QC Analyst I/II (Cell Therapy)

Location: Raritan, New Jersey, United States; onsite role with routine evening and weekend shifts, unplanned overtime, and up to 5% domestic or international travel

Salary: $68,045–$89,308 USD base pay annually, plus performance-based bonus and/or equity for eligible roles

Company

hirify.global is a global biotechnology company developing cell therapies, including autologous, allogeneic, and in vivo platforms such as CAR-T, TCR-T, and NK cell therapies.

What you will do

• Perform QC testing for autologous CAR-T products used in clinical trials and commercial operations.
• Conduct analytical testing of raw materials, utilities, in-process samples, and final products in a controlled cGMP cleanroom environment.
• Complete peer review and approval of laboratory data using electronic LIMS systems.
• Create, review, and approve QC documents, standard operating procedures, and work instructions.
• Collaborate with Quality Assurance, Manufacturing Operations, and Analytical and Process Development teams.
• Handle biological materials and hazardous chemicals while following safety, quality, and cGMP requirements.

Requirements

• Bachelor’s degree in science, engineering, or an equivalent technical discipline.
• At least one year of relevant experience, preferably in the biological or pharmaceutical industry.
• Required knowledge of Good Tissue Practices; knowledge of cGMP regulations and FDA/EU guidance for cell-based products is strongly preferred.
• Experience with quality control, biosafety cabinets, and aseptic sample processing is preferred.
• Strong written and oral communication skills, organization, teamwork, and the ability to interact with regulatory inspectors.
• Must be authorized to work in the United States and complete Form I-9 and E-Verify requirements. Must accommodate evening/weekend shifts, unplanned overtime, and occasional travel.

Nice to have

• Knowledge of CAR-T QC test methods and related equipment.
• Experience in a quality control setting within the pharmaceutical or biotechnology industry.

Culture & Benefits

• Collaborative work with Quality Assurance, Manufacturing Operations, and Analytical and Process Development teams.
• Medical, dental, and vision insurance and a 401(k) plan with company match vesting fully on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid vacation, personal and sick time, floating holidays, and eleven company holidays.
• Benefits are available exclusively to permanent full-time employees; contractors are not eligible.