc. is seeking an Associate Director, Sterility Assurance for the DP Manufacturing site in Norwood, MA.

This senior role leads the Contamination Control Strategy (CCS) and ensures aseptic operations meet regulatory expectations and quality standards on the floor. You will drive risk-based improvements across isolator operations, EM programs, and contamination control, lead investigations, author QA documentation, support regulatory inspections, and coach teams to strengthen sterile