Principal Scientist, CMC Quantitative Sciences (Biotech)

Location: 100% onsite in Norwood, Massachusetts, United States

Salary: $142,500–$256,500 per year, with potential eligibility for annual bonus, incentive compensation, or equity.

Company

hirify.global develops an mRNA technology platform and medicines, supported by capabilities in biopharmaceutical research, development, manufacturing, and data science.

What you will do

• Define and execute statistical strategies supporting CMC objectives, product decisions, process development, analytical methods, and lifecycle management.
• Design and apply complex experimental and statistical models for stability, comparability, shelf-life estimation, and related CMC challenges.
• Lead a portfolio of regulatory filing, lifecycle extension, and digital analytics projects while ensuring scientific quality and delivery.
• Develop and govern stability monitoring, continued process verification dashboards, automated investigation tools, and trending platforms.
• Partner with Process Development, Analytical Development, Quality, Manufacturing, and Digital teams to embed statistical methods across the product lifecycle.
• Guide regulatory strategy and agency interactions, including responses, methodology presentations, specifications, expiry, and post-approval changes.

Requirements

• PhD in Statistics or a related STEM discipline with 5+ years of experience, or MS with 10–12 years, or BS with 12–15 years.
• 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 or data tools using platforms such as Spotfire, Power BI, or Tableau.
• Experience with automated process monitoring, digital data pipelines, model governance, and reproducible data practices in GMP and non-GMP environments.
• Familiarity with ICH, FDA, EMA, WHO, and USP expectations, regulatory submissions, and health authority communications.
• Must work onsite in Norwood, Massachusetts; access to export-controlled information is subject to U.S. export-control requirements.

Nice to have

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

Culture & Benefits

• In-person collaboration, direct mentorship, and hands-on partnership at a site-based operation.
• Healthcare coverage and voluntary benefit programs.
• Fitness, mindfulness, mental health, family planning, fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment programs, plus location-specific perks.