Cryopreservation Mfg Operator, CAR-T

Johnson & Johnson Innovative Medicine; Raritan (NJ); On-site; USD 43,000 - 70,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking a Cryopreservation Manufacturing Operator for autologous CAR-T production in a CGMP cleanroom. You will perform manufacturing tasks, maintain quality, and ensure documentation compliance in a team-driven environment.

The role requires attention to GMP standards, the ability to handle human-derived materials, and adherence to safety procedures with specific shift times.

Qualifications

• High School Diploma or equivalent with biotech/pharma experience preferred.
• Bachelor’s in Life Sciences or Engineering with 0–2 years biotech/pharma experience accepted.

Responsibilities

• Manufacture cryopreservation autologous CAR-T products in a CGMP cleanroom.
• Execute manufacturing-support processes per SOPs and batch records.
• Record production data clearly per GDP and maintain compliance.

Skills

GMP knowledge

MSAT

Process Excellence Tools

Data entry

Education

High School Diploma

Bachelor's degree in Life Sciences/Engineering

Tools

SAP

EBR

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Assembly

Job Category:

Business Enablement/Support

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

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.

Learn more at https://www.jnj.com/innovative-medicine

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:

Qualifications:

EDUCATION AND EXPERIENCE –

• 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 Saturday either 1st Shift (8AM to 4:30 PM) or 2nd Shift (2:30 PM to 10:30 PM)

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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#LI-Onsite

Required Skills:

Preferred Skills:

Administrative Support, Agile Manufacturing, Assembly Operations, Communication, Execution Focus, Factory Acceptance Test (FAT), Good Manufacturing Practices (GMP), Innovation, Learning Agility, Manufacturing Processes, Manufacturing Science and Technology (MSAT), Mechanical Equipments, Plant Operations, Process Oriented, Prototyping, Repair Management, Structural Fabrication, Technologically Savvy

The anticipated base pay range for this position is :

$43,050.00 - $70,035.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits