Cryopreservation Mfg Operator, CAR-T

Cryopreservation Manufacturing Operator, CAR T

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.

We are searching for the best talent for a Cryopreservation Manufacturing Operator, CAR T.

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.

Key Responsibilities:

• Be part of the manufacturing operations team responsible for Cryopreservation, 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 Cryopreservation or manufacturing-support processes according to standard operating procedures and current curriculum.
• Execute manufacturing activities every day 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:

• Support the ongoing production schedule by:
• Reporting to work on-time and according to the shift schedule.
• Performing other duties as assigned.
• Attending departmental and other scheduled meetings.
• Practicing good interpersonal and communication skills.
• Demonstrating positive team-oriented approach in the daily execution of procedures.
• Promoting work within a team environment.
• Learning new skills, procedures and processes as assigned by management and continue to develop professionally.
• Supporting investigation efforts as required.
• Being responsible for audit preparation and participation.

Qualifications:

• High School Diploma required with 4 Years Biotech or Pharmaceutical experience or equivalent industry experience.
• OR
• Bachelor's degree required in Life Sciences or Engineering with 0- 2 years Biotech or Pharmaceutical experience or equivalent industry experience.

Nature of Tasks:

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

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.

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.

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.
• Amenable to working from Tuesday to Friday either 1st Shift (8AM to 4:30 PM) or 2nd Shift (2:00 PM to 10:30 PM)