Sr. Cell Processing Operator CAR-T

Johnson & Johnson Innovative Medicine • Raritan, NJ

1d • Onsite

About The Position

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. 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.

Requirements

• High School diploma required with a minimum of 4 years of work experience in Biotech, Pharmaceutical, or equivalent regulated manufacturing industry OR Bachelor’s degree in Life Sciences or Engineering with 0–2 years of Biotech/Pharmaceutical or equivalent industry experience
• 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
• 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
• Ability to perform basic mathematical calculations, including addition, subtraction, multiplication, and division using whole numbers, fractions, and decimals
• Knowledge of and ability to operate manufacturing, manufacturing‑support, and laboratory equipment
• Familiarity with Process Excellence and continuous improvement tools
• Solid understanding of routine and non‑routine testing and sampling methods, including associated techniques and equipment
• Be mobile and able to independently travel between work areas or locations as required by job responsibilities
• Frequently communicate with coworkers and cross‑functional 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

Nice To Haves

• Accountability
• Agile Manufacturing
• Analytics Dashboards
• Chemistry, Manufacturing, and Control (CMC)
• Communication
• Data Compilation
• Data Savvy
• Gap Analysis
• Good Manufacturing Practices (GMP)
• Industry Analysis
• Operational Excellence
• Pharmaceutical Industry
• Plant Operations
• Process Optimization
• Process Oriented
• Project Administration
• Regulatory Compliance

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 team‑based, cross‑functional 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.
• 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, team‑oriented 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

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED