CAR T MOI QCCB Operator

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

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 are searching for the best talent for CAR T MOI QCCB Operator to be in Raritan NJ.

Purpose: 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.

You will be responsible for:

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.

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 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.

AUTONOMY and COMPLEXITY:

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.

NATURE OF TASKS:

Manufacturing Operator

Basic technical knowledge within functional units

Demonstrate a basic understanding of the process to perform the assigned manufacturing tasks properly.

Computer 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.

Qualifications / Requirements:

EDUCATION AND EXPERIENCE:

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

Bachelors degree required in Life Sciences or Engineering with 0-2 years of Biotech/Pharmaceutical experience or equivalent industry experience.

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 into all units of measure using whole numbers common fractions 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 stoop; and reach with hands and arms.
• Ability to lift 25 lbs.
• Needs to perform gowning procedures to work in the manufacturing core.

*The Raritan CAR-T Manufacturing organization is committed to working with any applicant or employee to make reasonable accommodations in the job structure in consideration of any known physical challenges or disabilities.

Additional Information:

The anticipated base pay range for this position is $49000 to $68000.

The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance.
• Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Companys long-term incentive program.
• Employees are eligible for the following time off benefits:
  • Vacation up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year
  • Holiday pay including Floating Holidays up to 13 days per calendar year of Work Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

  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 and 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 please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

  The anticipated base pay range for this position is :

  The anticipated base pay range for this position is $49000 to $68000.

  Additional Description for Pay Transparency:

  The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Employees are eligible for the following time off benefits: Vacation up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year Holiday pay including Floating Holidays up to 13 days per calendar year of Work Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.