Principal Research Associate, Analytical Development (Vaccines)

Location: Norwood, Massachusetts; 100% onsite. Only U.S. persons are eligible to access export-controlled information.

Salary: $89,900–$143,800 per year, with potential eligibility for a discretionary bonus, incentive compensation, or equity award.

Company

hirify.global develops mRNA medicines and vaccines through its mRNA technology platform.

What you will do

• Support analytical control strategies and regulatory deliverables for vaccine development and lifecycle programs.
• Author, review, and maintain analytical CMC content covering methods, specifications, stability, characterization, comparability, and control strategies.
• Coordinate responses to health-authority questions, including scientific evidence, SME input, comments, commitments, and finalization.
• Support Annual Strain Update activities for new vaccine strains or variants, including method suitability, reference standards, release and stability data, characterization, comparability, and filing packages.
• Maintain trackers for deliverables, source documents, data availability, decisions, risks, dependencies, and regulatory commitments.
• Coordinate with Analytical Development, Analytical Sciences, Product Characterization, Clinical Stability, Process Development, QC, Quality, Regulatory CMC, and Quantitative Sciences to produce accurate, traceable, filing-ready content.

Requirements

• M.S. with 5+ years or B.S./B.A. with 8+ years of relevant biotechnology or pharmaceutical industry experience.
• Experience in Analytical Development, CMC, Quality, regulatory support, or a related technical development function.
• Scientific understanding of analytical development for biologics, vaccines, nucleic-acid therapeutics, or other advanced modalities.
• Experience with analytical methods, specifications, stability, characterization, comparability, critical quality attributes, and analytical control strategies.
• Strong technical writing, data interpretation, organization, cross-functional collaboration, and project-execution skills.
• Must qualify as a U.S. person under U.S. export-control requirements; non-U.S. persons are not eligible for this position.

Nice to have

• Experience preparing CMC regulatory submissions, analytical filing content, health-authority responses, or other regulatory-facing technical documentation.
• Experience supporting Analytical Program Leads, CMC product leads, Regulatory CMC leads, or similar technical leadership roles.
• Vaccine development experience, including seasonal vaccines, strain changes, variant updates, or accelerated filing cycles.
• Familiarity with FDA, EMA, ICH, pharmacopeial, GMP, data-integrity, and document-control expectations.
• Experience with Veeva, LIMS, electronic notebooks, or controlled-document platforms.

Culture & Benefits

• 100% onsite work to support direct collaboration and site-based operations.
• Healthcare and voluntary benefit programs.
• Fitness, mindfulness, mental-health, and family-planning support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
• Savings and investment programs, plus location-specific benefits.