Director, CMC Stability (Biotech)

Location: Onsite at hirify.global’s Technology Center campus in Norwood, Massachusetts, United States. Only U.S. persons 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, with potential discretionary bonus, incentive compensation, or equity award.

Company

hirify.global develops an mRNA technology platform and medicines designed to transform how treatments 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 strategies, shelf-life claims, storage conditions, and lifecycle requirements.
• Design and oversee stability studies supporting clinical advancement, regulatory approvals, commercial launch, and post-approval lifecycle management.
• Direct stability data trending, statistical analysis, expiry assessments, forecasting, dashboards, and portfolio-level metrics.
• Provide technical leadership for out-of-trend investigations, temperature excursions, deviations, comparability questions, and product risk assessments.
• Lead cross-functional collaboration and develop a high-performing team of stability leads and associates.

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 expertise in stability strategy and execution for biologics, vaccines, mRNA or nucleic acid-based therapeutics, drug products, 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 IND/CTA/BLA/MAA stability sections, health authority responses, annual reports, post-approval supplements, and regulatory commitment management.
• Strong people leadership, communication, executive presence, and stakeholder management skills in a matrixed environment.

Nice to have

• PhD in a relevant scientific or engineering discipline.
• Experience developing stability workflows, governance models, dashboards, capacity forecasts, and operational metrics.
• Experience leading work across Analytical Development, Quality, Regulatory CMC, Manufacturing, MS&T, Clinical Supply, Commercial Supply, and product teams.

Culture & Benefits

• 70/30 in-office work model emphasizing in-person collaboration, innovation, teamwork, and mentorship.
• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, mental health, family planning, fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
• Savings and investment programs plus location-specific perks.