QC Analyst I/II (CAR-T)

Location: Raritan, New Jersey, United States; onsite. Routine evening and weekend shifts, unplanned overtime, and up to 5% domestic or international travel may be required.

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

Company

hirify.global is a biotechnology company developing cell therapies, including CAR-T, TCR-T, and natural killer cell-based therapies, in collaboration with Johnson & Johnson on CARVYKTI.

What you will do

• Perform QC testing for autologous CAR-T products supporting clinical trials and commercial manufacturing in a controlled cGMP cleanroom environment.
• Conduct analytical testing of raw materials, utilities, in-process samples, and final products.
• Perform peer review and approval of laboratory data using LIMS and other electronic systems.
• Create, review, and approve QC documents, SOPs, and work instructions.
• Collaborate with Quality Assurance, Manufacturing Operations, and Analytical/Process Development.
• Handle biological materials and hazardous chemicals in accordance with 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.
• Knowledge of Good Tissue Practices; knowledge of cGMP regulations and FDA/EU guidance for cell-based products is strongly preferred.
• Experience with biosafety cabinets and aseptic sample processing is strongly preferred; CAR-T QC test methods and related equipment experience 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 shifts, routine weekend and evening work, and unplanned overtime.

Culture & Benefits

• Permanent full-time employees receive medical, dental, and vision insurance and a 401(k) plan with company match fully vested on day one.
• Benefits include eight weeks of paid parental leave after three months, paid vacation and sick time, floating holidays, and eleven company holidays.
• Additional benefits include flexible spending and health savings accounts, disability and life insurance, commuter benefits, family planning resources, and well-being initiatives.
• Work takes place in a collaborative quality and manufacturing environment with shifting priorities and cross-functional interaction.