Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations

Shift Available:

Tuesday–Saturday, Onsite Afternoon Shift, 1:30 p.m. – 10:00 p.m. (start/end times may change)

• Set up and operate equipment to produce blood component lots through cell culture, harvest, and cryopreservation.
• Support deviation investigations/write-ups; support on-time closure of assigned CAPAs.
• Perform aseptic technique for tube activities (welding, connections, transfers); maintain aseptic qualification.
• Weigh and measure in-process materials to ensure proper quantities.
• Adhere to the production schedule and internal production logistics.
• Record production data/information clearly and concisely per GDPs.
• Follow safety policies, quality systems, and GMP requirements.
• Work cross-functionally as part of a team per the shift schedule; maintain training and become a SME/trainer within a designated manufacturing function.
• Perform other assigned tasks (continuous improvement, inspection readiness, right-first-time initiatives).

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing/lab technique.
• Knowledge of cGMP/FDA regulated industry; general understanding of cGMPs.
• Basic math; technical writing; proficient MS Office; understanding of biology/chemistry/medical or clinical practices.

• High School Diploma required;
  Bachelor’s/associate degree preferred.
• 0–1 years of cGMP cell therapy manufacturing/bioprocessing manufacturing or relevant experience.

• Stand for extended periods; work with contained human blood components; lift up to 25 lbs; work in labs/clean rooms with PPE and restricted-area rules.

Compensation (hourly, Summit West – NJ – US): $27.83–$33.72 per hour.