Manufacturing Lead Operator, Aseptic Process (CAR-T)

Location: Raritan, New Jersey, United States; onsite manufacturing role with assigned production shifts, including evenings and weekends as required.

Salary: $83,711–$109,870 USD base pay annually, plus performance-based bonus and/or equity where applicable.

Company

hirify.global is a biotechnology company developing cell therapies, including CAR-T, TCR-T, NK cell-based, and other platforms for serious diseases.

What you will do

• Perform cell culture, purification, aseptic processing, and cryopreservation unit operations for personalized CAR-T products.
• Work in specialized BSL-2+ ISO 5 and ISO 7 cleanroom environments while following SOPs, batch records, GMP quality systems, and regulatory requirements.
• Provide production-floor oversight for BCMA CAR-T cell therapy operations and record manufacturing data accurately.
• Troubleshoot patient-specific product issues and maintain safe, timely, and continuous operations.
• Support manufacturing process development, risk analyses, change management, continuous improvement, and corrective and preventive actions.
• Collaborate with Manufacturing, Engineering, Quality, Technical Operations, and external stakeholders in a cross-functional matrixed environment.

Requirements

• Bachelor’s degree in life science, engineering, or a related field, or equivalent experience.
• At least 2 years of operations experience in a cGMP biotech or biopharmaceutical environment; experience in manufacturing, maintenance, quality, testing, or engineering is required.
• Knowledge of cGMP regulations and FDA guidance for manufacturing cell-based products; aseptic manufacturing experience is preferred.
• Applicants must be authorized to work in the United States; employment eligibility is verified through Form I-9 and E-Verify.
• Ability to work independently, manage competing priorities, communicate clearly, and collaborate across functions.
• Ability to lift at least 50 pounds, stand for extended periods, handle human-derived materials and hazardous chemicals, and meet the stated vision, hearing, and dexterity requirements.

Nice to have

• Prior experience in an aseptic manufacturing environment.
• Working knowledge of AI technologies and approved AI tools, with responsible human oversight of AI-generated outputs.

Culture & Benefits

• Permanent full-time employees receive medical, dental, and vision insurance.
• Benefits include a 401(k) plan with company match, paid parental leave, paid time off, and company holidays.
• Additional benefits include flexible spending and health savings accounts, disability coverage, life insurance, commuter benefits, and family-care resources.
• Contractors are not eligible for hirify.global benefits.