Car-t Manufacturing Operator

3 weeks ago

Raritan, United States Johnson & Johnson Full time

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Manufacturing Operator located in Raritan, NJ. #CART

:
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.

**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.

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 t

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