Aseptic Manufacturing Operator CAR-T

Johnson & Johnson Innovative Medicine•Raritan, NJ

1d•Onsite

About The Position

The CAR-T Aseptic Manufacturing Operator at Johnson & Johnson's Innovative Medicine sector in Raritan, NJ, is responsible for the formulation and filling of final cell therapy products or the preparation of components used for cell therapy products. This work is conducted within a GMP-compliant cleanroom environment, specifically Grade C, Grade B, and Grade A cleanrooms. The primary focus of this role is the aseptic preparation and filling of autologous CAR-T products and associated components for patient material. The operator must perform all steps with precision to maintain product integrity, requiring a high level of expertise in aseptic techniques, meticulous attention to detail, and strict adherence to Good Manufacturing Practices (GMP) and regulatory requirements. The ultimate goal is to produce a safe and effective cell therapy. The role involves working in a BSL2+ environment when handling lentivirus in a laminar flow glovebox and requires adaptability to real-time changes, composure under pressure, and flexibility in scheduling due to the variability of patient material and processes. Meeting strict time constraints while maintaining aseptic conditions is crucial.

Requirements

HS Diploma required with 4-6 Years of Biotech/Pharmaceutical experience or equivalent industry experience OR Associate degree required with 2-4 Years of Biotech/Pharmaceutical experience or equivalent industry experience. OR Bachelor’s degree required in Life Sciences or Engineering, with 0-2 years of Biotech/Pharmaceutical experience or equivalent industry experience.
Advanced understanding and working knowledge of systems required per curriculum.
Utilizes tools within MS Office and other systems to improve business effectiveness.
Accurate Data Entry skills in relevant manufacturing applications (SAP, electronic batch records (EBR), etc.).
Ability to add, subtract, multiply and divide into all units of measure, using whole numbers, common fractions, and decimals.
Ability to read and interpret documents such as safety rules, operating instructions, and logbooks.
Ability to review and provide feedback for SOP and Batch Record Revisions.
Ability to work in a cleanroom environment, wearing appropriate (comprehensive) personal protective equipment (PPE), while regularly standing for extended periods of time.
Strong manual dexterity and ability to perform repetitive tasks with precision and accuracy.
Ability to lift 2L bags.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to follow instructions.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
In-depth knowledge of aseptic techniques, GMP standards, and the formulation and filling processes for biologic products and/or within a glovebox.
Familiarity with sterile filling systems, manual filling processes, equipment calibration, working in a BSC and/or LFG, and measuring accurate syringe volumes.
Strong attention to detail with the ability to maintain precise documentation and perform thorough inspections.
Ability to follow complex protocols, and handle biologic materials with care to avoid contamination.
Knowledge of Process Excellence Tools.
Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques, and related equipment.
Knowledge and ability to operate manufacturing, manufacturing-support, and lab equipment.
Flexibility to support first (7 AM to 6:30/7 PM) or second shift (1 PM to 12:30/1 AM) schedules as business needs require.

Nice To Haves

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
Project Administration
Regulatory Compliance

Responsibilities

Follow Grade B gowning requirements (PPE requiring coveralls, bouffant, boots, etc.), while completing gown (re)qualification on an annual basis.
Perform aseptic processing within a (Grade A) Biosafety Cabinet or Laminar Flow Glovebox - open process with human derived materials where maintaining complete sterility is of the utmost importance.
Support non-Commercial Operations activities such as Media Fills, Aseptic Process Simulations, Environmental Monitoring Process Qualifications etc. in Grade B or Grade C environment.
Successfully meet all requirements during an extended initial training period; Aseptic Process requalification every 6-months.
Perform deft hand-manipulation technique / hand-eye coordination.
Adapt to change in real-time and remain composed under pressure; be flexible in schedule due to variability in the product (patient material / process).
Meet strict time constraints – prioritize required activities while still maintaining aseptic conditions.
Perform daily comprehensive environmental monitoring (EM) plating using agar plates, while maintaining minimal Action and Alert Limit EM excursions.
Partner with QA Micro and QASF in support of performing daily / weekly oversight checks to ensure practices are upheld.
Operate notable equipment: Centrifuge, Serological pipettes, repeater pipettes, sealers, Visual Inspection, MetOne particle counter, MAS100 air sampler, tube welders.
Prepare final formulation for a cell therapy product in compliance with prescribed protocols and GMP standards.
Perform aseptic formulation procedures, including the preparation of buffer solutions, cryoprotectants, and other key reagents, ensuring proper mix and concentration.
Ensure that the final product meets all specifications for viability, sterility, and quality before it enters the filling process.
Perform aseptic filling of a cell therapy product into vials, bags, or other containers, ensuring no contamination or loss of product integrity.
Ensure all filling activities are performed according to SOPs and in compliance with Grade A cleanroom conditions.
Operate filling equipment, such as manual devices, ensuring proper operation and calibration.
Perform visual inspections of filled products to confirm proper fill volume, container integrity, and labeling accuracy.
Complete and review batch records and associated documentation for all formulation and filling activities.
Perform aseptic manipulations within a laminar flow glovebox (LFG) consisting of vials, bags, or other containers, ensuring no contamination or loss of product integrity.
Operate comfortably working with lentivirus in a BSL2+ environment.
Inspect all materials for high quality and sterility before, during and after processes.
Follow EBR and SOPs with upmost integrity and complete documentation following ALCOA principals.
Work within the stringent aseptic environment of Grade B and Grade A cleanrooms, maintaining aseptic techniques during all aspects of formulation and filling.
Adhere to gowning procedures, cleaning protocols, and environmental monitoring requirements to ensure the sterility of the product and cleanroom environment.
Monitor and verify environmental conditions (e.g., temperature, humidity, air quality) within the cleanroom to ensure they meet required specifications during filling operations.
Ensure all equipment and room has been properly cleaned and in service as required prior to use, document all cleanings accurately and contemporaneously.
Maintain accurate, detailed, and timely documentation of all formulation and filling processes in batch records, electronic systems, and logbooks.
Ensure all deviations from the standard procedures are recorded and reported immediately, and participate in the investigation and prompt resolution of deviations.
Operate and maintain key formulation and filling equipment and/or LFG’s.
Conduct regular checks and preventive maintenance on equipment to ensure they remain in optimal working condition.
Troubleshoot equipment malfunctions and escalate issues as necessary to ensure continuous production.
Perform monthly cleanings of BSCs, LFGs and incubators, along with various ad-hoc equipment cleaning.
Work closely with cross-functional teams, including Quality Assurance Shop Floor (QASF), Quality Control, Production Support and the Manufacturing Supervisor, to ensure smooth production and the highest standards of product quality.
Actively participate in training sessions for new operators and ensure knowledge sharing within the team.
Follow all safety guidelines and standard operating procedures to ensure safe handling, use and disposal of biologic materials, reagents, cleaning agents and equipment.
Participate in regular safety meetings and walkthroughs and submit “Good Saves.”
Contribute to maintaining a safety-conscious culture, and adhere to all company policies.
Report to work on time and according to the shift schedule.
Perform other duties as assigned.
Attend departmental and other scheduled meetings.
Practice good interpersonal and communication skills.
Demonstrate a positive team-oriented approach in the daily execution of procedures.
Promote and work within a team environment.
Learn new skills, procedures, and processes as assigned by management and continue to develop professionally.
Support investigation efforts as required.
Responsible for audit preparation and participation.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
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/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year