CAR-T Aseptic 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.

• 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.
• Centrifuge, Serological pipettes, repeater pipettes, sealers, Visual Inspection, Met One particle counter, MAS
  100 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.

• 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.

• 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 E  and SOPs with upmost integrity and complete documentation following ALCOA principals.

• Work within the stringent aseptic environment of Grade B and Grade A clean rooms, 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…