Associate Director, Sterility Assurance (Biotech)

Location: Norwood, Massachusetts, United States; 70/30 in-office work model with frequent manufacturing-floor presence

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

Company

hirify.global develops mRNA-based therapeutics and vaccines using its mRNA science, delivery technology, and manufacturing platform.

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 processing.
• Provide sterility assurance expertise for environmental monitoring, site changes, process improvements, and operational decisions.
• Lead or support investigations into environmental monitoring excursions, media fill failures, decontamination issues, bioburden events, and sterility failures.
• Own quality system documentation including change controls, risk assessments, CAPAs, deviations, and contamination-control records.
• Support audit and inspection readiness, remediation activities, aseptic training, floor audits, and cross-functional risk management.

Requirements

• Bachelor’s degree in Microbiology, Life Sciences, Pharmacy, or a related field; a Master’s degree or Ph.D. is preferred.
• At least 8 years of experience in sterility assurance, quality control, sterile pharmaceutical manufacturing, or aseptic processing.
• Deep expertise in isolator-based manufacturing, environmental monitoring, contamination control, media fills, and aseptic filling operations.
• Strong risk assessment, root cause investigation, regulatory inspection, and quality system documentation experience.
• Working knowledge of GxP regulations, GMP requirements, Good Documentation Practices, and data integrity.
• Only U.S. persons—U.S. citizens, permanent residents, asylees, or refugees—are eligible due to export-control requirements; non-U.S. persons cannot be sponsored for an export-control license.

Culture & Benefits

• In-person collaboration model with 70% of work conducted in the office.
• Healthcare coverage and voluntary benefit programs.
• Fitness, mindfulness, mental health, family planning, fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment opportunities, plus location-specific benefits.