Sr. Specialist, Quality Control, Reference Material (Biopharmaceutical)

Location: Norwood, Massachusetts, United States; hybrid 70/30 work model with 70% in-office collaboration. Only U.S. persons are eligible because the role involves access to export-controlled information.

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

Company

hirify.global develops mRNA technology and medicines through biopharmaceutical research and commercial programs.

What you will do

• Execute the creation, qualification, and requalification of reference materials, assay controls, and critical reagents.
• Compile, assess, trend, and statistically analyze analytical data using Excel, JMP, and other applicable tools.
• Track material lifecycle milestones, identify risks, and coordinate sourcing, preparation, distribution, and supply continuity.
• Coordinate with QC laboratories, technical subject matter experts, and Quality stakeholders to complete GMP documentation.
• Author, revise, and review protocols, reports, certificates, regulatory submission content, and technical documentation.
• Support troubleshooting, GMP investigations, audits, and regulatory or health authority inspection activities.

Requirements

• Bachelor’s or Master’s degree in Chemical or Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, or a related discipline.
• At least 5 years of industry experience with a bachelor’s degree or 3 years with a master’s degree in biopharmaceutical development.
• Working knowledge of current FDA, EU, and ICH guidelines and regulations.
• Must qualify as a U.S. person: citizen, permanent resident, asylee, or refugee.
• Visa sponsorship for non-U.S. persons is not available.

Nice to have

• Experience supporting reference standards, critical reagents, and assay controls.

Culture & Benefits

• 70/30 in-office work model emphasizing collaboration, teamwork, and mentorship.
• Competitive healthcare and voluntary benefits.
• Fitness, mindfulness, mental health, family planning, fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
• Savings and investment programs plus location-specific benefits.