Cryopreservation Mfg Operator, Car-t

Johnson & Johnson Johnson & Johnson · Pharma · Raritan, NJ +1

This role is responsible for performing manufacturing procedures and executing scheduled tasks within a CGMP environment for the cryopreservation, clinical and commercial preparation of autologous CAR-T products. It involves cell culturing, purification, aseptic processing, and cryopreservation.

What you'd actually do

  1. 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.
  2. Independently execute Cryopreservation or manufacturing-support processes according to standard operating procedures and current curriculum.
  3. Execute manufacturing activities every day for cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.
  4. 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).
  5. Perform tasks on time consistent with quality systems and cGMP requirements.

Skills

Required

  • High School Diploma or Bachelor's degree in Life Sciences or Engineering
  • Experience in Biotech or Pharmaceutical industry
  • Understanding of manufacturing tasks
  • Basic technical knowledge within functional units
  • Ability to follow standard operating procedures
  • Good Documentation Practices (GDP)
  • Ability to work in a team-based, cross-functional environment
  • Ability to handle human-derived materials in containment areas
  • Ability to maintain a clean and safe work environment
  • Basic cGMP requirements knowledge

Nice to have

  • Aid in the development of manufacturing processes
  • Drive continuous improvement of manufacturing operations
  • Support schedule adjustments to meet production
  • Support investigation efforts

What the JD emphasized

  • cGMP