Operator

CAR-T Manufacturing Operator

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

General:

• 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.

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:

• 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:

• 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:

• In-depth knowledge of aseptic techniques, GMP standards, and the formulation and filling processes for biologic products and/or within a glovebox.