CAR T MOI QCB Operator

Johnson & Johnson Innovative Medicine•Raritan, NJ

19h•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. Learn more at https://www.jnj.com/innovative-medicine 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. Learn more at https://www.jnj.com/. We are searching for the best talent for a CAR T MOI QCCB Operator to be in Raritan, NJ. This position is responsible for performing manufacturing procedures and executing scheduled tasks within a CGMP environment. This position is responsible for 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

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.
Read and interpret documents such as safety rules, operating instructions, and logbooks
Review and provide feedback for SOP and Batch Record Revisions
Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Follow instructions
Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Add, subtract, multiply and divide into all units of measure, using whole numbers, common fractions, and decimals.
Knowledge and ability to operate manufacturing, manufacturing-support, and lab equipment.
Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques, and related equipment.
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.
While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend, stoop; and reach with hands and arms.
Ability to lift 25 lbs.
Needs to perform gowning procedures to work in the manufacturing core.
The selected candidate will have to be amenable to a day shift schedule - Monday to Friday - 8:00 to 4:30 PM

Nice To Haves

Knowledge of Process Excellence Tools

Responsibilities

Be part of the manufacturing operations team responsible for MOI/QCCB, clinical and commercial preparation of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
Independently execute MOI/QCCB or manufacturing-support processes according to standard operating procedures and current curriculum.
Execute daily manufacturing activities for cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.
Perform process unit operations according to standard operating procedures and batch records, and record production data and information in a clear, concise format according to Good Documentation Practices (GDP).
Perform tasks on time consistent with quality systems and cGMP requirements.
Work in a team-based, cross-functional environment to complete production tasks required by shift schedule.
Aid in the development of manufacturing processes, including appropriate documentation.
Drive continuous improvement of manufacturing operations leveraging own observation and input of team members.
Handle human-derived materials in containment areas.
Support schedule adjustments to meet production.
Accurately complete documentation in SOPs, logbooks, and other GMP documents.
Demonstrate training progression through the assigned curriculum.
Accountable for maintaining 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 environments.
Proactively maintain a clean and safe work environment.
Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors
Ensure materials are available for production.
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.
Available for overtime as needed.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits