CAR-T Manufacturing Operator

Johnson & Johnson Innovative Medicine•Raritan, NJ

1d•Onsite

About The Position

At Johnson & Johnson, health is everything. The company leverages its strength in healthcare innovation to prevent, treat, and cure complex diseases, develop smarter and less invasive treatments, and provide personal solutions. Through expertise in Innovative Medicine and MedTech, Johnson & Johnson aims to innovate across the full spectrum of healthcare solutions to deliver future breakthroughs and profoundly impact health for humanity. The company is committed to its employees, providing an inclusive work environment that respects diversity and recognizes merit. The Innovative Medicine sector is inspired by patient insights, fueling science-based advancements to develop life-saving medicines. This position is for a CAR-T Manufacturing Operator in Raritan, NJ, responsible for performing manufacturing procedures and executing scheduled tasks within a CGMP environment. The role emphasizes quality and adherence to the highest standards in compliance with company policies, procedures, and all applicable regulations, while fostering site pride and J&J citizenship.

Requirements

High School Diploma required with 4-6 Years of Biotech/Pharmaceutical experience or equivalent industry experience OR Associate's 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.
Ability to utilize 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.
English language proficiency is required (all systems are in English).
Ability to read and interpret documents such as safety rules, operating instructions, and logbooks.
Ability to read and understand English written SOP and Batch Records.
Needs to be mobile and able to independently transport themselves between various sites/locations.
Is frequently required to communicate with coworkers.
Regularly required to stand; walk; climb, bend, stoop; and reach with hands and arms.
Ability to lift 25 lbs.
Ability to perform gowning procedures to work in the clean room.
Ability to use small instruments such as micropipettes and be able to pick up and place down small vials into vial racks.
Ability to be in the clean room for up to 5-6 hours at a time without need to gown out.
Ability to stand for long period of time.
Amenable to working from Wednesday to Saturday either 1st Shift (6:00 AM to 7:00 PM) or 2nd Shift (1:00 PM to 1:00 AM).
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.
Knowledge and ability to operate manufacturing, manufacturing-support, and lab equipment.
Basic technical knowledge within functional units.
Demonstrate a basic understanding of the process to properly perform the assigned manufacturing tasks.
Needs direction to perform manufacturing daily tasks within functional area.
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

Administrative Support
Agile Manufacturing
Assembly Operations
Communication
Execution Focus
Factory Acceptance Test (FAT)
Good Manufacturing Practices (GMP)
Innovation
Learning Agility
Manufacturing Processes
Manufacturing Science and Technology (MSAT)
Mechanical Equipments
Plant Operations
Process Oriented
Prototyping
Repair Management
Structural Fabrication
Technologically Savvy

Responsibilities

Be part of the manufacturing operations team responsible for the production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
Handle Patient Blood, Viruses and Patient Cells which is contained in various containment bags/containers.
Wear PPE (Propper Protective Equipment) and be trained in the sites Biohazard Control Plans & additional clean room trainings.
Fully read and understand all standard operating procedures and work in electronic systems.
Maintain Aseptic Qualification (if applicable to the role).
Execute manufacturing activities common to cell culturing, purification, aseptic processing, and cryopreservation, welding, sealing and using appropriate aseptic techniques.
Record production data and information in a clear, concise, format according to Good Documentation Practices (GDP) and following ALCOA+.
Work in a team-based (2+ Operator Process) on a specific patient batch.
Collaborate in the process to execute.
Support in Workshops or general process improvement programs to help aid in the development of manufacturing processes/SOPs.
Handle human-derived materials in containment areas such as LFGIs, Containment Hoods & Biosafety Cabinets.
Perform tasks on time in a manner consistent with quality systems and cGMP requirements.
Maintain flexibility with a dynamic Day to Day schedule of tasks within a standard set shift schedule.
Accurately complete documentation in SOP’s, logbooks, and other GMP documents.
Demonstrate training progression through the assigned curriculum.
Maintain a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations.
Wear the appropriate PPE when working in manufacturing and other hazardous working environments (Grade D, C, B, A).
Proactively maintain a clean and safe work environment.
Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.
Punch in and out on a physical time clock daily without missing their schedule punches.
Submit all PTO in a timely manner as outlined in the Raritan Attendance Policy.
Report to work on time and according to the shift schedule (bi-weekly rotating schedule such as Sunday-Wed/Sunday-Tuesday or Wed-Sat/Thursday-Sat).
Attend departmental and other scheduled meetings (Shift Start Meeting, Tier Meetings, Investigations etc.).
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 process as assigned by management and continue to develop professionally.
Support investigation efforts as required.
Be responsible for audit preparation and participation.
Perform other duties as assigned.

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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year