Scientist, Analytical Development (mRNA)

Location: Norwood, Massachusetts, United States; 100% onsite. Only U.S. persons are eligible due to U.S. export-control requirements.

Salary: $109,200–$174,600 per year, plus potential bonus, incentive compensation, or equity.

Company

hirify.global develops mRNA technology and medicines, including vaccines and other advanced therapeutic products.

What you will do

• Lead the transfer of analytical methods from Analytical Development into Analytical Testing Operations and Quality Control laboratories.
• Assess method readiness and define phase-appropriate transfer strategies, protocols, acceptance criteria, and study designs.
• Support hands-on method reproduction, receiving-laboratory analyst training, and evaluation of analyst, instrument, site, and laboratory effects.
• Lead troubleshooting and root-cause investigations for method-performance issues, deviations, OOS/OOT events, change controls, and CAPAs.
• Create transfer packages, protocols, reports, risk assessments, training materials, and regulatory-supporting documentation.
• Develop standardized transfer playbooks and use performance trends and lessons learned to improve future analytical methods.

Requirements

• Ph.D. with 2+ years of relevant industry experience, M.S. with 8+ years, or B.S./B.A. with 12+ years in analytical development, analytical sciences, QC, or related pharmaceutical development functions.
• Strong hands-on experience developing, optimizing, and assessing the robustness and failure modes of analytical methods.
• Direct experience transferring analytical methods into GMP or GMP-supporting laboratories.
• Knowledge of analytical procedure qualification, validation, verification, lifecycle management, ICH Q2(R2), ICH Q14, USP <1224>, GMP, quality risk management, and data integrity.
• Experience with chromatography, electrophoresis, spectroscopy, compendial testing, molecular methods, bioassays, or related analytical platforms.
• Must qualify as a U.S. person under U.S. export-control requirements; visa sponsorship is not available for non-U.S. persons.

Nice to have

• Experience with mRNA, LNP, vaccines, biologics, or other advanced therapeutic modalities.
• Experience assessing laboratory-to-laboratory differences in instruments, software, reagents, standards, sample preparation, environments, and analyst technique.
• Experience supporting method remediation, lifecycle changes, and cross-functional work with QC, Quality, Regulatory, AS&T/MS&T, or external laboratories.

Culture & Benefits

• Fully onsite work model supporting direct collaboration, mentorship, and site-based laboratory operations.
• Healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health resources.
• Family planning support, including fertility, adoption, and surrogacy benefits.
• Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
• Savings and investment programs plus location-specific benefits.