Associate Director, Stability Lead Development & Clinical (mRNA)

Location: Norwood, Massachusetts, United States; 70% in-office work model. Only U.S. persons are eligible due to U.S. export control requirements.

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

Company

hirify.global develops mRNA medicines and operates a broad pipeline spanning research, development, manufacturing, and commercial delivery.

What you will do

• Define and lead phase-appropriate stability strategies across development, clinical, and commercial mRNA programs.
• Design and oversee stability protocols and study plans supporting IND/CTA submissions, registration packages, post-approval commitments, and lifecycle initiatives.
• Review stability data through statistical evaluation and trending analysis to support shelf-life, expiry, storage-condition, and risk-based decisions.
• Identify degradation trends, product risks, and supply vulnerabilities, and lead mitigation strategies with cross-functional partners.
• Author and review stability content for regulatory submissions and health authority responses.
• Lead OOS/OOT investigations, risk assessments, process improvements, and matrix-team decisions across technical, quality, regulatory, supply, and commercial functions.

Requirements

• Degree in life sciences, chemistry, engineering, pharmaceutical sciences, or a related technical discipline.
• 12 years of relevant experience with a bachelor's degree, or 5 years of relevant experience with a PhD.
• Significant stability-strategy experience with biologics, vaccines, or other complex drug products.
• Experience with regulatory submissions, health authority interactions, statistical analysis, stability trending, expiry dating, and storage-condition decisions.
• Experience leading investigations, change assessments, formal risk evaluations, and cross-functional CMC activities.
• Must qualify as a U.S. person; hirify.global cannot sponsor non-U.S. persons for an export control license.

Nice to have

• Advanced degree in a relevant field with 7 or more years of relevant industry experience.
• Experience with post-approval or commercial lifecycle management.
• Experience improving stability processes, governance, or operating models.
• Experience using digital tools, advanced analytics, or generative AI capabilities.

Culture & Benefits

• In-person collaboration supported through a 70/30 work model.
• Healthcare coverage and voluntary benefit programs.
• Fitness, mindfulness, and mental health resources.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid time off, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment opportunities, plus location-specific benefits.