Manufacturing Associate, CAR - T

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Job Title: Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations
Department: Value Stream CAR-T Manufacturing Operations
Location: US-NJ-Summit West, S12

Position Summary:
The Manufacturing Associate is responsible for manufacturing human blood-derived components according to Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Associates adhere to regulatory requirements and perform duties within a team, following a production shift schedule. Communicating production deviations and assisting with quality investigations are part of the role. Day and night shift structures are available, with schedules subject to change based on business demands.

Key Duties and Responsibilities:

• Set up and operate equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
• Support deviation investigations and documentation as needed; assist with on-time closure of assigned CAPAs within the designated shift.
• Perform aseptic technique for tube activities, including welding, connections, and transfers; aseptic qualification required.
• Weigh and measure in-process materials to ensure accurate quantities.
• Adhere to the production schedule, ensuring on-time internal production logistics.
• Record production data and information clearly and concisely according to GDPs.
• Perform all tasks in compliance with site safety policies, quality systems, and GMP requirements.
• Collaborate in a team-based, cross-functional environment to complete production tasks as per shift schedule.
• Demonstrate motivation and team-consciousness to meet job requirements.
• Become a Subject Matter Expert (SME) and qualified trainer within a designated manufacturing function.
• Complete training assignments on time to maintain necessary technical skills and process knowledge.
• Participate in continuous improvement projects, inspection readiness, and right-first-time initiatives, as assigned.
• Other duties as requested by management.

Qualifications – Knowledge, Skills, and Abilities:

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab techniques.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills and 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.

Education Requirements:

• Bachelor’s degree OR
• Associate / Medical Technical degree and 3 years of Manufacturing Operations experience OR
• High School diploma/GED and 2 years of Manufacturing or Operations experience.

Working Conditions (US Only):

• Intermittent walking and sitting; ability to sit or stand for extended periods may be necessary.
• Comfortable working with contained human blood components.
• Physical dexterity sufficient to use computers and documentation.
• Vision and hearing capability sufficient for job environment.
• Ability to lift up to 25 pounds.
• Must be able to work around laboratories and controlled, enclosed, restricted areas.
• Cleanroom garments and personal protective equipment (PPE) required in designated areas.
• Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
• Flexibility to don cleanroom garments and PPE.
• Cleanroom environment is e