CAR-T Manufacturing Operator

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 with 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 the production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.

• Independently execute manufacturing or manufacturing-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).

• 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 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 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.

• Perform tasks on time in a manner consistent with quality systems and cGMP requirements.

ADDITIONAL RESPONSIBILITIES/DUTIES:

• Support the ongoing production schedule by:

O Report to work on time and according to the shift schedule.

O Perform other duties as assigned.

O Attend departmental and other scheduled meetings.

O Practice good interpersonal and communication skills.

O Demonstrate a positive team-oriented approach in the daily execution of procedures.

O Promote and work within a team environment.

O 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.

This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.

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.

Are you interested in joining a team that is positively impacting patient's lives through cutting edge cell therapy? Apply today to be part of the #CAR-T team!

Qualifications

NATURE OF TASKS:

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

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.)

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

Bachelor's 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 $49,088 to $66,413 annually.
• This position is overtime eligible
• Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal, and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.