Sr. Scientist, Analytical Development (Biologics)

Location: 100% onsite in Norwood, Massachusetts, United States. Due to U.S. export control requirements, only U.S. persons are eligible; visa sponsorship is not available.

Salary: $130,800–$209,400 per year, with potential bonus, incentive compensation, or equity.

Company

hirify.global develops an mRNA technology platform and medicines, with a focus on transforming how treatments are created and delivered.

What you will do

• Serve as Analytical Program Lead for a family of clinical, registrational, and early post-approval programs.
• Define analytical strategies covering specifications, control strategies, comparability, and assay lifecycle management.
• Drive analytical readiness through method qualification, validation, transfer, and commercial control strategy implementation.
• Author and review analytical and CMC sections of IND and BLA/MAA submissions and responses to health authority questions.
• Partner with QC, Regulatory CMC, MS&T, Manufacturing, and Quality to deliver inspection-ready analytical data packages.
• Identify analytical risks, define acceptance criteria, justify strategies, and mentor team members.

Requirements

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 5+ years of relevant industry experience, or an M.S./B.S. with 8+ years of experience.
• Experience in analytical development or quality control for biologics, vaccines, or nucleic acid-based therapeutics.
• Experience with comparability strategy, specification setting, analytical control strategies, and method lifecycle management.
• Experience authoring or reviewing BLA/MAA and other regulatory CMC sections and responding to health authority queries.
• Knowledge of ICH guidelines, GMP, global regulatory expectations, method validation, technology transfer, and commercial site readiness.
• Must be eligible to access U.S. export-controlled information as a U.S. person.

Culture & Benefits

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