Director, CMC Quantitative Sciences

Location: 100% onsite in Norwood, Massachusetts, United States. Due to U.S. export control requirements, only U.S. persons are eligible.

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

Company

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

What you will do

• Define statistical strategies supporting CMC objectives, product decisions, regulatory filings, and lifecycle management.
• Design and apply experimental and statistical models for stability, comparability, expiry, and process challenges.
• Lead analytics platforms for stability monitoring, continued process verification dashboards, automated investigations, and trending.
• Oversee high-impact projects and ensure scientific quality, consistency, timelines, and methodological standards.
• Manage 5–6 statisticians and data scientists, providing mentorship, training, and long-term development.
• Partner with Process Development, Analytical Development, Quality, Manufacturing, Digital, and regulatory teams.

Requirements

• PhD with 10+ years, MS with 10–15 years, or BS with 15+ years of relevant experience in Statistics or a related discipline.
• Deep expertise in CMC statistical methods, including stability, design of experiments, regression, multivariate analysis, and control charts.
• Strong programming skills in R, Python, JMP, or SAS, plus experience deploying dashboards with tools such as Spotfire, Power BI, or Tableau.
• Experience with automated process monitoring, digital data pipelines, reproducibility, and model governance.
• Knowledge of biopharma regulatory expectations, including ICH, WHO, USP, submissions, and agency communications.
• 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.

Nice to have

• Experience with LIMS, MES, OSI PI, or SAP.
• Knowledge of GMP, phase-appropriate GMP, risk analysis, and risk-based decision-making.
• Experience with eCTD submissions, health authority questions, and formal agency meetings.

Culture & Benefits

• In-person work model supporting site-based collaboration, direct mentorship, and hands-on partnership.
• Healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health resources.
• 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 plus location-specific perks.