Senior Sterility Assurance Leader, Contamination Control

BioSpace; Norwood (MA); On-site; USD 143,000 - 257,000; Full time

Benefits offered by this job

Best‑in‑class healthcare

Well‑being resources

Family planning benefits

Generous paid time off

Equity opportunities

Job summary

Moderna is seeking an Associate Director, Sterility Assurance for the DP Manufacturing site (MTC‑E) to lead the Contamination Control Strategy and ensure aseptic execution on the production floor.

The role requires deep expertise in isolator operations, EM programs, and regulatory inspections, with a focus on continuous improvement and data‑driven risk management across QA, QC, MS&T, and Operations.

Qualifications

• Bachelor’s degree in Microbiology, Life Sciences, Pharmacy or related field.
• 8+ years in sterility assurance, quality control, or aseptic manufacturing.
• Deep expertise in isolator‑based manufacturing, EM programs, and media fills.
• Experience with regulatory inspections, root cause investigations, and QA document ownership.

Responsibilities

• Lead CCS design and oversee contamination control strategy across the MTC‑E facility.
• Provide sterility assurance guidance on EM program design, sampling, and levels.
• Lead investigations and CAPAs for sterility issues and decontamination events.
• Present performance trends to site leadership and drive data‑based decisions.
• Maintain GMP records, change controls, risk assessments, and QA documentation.
• Support inspection readiness and remediation actions following audits.

Skills

Sterility assurance

Regulatory inspections

Root cause analysis

Risk assessment

Aseptic processing

Media fills

Isolator manufacturing

Quality system ownership

Education

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

Master’s or Ph.D. preferred

Job description

Moderna is seeking an Associate Director, Sterility Assurance for the DP Manufacturing site (MTC‑E) to lead the Contamination Control Strategy and ensure aseptic execution on the production floor.

The role requires deep expertise in isolator operations, EM programs, and regulatory inspections, with a focus on continuous improvement and data‑driven risk management across QA, QC, MS&T, and Operations.