CAR T Manufacturing Operator

6062-Janssen Pharmaceuticals Legal Entity•Raritan, NJ

2d•$47,245 - $75,900•Onsite

About The Position

The CAR-T Manufacturing Operator performs manufacturing procedures and scheduled tasks for clinical and commercial autologous CAR-T production in a controlled cGMP cleanroom environment. The role is accountable for product quality and compliance with company policies, procedures, and applicable regulations. Operators handle patient blood, viruses, and patient cells in containment bags or containers and use required PPE while working in designated containment areas and cleanroom grades. Internal training and qualification are required before performing operator duties, and qualification status must be maintained; aseptic qualification may also apply. The operator performs activities including cell culturing, purification, aseptic processing, cryopreservation, welding, and sealing. The role involves working with another operator on patient-specific batches, accurately recording information in GMP documentation and electronic systems, and supporting process improvements, investigations, audits, and ongoing production. Operators follow a scheduled shift, attend meetings, maintain a safe and clean work environment, and demonstrate effective communication and teamwork. This position requires working onsite in Raritan, New Jersey, and being amenable to a specified day-shift schedule of Sunday through Tuesday, plus every other Wednesday, from 5:45 AM to 6:15 PM. The work includes prolonged standing and remaining in a cleanroom for several hours at a time, gowning for cleanroom work, and handling small instruments and vials. The anticipated base pay range is $47,245 to $75,900. Benefits described include retirement and savings plans, long-term incentives, and various paid time-off and leave programs.

Requirements

High school diploma and 4–6 years of biotech/pharmaceutical or equivalent industry experience; or an associate degree and 2–4 years of such experience; or a bachelor's degree in life sciences or engineering and 0–2 years of such experience.
Ability to read and understand English written SOPs, batch records, safety rules, operating instructions, and logbooks; English is required because systems are in English.
Working knowledge of computer systems required by the curriculum, MS Office tools, and accurate data entry in manufacturing applications such as SAP and electronic batch records.
Basic arithmetic skills, including addition, subtraction, multiplication, and division using whole numbers, fractions, and decimals.
Ability to follow written, oral, diagram, and schedule-based instructions and solve practical problems with limited standardization.
Ability to operate manufacturing, manufacturing-support, and laboratory equipment and familiarity with routine and non-routine testing and sampling methods, techniques, and related equipment.
Ability to complete required cleanroom gowning procedures and wear appropriate PPE in manufacturing and hazardous environments.
Ability to remain in a cleanroom for up to 5–6 hours at a time without gowning out and to stand for prolonged periods.
Ability to lift 25 pounds and perform duties involving standing, walking, climbing, bending, stooping, reaching, and mobility between locations.
Ability to use small instruments such as micropipettes and handle small vials.
Amenability to the specified day-shift schedule: Sunday through Tuesday plus every other Wednesday, 5:45 AM to 6:15 PM.
Ability to work effectively in a team and demonstrate interpersonal and communication skills.

Nice To Haves

Knowledge of Process Excellence tools.
Experience or familiarity with Agile Manufacturing, Manufacturing Science and Technology (MSAT), Factory Acceptance Testing (FAT), repair management, structural fabrication, prototyping, or plant operations.
Technological savvy and familiarity with manufacturing processes and mechanical equipment.

Responsibilities

Perform manufacturing tasks for clinical and commercial autologous CAR-T production in a controlled cGMP cleanroom.
Handle patient blood, viruses, and patient cells in appropriate containment areas, using required PPE and following biohazard controls.
Perform cell culturing, purification, aseptic processing, cryopreservation, welding, sealing, and related manufacturing activities using appropriate aseptic techniques.
Work collaboratively with another operator on a specific patient batch and support execution of the manufacturing process.
Record production data clearly and accurately in SOPs, logbooks, batch records, electronic systems, and other GMP documents, following GDP and ALCOA+ principles.
Complete assigned tasks on time in accordance with quality systems, cGMP requirements, and applicable regulations.
Complete internal training and qualification requirements and maintain qualification status, including aseptic qualification where applicable.
Support workshops and process-improvement programs that help develop manufacturing processes and SOPs.
Maintain a clean and safe work environment, identify and communicate hazards, and take action to address safety concerns.
Report to work on time according to the shift schedule, attend departmental and scheduled meetings, and submit PTO according to the attendance policy.
Support investigations and audit preparation and participation.
Learn new skills, procedures, and processes as assigned and continue professional development.
Use manufacturing and laboratory equipment and electronic systems, including relevant manufacturing applications.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the long-term incentive program.
Vacation: 120 hours per calendar year, subject to policy and date of hire.
Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington.
Holiday pay, including floating holidays: 13 days per calendar year.
Work, Personal and Family Time: up to 40 hours per calendar year.
Parental Leave: 480 hours within one year of the birth, adoption, or foster care of a child.
Bereavement Leave: up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver Leave: 80 hours in a 52-week rolling period.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.