CAR-T Aseptic Manufacturing Operator

Johnson & Johnson Innovative Medicine•Raritan, NJ

4d•$55,935 - $89,815•Onsite

About The Position

The CAR-T Aseptic Manufacturing Operator formulates and fills final cell therapy products and prepares components used for cell therapy products in GMP-compliant cleanrooms. The role involves preparing and aseptically filling autologous CAR-T products and associated patient materials in Grade A, Grade B, and Grade C environments, with careful attention to product integrity, aseptic technique, and regulatory requirements. The operator performs formulation, filling, environmental monitoring, cleaning, equipment operation and maintenance, documentation, and quality activities. Work includes aseptic processing in a biosafety cabinet or laminar flow glovebox, handling biologic materials (including lentivirus in a BSL2+ environment), completing batch records and electronic records, and supporting process simulations, qualifications, audits, and investigations. The position requires strict adherence to GMP, SOPs, gowning and cleanroom procedures, safety requirements, and documentation standards. The selected candidate must be amenable to a night-shift schedule: Wednesday/Thursday through Saturday, 6:15 PM to 6:45 AM. This position is based onsite in Raritan, New Jersey.

Requirements

High school diploma and 4–6 years of biotech/pharmaceutical experience or equivalent industry experience; or 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.
In-depth knowledge of aseptic techniques, GMP standards, and biologic product formulation and filling processes and/or glovebox work.
Familiarity with sterile filling systems, manual filling processes, equipment calibration, biosafety cabinets and/or laminar flow gloveboxes, and measuring accurate syringe volumes.
Strong attention to detail, precise documentation skills, and ability to perform thorough inspections.
Ability to follow complex protocols and handle biologic materials carefully to avoid contamination.
Knowledge of process excellence tools and routine and non-routine testing and sampling methods, techniques, and related equipment.
Ability to operate manufacturing, manufacturing-support, and laboratory equipment.
Working knowledge of required systems and accurate data entry in manufacturing applications such as SAP and electronic batch records; ability to use MS Office and other systems.
Ability to perform basic arithmetic with whole numbers, fractions, and decimals.
Ability to read and interpret safety rules, operating instructions, and logbooks, and review and provide feedback on SOP and batch record revisions.
Ability to interpret written, oral, diagrammatic, or schedule-based instructions, follow directions, and solve practical problems in situations with limited standardization.
Ability to work in a cleanroom wearing comprehensive PPE and gowning, stand for extended periods, perform repetitive precise tasks, and lift 2-liter bags.
Ability to complete Grade B gowning requalification annually and aseptic process requalification every six months.
Amenable to the specified night-shift schedule.

Nice To Haves

Preferred skills listed include accountability, agile manufacturing, analytics dashboards, chemistry, manufacturing and control (CMC), communication, data compilation, data savvy, gap analysis, good manufacturing practices (GMP), industry analysis, operational excellence, pharmaceutical industry, plant operations, process optimization, process-oriented work, project administration, and regulatory compliance.

Responsibilities

Prepare final formulations for cell therapy products in accordance with protocols and GMP standards, including preparation of buffer solutions, cryoprotectants, and other reagents.
Perform aseptic filling of cell therapy products into vials, bags, or other containers, following SOPs and Grade A cleanroom requirements.
Operate filling equipment and verify equipment operation and calibration; perform visual inspections of filled products for fill volume, container integrity, and labeling accuracy.
Perform aseptic manipulations in a biosafety cabinet or laminar flow glovebox and inspect materials for quality and sterility.
Complete and review batch records, electronic batch records, logbooks, and associated documentation accurately and contemporaneously.
Perform daily environmental monitoring plating and support environmental monitoring process qualifications, media fills, and aseptic process simulations.
Follow gowning, cleaning, environmental monitoring, and cleanroom procedures; verify cleanroom environmental conditions and document equipment and room cleanings.
Operate, inspect, clean, maintain, and troubleshoot formulation and filling equipment and laminar flow gloveboxes; conduct preventive maintenance and escalate malfunctions.
Perform monthly cleaning of biosafety cabinets, laminar flow gloveboxes, and incubators, along with other equipment cleaning as needed.
Record and report deviations, participate in investigations and resolution, and support audit preparation and participation.
Collaborate with Quality Assurance Shop Floor, Quality Control, Production Support, and the Manufacturing Supervisor to support production and product quality.
Participate in training and knowledge sharing, including training new operators.
Follow safety procedures for handling, using, and disposing of biological materials, reagents, cleaning agents, and equipment; attend safety meetings and walkthroughs and submit Good Saves.
Support production schedules by reporting according to the shift schedule, attending meetings, performing assigned duties, and working effectively with the team.
Continue learning assigned skills, procedures, and processes and develop professionally.

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, subject to policy and date of hire.
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: 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.