Aseptic CAR-T Manufacturing Operator

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We are searching for the best talent for CAR-T Manufacturing Operator to be in Raritan, NJ.

Purpose: This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for the 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.

You will be responsible for:

• 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.
• In this role you would be handling Patient Blood, Viruses and Patient Cells which is contained in various containment bags/containers. As part of handling patient material, you would wear PPE (Propper Protective Equipment) and be trained in the sites Biohazard Control Plans & additional clean room trainings.
• In order to be qualified to perform Operator functions you will need to be able to fully read and understand all standard operating procedures and work in electronic systems. There will be a full qualification process through our internal training department to qualify to perform the operator’s duties. Successful Qualification and maintaining Qualification status is required for the role.
• If Applicable to the role, Aseptic Qualification will be required to be maintained and to avoid any scenarios that would lead to disqualification. Maintaining Qualification is required for the role.
• Execute manufacturing activities common to cell culturing, purification, aseptic processing, and cryopreservation, welding, sealing and using appropriate aseptic techniques.
• Responsible to record production data and information in a clear, concise, format according to Good Documentation Practices (GDP) and following ALCOA+.
• Work in a team-based (2+ Operator Process) on a specific patient batch. Collaboration in the process to execute is required.
• Support in Workshops or general process improvement programs to help aid in the development of manufacturing processes/SOPs.
• Handle human-derived materials in containment areas such as LFGIs, Containment Hoods & Biosafety Cabinets.
• Perform tasks on time in a manner consistent with quality systems and cGMP requirements.
• Flexibility with a dynamic Day to Day schedule of tasks within a standard set shift schedule.
• 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 (Grade D, C, B, A). Examples of Gowning will be a full Tyvek suit which fully encloses operator when working in a Grade A/B Space. Clean Room Scrubs, hairnet, face mask, face shield, multiple gloves for Grade C/D.
• Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.
• Operator Role requires standing for long periods of time and ability to remain in the clean room to operate on a patient batch for several hours at a time.
• Required to Punch in and out on a physical time clock daily without missing their schedule punches. All PTO to be submitted in a timely manner as outlined in our Raritan Attendance Policy.

Additional Responsibilities / Duties:

• Support the ongoing production schedule by:
• Report to work on time and according to the shift schedule (Bi-weekly rotating schedule such as Sunday-Wed/Sunday-Tuesday or Wed-Sat/Thursday-Sat)
• Attend departmental and other scheduled meetings (Shift Start Meeting, Tier Meetings, Investigations etc.)
• Practice good interpersonal and communication skills.
• Demonstrate a positive team-oriented approach in the daily execution of procedures.
• Promote and work within a team environment
• Learn new skills, procedures, and process 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.

Key Competencies/Skills/Requirements:

COMPUTER ABILITY:

• Advanced 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.)

MATHEMATICAL SKILLS: Add, subtract, multiply and divide into all units of measure, using whole numbers, common fractions, and decimals.

LANGUAGE SKILLS:

• English is Required (All systems are in English)
• Read and interpret documents such as safety rules, operating instructions, and logbooks
• Read and understand English written SOP and Batch Records.

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, stoop; and reach with hands and arms.
• Ability to lift 25 lbs.
• Needs to be able to perform gowning procedures to work in the clean room.
• Ability to use small instruments such as micropipettes and be able to pick up and place down small vials into vial racks
• Ability to be in the clean room for up to 5-6 hours at a time without need to gown out
• Ability to stand for long period of time

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.

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.

Qualifications / Requirements:

EDUCATION AND EXPERIENCE:

• HS Diploma required with 4-6 Years of Biotech/Pharmaceutical experience or equivalent industry experience
• Associate degree required with 2-4 Years of Biotech/Pharmaceutical experience or equivalent industry experience.
• Bachelor’s degree required in Life Sciences or Engineering, with 0-2 years of Biotech/Pharmaceutical experience or equivalent industry experience

Scope of responsibilities:

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.

Additional Information:

The anticipated base pay range for this position is $49,000 to $68,000 per year.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be 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.
• Employees are eligible for the following time off benefits:
  • Vacation – up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below.
  

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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 and 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 email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most diversified healthcare products company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 150,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.