Senior Manager, Analytical Development & Quality Control (Radiopharmaceuticals)

Location: Boston office, Boston, Massachusetts, United States

Salary: $175,000–$194,000 USD per year, plus annual bonus, equity participation, and benefits.

Company

hirify.global is a clinical-stage biotechnology company developing radiopharmaceuticals for targeted radiation delivery to solid tumors.

What you will do

• Lead QC data review, trending, lifecycle monitoring, and statistical analysis to support product quality and program progression.
• Manage technical relationships with external CDMOs, contract laboratories, and suppliers.
• Drive resolution of deviations, non-conformances, OOS/OOT investigations, CAPAs, and other quality events with Quality Assurance and external partners.
• Provide technical oversight for analytical development, method qualification and validation, stability studies, reference standards, and technology transfers.
• Review and approve analytical and process qualification, validation, and stability protocols and reports.
• Support raw material, precursor, API, drug product, CMC documentation, and clinical supply readiness activities.

Requirements

• Ph.D. in Analytical Chemistry, Chemistry, Radiochemistry, Pharmaceutical Sciences, or a related discipline with 6+ years of relevant industry experience, or an M.S. with 8+ years of relevant experience.
• Strong experience in analytical development, quality control, and GMP pharmaceutical development.
• Experience with external CDMOs, contract testing laboratories, and technology transfer activities.
• Knowledge of analytical method qualification, validation, transfer, lifecycle management, cGMP, ICH, and pharmaceutical regulatory requirements.
• Experience interpreting analytical, manufacturing, stability, and quality data and using statistical tools such as JMP and Excel.
• Ability to manage multiple priorities and travel up to 25% domestically and internationally.

Culture & Benefits

• Competitive salary, annual bonus, and equity participation.
• 20 vacation days, 5 sick days, paid holidays, and extended health benefits.
• Technology allowance and commuter reimbursement.
• Retirement savings plans with employer matching.
• Commitment to an inclusive workplace, equal opportunity, and reasonable accommodations.