Director, CMC Quantitative Sciences (Biopharma)

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, with potential eligibility for bonus, incentive compensation, or equity.

Company

hirify.global develops an mRNA technology platform and medicines through research, manufacturing, and data-driven innovation.

What you will do

• Lead a team of 5–6 CMC statisticians and data scientists across product development, regulatory filings, lifecycle management, manufacturing, and stability programs.
• Define statistical strategies and provide expert consultation for product, process, and business decisions.
• Design complex experimental and statistical models for stability, comparability, lifecycle management, shelf-life estimation, and root cause analysis.
• Oversee analytics platforms for stability monitoring, continued process verification dashboards, automated investigations, and trending.
• Guide regulatory strategies, submissions, agency responses, and formal presentations on specifications, comparability, expiry, and post-approval changes.
• Establish standards for data creation, integration, pipelining, reproducibility, and model governance across GMP and non-GMP environments.

Requirements

• PhD with 10+ years of relevant experience, MS with 10–15 years, or BS with 15+ years in Statistics or a related discipline.
• Deep expertise in CMC statistical methods, including stability analysis, DOE, regression, multivariate analysis, and control charts.
• Strong programming skills in R, Python, JMP, or SAS, plus experience deploying dashboards or analytical tools.
• Experience with automated process monitoring, digital data pipelines, model governance, and biopharmaceutical regulatory expectations including ICH, WHO, and USP.
• Proven leadership, mentoring, communication, and ability to teach statistical methods to non-statisticians.
• Must work onsite in Norwood, Massachusetts, and qualify as a U.S. person under applicable export control laws.

Nice to have

• Experience with LIMS, MES, OSI PI, SAP, or other manufacturing and analytical systems.
• Knowledge of GMP quality concepts, phase-appropriate GMP principles, risk analysis, and risk-based decision-making.
• Experience with eCTD submissions, health authority questions, agency meetings, and regulatory interactions.

Culture & Benefits

• In-person work model focused on close collaboration, mentorship, and site-based operations.
• Healthcare and voluntary benefit programs.
• Fitness, mindfulness, mental health, family planning, fertility, adoption, and surrogacy support.
• Paid time off, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
• Savings and investment programs, plus location-specific benefits.