CAR-T Manufacturing Operator

Johnson & Johnson•Raritan, NJ

1d•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. We are searching for the best talent for a CAR-T Manufacturing Operator to be in Raritan, NJ. This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for the quality and maintaining the highest standards in compliance with company policies, procedures, and all applicable regulations. Responsible for fostering site pride and J&J citizenship.

Requirements

Ability to fully read and understand all standard operating procedures and work in electronic systems.
Successful Qualification and maintaining Qualification status is required for the role.
Aseptic Qualification will be required to be maintained and to avoid any scenarios that would lead to disqualification (if applicable to the role).
Advanced understanding and working knowledge of systems required per curriculum.
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, as dictated by the essential functions and responsibilities of the position.
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.
Needs to be able 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.
Knowledge of Process Excellence Tools.
Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques, and related equipment.
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.
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.
Needs direction to perform manufacturing daily tasks within functional area.
Support and contribute to projects.
Assist in troubleshooting routine manufacturing processes.
Support and execute non-routine manufacturing activities.

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.
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 our 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.
May perform other duties as assigned.

Benefits

Eligible to participate in the Company’s consolidated retirement plan (pension).
Eligible to participate in the Company’s savings plan (401(k)).
Eligible to participate in the Company’s 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.