Associate Director, Sterility Assurance (Aseptic Manufacturing)

Location: Norwood, Massachusetts, United States; in-person 70/30 work model with frequent manufacturing-floor presence. Only U.S. persons are eligible due to U.S. export control requirements.

Salary: $142,500–$256,500 annually, plus potential discretionary bonus, incentive compensation, or equity.

Company

hirify.global develops mRNA medicines and operates a technology platform focused on reimagining how medicines are created and delivered.

What you will do

• Lead and maintain the MTC-E Contamination Control Strategy in alignment with EU Annex 1, FDA aseptic guidance, and internal quality requirements.
• Integrate contamination controls into isolator operations, cleanroom design, gowning, material and personnel flows, environmental controls, and aseptic process execution.
• Provide sterility assurance expertise for site changes, process improvements, environmental monitoring, and operational decisions.
• Lead or support investigations involving environmental-monitoring excursions, media-fill failures, decontamination issues, bioburden, and sterility failures.
• Own quality-system documentation, including change controls, risk assessments, CAPAs, deviations, and contamination-control records.
• Support audits and regulatory inspections, conduct floor observations, coach personnel, and strengthen aseptic training and execution.

Requirements

• Bachelor’s degree in Microbiology, Life Sciences, Pharmacy, or a related field; a Master’s degree or Ph.D. is preferred.
• 8+ years of experience in sterility assurance, quality control, sterile pharmaceutical manufacturing, or aseptic processing.
• Deep expertise in isolator-based manufacturing, environmental monitoring programs, contamination control, media fills, and aseptic filling operations.
• Strong risk-assessment facilitation skills and experience with regulatory inspections, root-cause investigations, and quality-system document ownership.
• Ability to understand and apply GxP regulations, GMP requirements, Good Documentation Practices, and Data Integrity requirements.
• Must qualify as a U.S. person under U.S. export control laws; non-U.S. persons cannot be sponsored for an export-control license.

Culture & Benefits

• In-person culture with a 70/30 work model emphasizing collaboration, teamwork, and mentorship.
• Healthcare coverage and voluntary benefit programs.
• Fitness, mindfulness, mental-health, fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment opportunities, plus location-specific perks.