Aseptic Manufacturing Operator CAR-T
J&J Family of Companies, Raritan, NJ, United States
CAR-T Manufacturing Operator
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 CAR-T Manufacturing Operator to be in Raritan, NJ.
The CAR-T Aseptic Manufacturing Operator is responsible for the formulation and filling of final cell therapy products or preparation of components used for cell therapy products within a GMP-compliant cleanroom environment. Working in Grade C, Grade B and Grade A cleanroom environments, the operator will focus on the preparation and aseptic filling of an autologous CAR-T product and associated components for patient material, ensuring that all steps are performed with precision to maintain product integrity. The role requires a high level of expertise in aseptic techniques, attention to detail, and strict adherence to GMP and regulatory requirements to produce a safe and effective cell therapy.
Duties / Responsibilities
Follow Grade B gowning requirements (PPE requiring coveralls, bouffant, boots, etc.), while completing gown (re)qualification on an annual basis.
Aseptic processing within a (Grade A) Biosafety Cabinet or Laminar Flow Glovebox - open process with human derived materials where maintaining complete sterility is of the utmost importance.
Supporting non-Commercial Operations activities such as Media Fills, Aseptic Process Simulations, Environmental Monitoring Process Qualifications etc. in Grade B or Grade C environment.
Extended initial training period where all requirements must be successfully met; Aseptic Process requalification every 6-months.
Deft hand-manipulation technique / hand-eye coordination / ability to lift 2L bags
Adaptability to change in real-time and remain composed under pressure; flexibility in schedule due to variability in the product (patient material / process).
Meeting strict time constraints
knowing how to prioritize required activities while still maintaining aseptic conditions.
Performing daily comprehensive environmental monitoring (EM) plating using agar plates, while maintaining minimal Action and Alert Limit EM excursions.
Partnering with QA Micro and QASF in support of performing daily / weekly oversight checks to ensure practices are upheld.
Notable equipment proficiencies:
Centrifuge, Serological pipettes, repeater pipettes, sealers, Visual Inspection, MetOne particle counter, MAS100 air sampler, tube welders
Formulation of Final Product:
Prepare final formulation for a cell therapy product in compliance with prescribed protocols and GMP standards.
Perform aseptic formulation procedures, including the preparation of buffer solutions, cryoprotectants, and other key reagents, ensuring proper mix and concentration.
Ensure that the final product meets all specifications for viability, sterility, and quality before it enters the filling process.
Filling:
Perform aseptic filling of a cell therapy product into vials, bags, or other containers, ensuring no contamination or loss of product integrity.
Ensure all filling activities are performed according to SOPs and in compliance with Grade A cleanroom conditions.
Operate filling equipment, such as manual devices, ensuring proper operation and calibration.
Perform visual inspections of filled products to confirm proper fill volume, container integrity, and labeling accuracy.
Complete and review batch records and associated documentation for all formulation and filling activities.
Laminar Flow Gloveboxes:
Perform aseptic manipulations within a laminar flow glovebox (LFG) consisting of vials, bags, or other containers, ensuring no contamination or loss of product integrity.
Operate comfortably working with lentivirus in a BSL2+ environment.
Inspect all materials for high quality and sterility before, during and after processes.
Follow EBR and SOPs with upmost integrity and complete documentation following ALCOA principals.
Cleanroom Compliance:
Work within the stringent aseptic environment of Grade B and Grade A cleanrooms, maintaining aseptic techniques during all aspects of formulation and filling.
Adhere to gowning procedures, cleaning protocols, and environmental monitoring requirements to ensure the sterility of the product and cleanroom environment.
Monitor and verify environmental conditions (e.g., temperature, humidity, air quality) within the cleanroom to ensure they meet required specifications during filling operations.
Ensure all equipment and room has been properly cleaned and in service as required prior to use, document all cleanings accurately and contemporaneously.
Quality Control and Documentation:
Maintain accurate, detailed, and timely documentation of all formulation and filling processes in batch records, electronic systems, and logbooks.
Ensure all deviations from the standard procedures are recorded and reported immediately, and participate in the investigation and prompt resolution of deviations.
Equipment and Operation and Maintenance:
Operate and maintain key formulation and filling equipment and/or LFG's.
Conduct regular checks and preventive maintenance on equipment to ensure they remain in optimal working condition.
Troubleshoot equipment malfunctions and escalate issues as necessary to ensure continuous production.
Performing monthly cleanings of BSCs, LFGs and incubators, along with various ad-hoc equipment cleaning.
Collaboration and Communication:
Work closely with cross-functional teams, including Quality Assurance Shop Floor (QASF), Quality Control, Production Support and the Manufacturing Supervisor, to ensure smooth production and the highest standards of product quality.
Actively participate in training sessions for new operators and ensure knowledge sharing within the team.
Safety and Compliance:
Follow all safety guidelines and standard operating procedures to ensure safe handling, use and disposal of biologic materials, reagents, cleaning agents and equipment.
Participate in regular safety meetings and walkthroughs and submit "Good Saves." Contribute to maintaining a safety-conscious culture,and adhere to all company policies.
Additional Responsibilities / Duties:
Support the ongoing production schedule by:
Report to work on time and according to the shift schedule.
Perform other duties as assigned.
Attend departmental and other scheduled meetings.
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 processes 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:
Read and interpret documents such as safety rules, operating instructions, and logbooks
Review and provide feedback for SOP and Batch Record Revisions
PHYSICAL DEMANDS:
While performing the duties of this job, the employee:
Ability to work in a cleanroom environment, wearing appropriate (comprehensive) personal protective equipment (PPE), while regularly standing for extended periods of time.
Strong manual dexterity and ability to perform repetitive tasks with precision and accuracy.
Standing for extended periods of time in comprehensive gowning.
Ability to lift 2L bags.
REASONING ABILITY:
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 CAR-T Manufacturing Operator to be in Raritan, NJ.
The CAR-T Aseptic Manufacturing Operator is responsible for the formulation and filling of final cell therapy products or preparation of components used for cell therapy products within a GMP-compliant cleanroom environment. Working in Grade C, Grade B and Grade A cleanroom environments, the operator will focus on the preparation and aseptic filling of an autologous CAR-T product and associated components for patient material, ensuring that all steps are performed with precision to maintain product integrity. The role requires a high level of expertise in aseptic techniques, attention to detail, and strict adherence to GMP and regulatory requirements to produce a safe and effective cell therapy.
Duties / Responsibilities
Follow Grade B gowning requirements (PPE requiring coveralls, bouffant, boots, etc.), while completing gown (re)qualification on an annual basis.
Aseptic processing within a (Grade A) Biosafety Cabinet or Laminar Flow Glovebox - open process with human derived materials where maintaining complete sterility is of the utmost importance.
Supporting non-Commercial Operations activities such as Media Fills, Aseptic Process Simulations, Environmental Monitoring Process Qualifications etc. in Grade B or Grade C environment.
Extended initial training period where all requirements must be successfully met; Aseptic Process requalification every 6-months.
Deft hand-manipulation technique / hand-eye coordination / ability to lift 2L bags
Adaptability to change in real-time and remain composed under pressure; flexibility in schedule due to variability in the product (patient material / process).
Meeting strict time constraints
knowing how to prioritize required activities while still maintaining aseptic conditions.
Performing daily comprehensive environmental monitoring (EM) plating using agar plates, while maintaining minimal Action and Alert Limit EM excursions.
Partnering with QA Micro and QASF in support of performing daily / weekly oversight checks to ensure practices are upheld.
Notable equipment proficiencies:
Centrifuge, Serological pipettes, repeater pipettes, sealers, Visual Inspection, MetOne particle counter, MAS100 air sampler, tube welders
Formulation of Final Product:
Prepare final formulation for a cell therapy product in compliance with prescribed protocols and GMP standards.
Perform aseptic formulation procedures, including the preparation of buffer solutions, cryoprotectants, and other key reagents, ensuring proper mix and concentration.
Ensure that the final product meets all specifications for viability, sterility, and quality before it enters the filling process.
Filling:
Perform aseptic filling of a cell therapy product into vials, bags, or other containers, ensuring no contamination or loss of product integrity.
Ensure all filling activities are performed according to SOPs and in compliance with Grade A cleanroom conditions.
Operate filling equipment, such as manual devices, ensuring proper operation and calibration.
Perform visual inspections of filled products to confirm proper fill volume, container integrity, and labeling accuracy.
Complete and review batch records and associated documentation for all formulation and filling activities.
Laminar Flow Gloveboxes:
Perform aseptic manipulations within a laminar flow glovebox (LFG) consisting of vials, bags, or other containers, ensuring no contamination or loss of product integrity.
Operate comfortably working with lentivirus in a BSL2+ environment.
Inspect all materials for high quality and sterility before, during and after processes.
Follow EBR and SOPs with upmost integrity and complete documentation following ALCOA principals.
Cleanroom Compliance:
Work within the stringent aseptic environment of Grade B and Grade A cleanrooms, maintaining aseptic techniques during all aspects of formulation and filling.
Adhere to gowning procedures, cleaning protocols, and environmental monitoring requirements to ensure the sterility of the product and cleanroom environment.
Monitor and verify environmental conditions (e.g., temperature, humidity, air quality) within the cleanroom to ensure they meet required specifications during filling operations.
Ensure all equipment and room has been properly cleaned and in service as required prior to use, document all cleanings accurately and contemporaneously.
Quality Control and Documentation:
Maintain accurate, detailed, and timely documentation of all formulation and filling processes in batch records, electronic systems, and logbooks.
Ensure all deviations from the standard procedures are recorded and reported immediately, and participate in the investigation and prompt resolution of deviations.
Equipment and Operation and Maintenance:
Operate and maintain key formulation and filling equipment and/or LFG's.
Conduct regular checks and preventive maintenance on equipment to ensure they remain in optimal working condition.
Troubleshoot equipment malfunctions and escalate issues as necessary to ensure continuous production.
Performing monthly cleanings of BSCs, LFGs and incubators, along with various ad-hoc equipment cleaning.
Collaboration and Communication:
Work closely with cross-functional teams, including Quality Assurance Shop Floor (QASF), Quality Control, Production Support and the Manufacturing Supervisor, to ensure smooth production and the highest standards of product quality.
Actively participate in training sessions for new operators and ensure knowledge sharing within the team.
Safety and Compliance:
Follow all safety guidelines and standard operating procedures to ensure safe handling, use and disposal of biologic materials, reagents, cleaning agents and equipment.
Participate in regular safety meetings and walkthroughs and submit "Good Saves." Contribute to maintaining a safety-conscious culture,and adhere to all company policies.
Additional Responsibilities / Duties:
Support the ongoing production schedule by:
Report to work on time and according to the shift schedule.
Perform other duties as assigned.
Attend departmental and other scheduled meetings.
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 processes 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:
Read and interpret documents such as safety rules, operating instructions, and logbooks
Review and provide feedback for SOP and Batch Record Revisions
PHYSICAL DEMANDS:
While performing the duties of this job, the employee:
Ability to work in a cleanroom environment, wearing appropriate (comprehensive) personal protective equipment (PPE), while regularly standing for extended periods of time.
Strong manual dexterity and ability to perform repetitive tasks with precision and accuracy.
Standing for extended periods of time in comprehensive gowning.
Ability to lift 2L bags.
REASONING ABILITY: