Director, CMC Stability (mRNA)

Location: Onsite at hirify.global’s Technology Center campus in Norwood, Massachusetts, United States. Only U.S. persons are eligible due to U.S. export control requirements; non-U.S. persons cannot be sponsored for an export control license.

Salary: $167,000–$300,700 per year, plus potential bonus, incentive compensation, or equity.

Company

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

What you will do

• Lead the end-to-end CMC Stability function across non-clinical-enabling, clinical, and commercial programs.
• Translate target product profile expectations into stability studies, storage conditions, shelf-life claims, and lifecycle strategies.
• Oversee stability data trending, statistical analysis, expiry assessments, reviews, forecasting, dashboards, and portfolio metrics.
• Provide technical leadership for out-of-trend investigations, atypical observations, temperature and shipping excursions, deviations, and comparability assessments.
• Author and review stability sections for regulatory submissions, annual reports, post-approval supplements, and health authority responses.
• Build operating models, govern portfolio prioritization, and lead, mentor, and develop stability staff.

Requirements

• Degree in life sciences, chemistry, biochemistry, pharmaceutical sciences, chemical engineering, bioengineering, or a related technical discipline.
• 15 years of relevant experience with a bachelor’s degree, or 10 years of relevant experience with a PhD.
• Deep stability expertise across development, registration, commercial launch, and lifecycle management for biologics, vaccines, mRNA or nucleic-acid therapeutics, or other complex modalities.
• Knowledge of global stability guidance, including ICH Q1A–Q1E, accelerated and long-term stability design, statistical shelf-life assessment, and bracketing and matrixing.
• Experience with regulatory stability sections, health authority responses, regulatory commitments, stability investigations, and product risk management.
• Strong cross-functional and people leadership skills in a matrixed environment.

Nice to have

• PhD in a relevant scientific or engineering discipline.

Culture & Benefits

• 70/30 in-office work model emphasizing collaboration, innovation, and direct mentorship.
• Healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment programs, with location-specific perks.