Principal Research Associate, Analytical Science & Technology (Analytical CMC)

Location: Norwood, Massachusetts, United States; 70% in-office work model.

Salary: $89,900–$143,800 per year, plus potential discretionary bonus, incentive compensation, or equity.

Company

hirify.global develops an mRNA technology platform and medicines intended to transform how treatments are created and delivered.

What you will do

• Coordinate analytical method validation, transfer, verification, and lifecycle management activities across late-phase development and commercial programs.
• Maintain timelines, trackers, action logs, deliverable lists, meeting records, and status updates.
• Coordinate with internal laboratories, external testing partners, Quality, Regulatory CMC, and program teams to resolve documentation and data package gaps.
• Author and revise validation plans, protocols, reports, transfer documents, method summaries, technical memoranda, and gap assessments.
• Support commercial method governance, change control, continuous improvement, regulatory submissions, health authority responses, and post-approval commitments.
• Work within regulated quality systems to ensure accurate, complete, traceable, and inspection-ready documentation.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
• At least 3 years of experience in Analytical Development, Quality Control, Analytical Sciences, or a related biopharmaceutical function.
• Experience with analytical method qualification, validation, transfer, or lifecycle management in a GMP-regulated environment.
• Working knowledge of analytical documentation for late-phase or commercial regulatory submissions, ICH guidelines, and GMP regulations.
• Strong technical writing, organizational, communication, and cross-functional collaboration skills.
• Only U.S. persons—citizens, permanent residents, asylees, or refugees—are eligible because of U.S. export control requirements; visa sponsorship for non-U.S. persons is unavailable.

Nice to have

• Experience with biologics, vaccines, or other complex modalities.
• Experience supporting validation protocols, reports, analytical method transfer documentation, or regulatory submissions.
• Experience with external laboratories, CDMOs, or global manufacturing and testing networks.
• Ability to manage multiple priorities in a fast-paced environment.

Culture & Benefits

• In-person collaboration supported through a 70/30 work model.
• Healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health resources.
• Family planning benefits, including 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 perks.