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

Position Title

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

Value Stream CAR-T Manufacturing Operations

Summit West, NJ (US) - S12

Join our team manufacturing human blood-derived components for CAR-T therapies in a controlled, cGMP cleanroom environment. You ll work under the supervision of Manufacturing Management, strictly adhering to regulatory requirements and Standard Operating Procedures (SOPs). Job duties are performed within a team and according to an assigned production shift schedule. Production deviations must be communicated and you will assist with quality investigations as needed.

• Day Shifts (Quad 1 or Quad
  3): 5:00 AM – 5:30 PM, Sunday-Wednesday or Wednesday-Saturday
• Night Shifts (Quad 2 or Quad
  4): 5:00 PM – 5:30 AM, Sunday-Wednesday or Wednesday-Saturday
• Start and end times may change based on business needs.

• Set up and operate equipment supporting production of blood component lots through cell culture, harvest, and cryopreservation
• Apply aseptic technique for tube welding, connections, and transfers; aseptic qualification required
• Weigh and measure in-process materials to ensure proper quantities
• Adhere to production schedule for on-time, internal logistics
• Record production data and information clearly, concisely, and according to GDPs
• Support deviation investigations and related write-ups; ensure timely closure of assigned CAPAs
• Perform all tasks in accordance with site safety policies, quality systems, and GMP requirements
• Collaborate in a team-based, cross-functional environment to complete production tasks for the assigned shift
• Maintain on-time completion of training assignments to sustain necessary technical skills and process knowledge
• May become a Subject Matter Expert (SME) and qualified trainer within designated manufacturing functions
• Perform additional duties as assigned, including continuous improvement projects, inspection readiness, and right-first-time initiatives

Reports to the Manufacturing Manager. Supervision managed by Shift Supervisor or designated Team Lead.

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
• Knowledge of cGMP/FDA-regulated industry
• Basic mathematical skills; general understanding of cGMPs
• Technical writing capability
• Proficiency in MS Office applications
• Background in biology, chemistry, medical, or clinical practices
• Prior experience in manufacturing and/or scientific/engineering education preferred

• Bachelor's degree
• Associate/Medical Technical degree and 3 years of manufacturing operations experience
• High School diploma/GED and 2 years of manufacturing or operations experience

• Intermittent walking and sitting; ability to sit or stand for extended periods may be required
• Comfortable working with contained human blood components
• Physical dexterity to use computers and documentation
• Sufficient vision and hearing to work in environment
• Ability to lift up to 25 pounds
• Work in laboratories and controlled, enclosed, restricted areas
• Cleanroom garments and PPE required in designated areas
• No makeup, gum, nail polish, or other microbial sources allowed in restricted areas
• Flexibility to don cleanroom garments and PPE
• Cleanroom is an enclosed, restricted space with assigned pressure and temperature conditions
• Exposure to reagents, chemicals, sanitization agents, and routine exposure to human blood components
• Potential exposure to strong magnets
• Designated areas may prohibit food and outside materials (e.g., cell phones, tablets)

• The primary duties and responsibilities described are essential functions for this role, though other incidental or secondary duties may be assigned.
• Employees must perform any other job-related duties as requested by management.

If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Summit West - NJ - US $27.83 - $33.72 per…