MOI/QCCB Lead Operator

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 jnj.com

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.

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Assembly

Job Category:

Business Enablement/Support

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Job Description

About Innovative Medicine

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.

Learn more at

POSITION SUMMARY :

MOI/QCCB LEAD - Monday – Friday 08:00 AM -04:30PM

This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Responsible for fostering site pride and J&J citizenship.

ESSENTIAL FUNCTIONS :

• Be part of the manufacturing operations team responsible for Multiplicity of Infection (MOI), Quality Control Cell Bank preparation of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
• Lead and Independently execute MOI & QCCB CAR-T manufacturing and support processes according to standard operating procedures and current curriculum.
• Execute manufacturing activities common to 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 in a manner 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 as well as input of team members.
• Handle human derived materials in containment areas.
• Support schedule adjustments to meet production.
• Accurately complete documentation in SOP’s, logbooks and other GMP documents.
• Demonstrate training progression through 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 working 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.

ADDITIONAL RESPONSIBILITIES/DUTIES :

• Support the ongoing production schedule by:
• 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 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.

AUTONOMY and COMPLEXITY :

• Needs direction to perform manufacturing daily tasks within functional area.
• Support and contributes to projects
• Assist in troubleshooting routine manufacturing processes
• Support and execute non-routine manufacturing activities.

Manufacturing Operator

• Basic technical knowledge within functional units
• Demonstrate a basic understanding of the process to properly perform the assigned manufacturing tasks.

TECHNICAL ABILITY:

• Basic 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

EDUCATION AND EXPERIENCE:

• HS Diploma required with 6 Years Biotech/Pharmaceutical experience or equivalent industry experience is required.
• Bachelor’s degree required in Life Sciences or Engineering, with 2 years Biotech/Pharmaceutical experience or equivalent industry experience preferred.

LANGUAGE SKILLS :

• Read and interpret documents such as safety rules, operating instructions, and logbooks
• Review and provide feedback for SOP and Batch Record Revisions

REASONING ABILITY :

• 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.

MATHEMATICAL SKILLS :

• Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals.

OTHER SKILLS, ABILITIES OR QUALIFICATIONS :

• 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.

PHYSICAL DEMANDS :

While performing the duties of this job, the employee:

• 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, and stoop; and reach with hands and arms.
• Ability to lift 25 lbs.
• Needs to perform gowning procedures to work in manufacturing core.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

IMPORTANT This position description is a general guideline for colleagues; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling, or other business needs.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

63000-96000

Additional Description for Pay Transparency:

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 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below.