Sr. Cell Processing Operator CAR-T

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Learn more at internal pre-identified candidate for consideration has been identified. However all applications will be considered.

We are searching for the best talent for a Sr. Cell Processing 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:

• Participate as a member 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 and manufacturing-support activities in accordance with approved standard operating procedures (SOPs) and required training curriculum.
• Perform daily manufacturing activities including cell culturing purification aseptic processing and cryopreservation using appropriate techniques.
• Execute process unit operations following SOPs and batch records and accurately recording production data in compliance with Good Documentation Practices (GDP).
• Complete manufacturing tasks in a timely manner while adhering to quality systems and cGMP requirements.
• Collaborate within a teambased crossfunctional environment to meet production objectives aligned with shift schedules.
• Support the development and enhancement of manufacturing processes including preparation and maintenance of associated documentation.
• Drive continuous improvement initiatives through personal observations and team input.
• Safely handle human-derived materials within designated containment areas.
• Support schedule adjustments to meet production.
• Accurately complete documentation in SOPs logbooks and other GMP documents.
• Maintain a working knowledge of cGMP principles to ensure compliance with regulatory requirements and internal policies.
• 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 organized and safe work environment; identify address and communicate safety hazards or unsafe behaviors.
• Ensure required materials and supplies are available and prepared to support uninterrupted production activities.

Additional Responsibilities:

• Support the ongoing production schedule by:
• Maintaining reliable attendance and reporting to work on time in accordance with assigned shift schedules
• Completing additional tasks and responsibilities as assigned
• Attending departmental and other scheduled meetings as required
• Demonstrating effective interpersonal and communication skills
• Maintaining a positive teamoriented approach while executing daily procedures
• Actively supporting and contributing to a collaborative team environment
• Learning new skills procedures and processes as directed by management and pursuing ongoing professional development
• Assisting with investigation activities as needed
• Supporting audit preparation efforts and participating in audits as required

Autonomy and Complexity:

• Performs daily manufacturing tasks within the assigned functional area under routine guidance and supervision
• Supports and contributes to projectbased activities as directed
• Assists with troubleshooting and resolving routine manufacturing issues
• Supports and executes nonroutine manufacturing activities following established procedures

Nature of Tasks

• Functions as a Manufacturing Operator
• Applies basic technical knowledge within assigned functional unit(s)
• Demonstrates a foundational understanding of manufacturing processes to properly and consistently perform assigned tasks

Computer Ability

• Possesses a basic working knowledge of required systems as defined by the training curriculum
• Utilizes Microsoft Office tools and other business systems to support operational effectiveness
• Demonstrates accurate and consistent data entry skills in manufacturing applications including SAP electronic batch records (EBR) and related systems

Qualifications / Requirements:

Education and Experience

• High School diploma required with a minimum of 4 years of work experience in Biotech Pharmaceutical or equivalent regulated manufacturing industry
  OR
• Bachelors degree in Life Sciences or Engineering with 02 years of Biotech/Pharmaceutical or equivalent industry experience

Language Skills

• Ability to read understand and follow safety rules operating instructions SOPs and logbooks
• Capable of reviewing and providing feedback on SOP and Batch Record revisions

Reasoning Ability

• Ability to interpret and follow instructions provided in written verbal diagrammatic or scheduled formats
• Capable of solving practical routine problems and managing multiple variables in environments with limited standardization
• Consistently follows established procedures and work instructions

Mathematical Skills

• Ability to perform basic mathematical calculations including addition subtraction multiplication and division using whole numbers fractions and decimals

Other Skills Abilities and Qualifications

• Knowledge of and ability to operate manufacturing manufacturingsupport and laboratory equipment
• Familiarity with Process Excellence and continuous improvement tools
• Solid understanding of routine and nonroutine testing and sampling methods including associated techniques and equipment

Physical Demands

• While performing the duties of this position the employee must:
• Be mobile and able to independently travel between work areas or locations as required by job responsibilities
• Frequently communicate with coworkers and crossfunctional team members
• Regularly stand walk climb bend stoop and reach with hands and arms
• Be capable of lifting up to 25 pounds
• Perform gowning procedures required for work in the manufacturing core and controlled environments

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 please contact us via or contact AskGS to be directed to your accommodation resource.

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