CAR-T Aseptic Manufacturing Operator

Johnson & Johnson•Raritan, NJ

2d•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 a GMP-compliant cleanroom. The position works in Grade A, Grade B, and Grade C environments, with a focus on aseptic preparation and filling of autologous CAR-T products and associated patient materials. The operator must maintain product integrity and comply with aseptic, GMP, and regulatory requirements. The role includes preparing final formulations and reagents, aseptic filling into containers, operating and maintaining manufacturing equipment and laminar flow gloveboxes, inspecting product and materials, and completing accurate batch records and other documentation. The operator also performs environmental monitoring, cleanroom and equipment cleaning, and supports quality, safety, training, audit, and investigation activities in collaboration with cross-functional teams. This position requires a night-shift schedule: Wednesday/Thursday through Saturday, 6:15 PM to 6:45 AM. The operator must be able to work in comprehensive cleanroom PPE, stand for extended periods, perform precise repetitive manual tasks, and lift 2-liter bags.

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.
In-depth knowledge of aseptic techniques, GMP standards, and formulation and filling processes for biologic products and/or work within a glovebox.
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 and ability to maintain precise documentation and perform thorough inspections.
Ability to follow complex protocols and handle biologic materials carefully to avoid contamination.
Knowledge of process excellence tools.
Knowledge of routine and non-routine testing and sampling methods, techniques, and related equipment.
Knowledge and ability to operate manufacturing, manufacturing-support, and laboratory equipment.
Advanced understanding and working knowledge of required systems; ability to use MS Office and other systems to improve business effectiveness.
Accurate data-entry skills in relevant manufacturing applications, including SAP and electronic batch records.
Ability to add, subtract, multiply, and divide using whole numbers, common fractions, and decimals across units of measure.
Ability to read and interpret safety rules, operating instructions, and logbooks, and to review and provide feedback on SOP and batch-record revisions.
Ability to interpret written, oral, diagrammatic, and schedule-based instructions, follow directions, and solve practical problems in situations with limited standardization.
Ability to work in a cleanroom wearing comprehensive PPE and stand for extended periods.
Strong manual dexterity and ability to perform repetitive tasks precisely and accurately.
Ability to lift 2-liter bags.
Amenability to the specified night-shift schedule: Wednesday/Thursday through Saturday, 6:15 PM to 6:45 AM.

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, industry analysis, operational excellence, pharmaceutical industry, plant operations, process optimization, process orientation, project administration, and regulatory compliance.

Responsibilities

Follow Grade B gowning requirements and complete annual gown requalification and aseptic process requalification every six months.
Perform aseptic processing in Grade A biosafety cabinets or laminar flow gloveboxes, including open processing of human-derived materials.
Support non-commercial operations activities, including media fills, aseptic process simulations, and environmental monitoring process qualifications.
Perform daily environmental monitoring plating using agar plates and help maintain minimal action- and alert-limit excursions.
Partner with QA Micro and QASF on daily and weekly oversight checks.
Prepare final cell therapy product formulations, including buffer solutions, cryoprotectants, and other reagents, in accordance with protocols and GMP standards.
Perform aseptic filling of cell therapy products into vials, bags, or other containers while maintaining product integrity and Grade A conditions.
Operate filling equipment and verify its operation and calibration; visually inspect filled products for fill volume, container integrity, and labeling accuracy.
Perform aseptic manipulations in laminar flow gloveboxes and work with lentivirus in a BSL2+ environment.
Inspect materials for quality and sterility before, during, and after processing.
Follow electronic batch records and SOPs, and complete accurate, timely documentation according to ALCOA principles.
Maintain aseptic technique and comply with gowning, cleaning, environmental monitoring, and cleanroom requirements.
Monitor cleanroom environmental conditions, including temperature, humidity, and air quality, during filling operations.
Ensure equipment and rooms are cleaned and in service before use, and document cleaning accurately and contemporaneously.
Record and review formulation and filling activities in batch records, electronic systems, and logbooks.
Report deviations promptly and participate in investigations and resolution activities.
Operate, check, maintain, and troubleshoot formulation and filling equipment and laminar flow gloveboxes; escalate equipment issues as necessary.
Perform monthly cleaning of biosafety cabinets, laminar flow gloveboxes, and incubators, as well as ad hoc equipment cleaning.
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 for 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 the production schedule, attend meetings, assist with investigations, and participate in audit preparation and audits.
Report to work according to the shift schedule, perform other assigned duties, communicate effectively, and contribute to a positive, team-oriented environment.
Learn assigned skills, procedures, and processes and continue professional development.

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 hire date.
Sick time: 40 hours per calendar year, with different stated 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 a child's birth, adoption, or foster care placement.
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 rolling 52-week period.
Volunteer leave: 32 hours per calendar year.
Military spouse time-off: 80 hours per calendar year.