Manufacturing Associate, CAR-T Abecma CAR-T

Position Title

Manufacturing Associate, CAR‑T, Manufacturing Operations

Manufactures human blood–derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required as applicable.

Wednesday–Saturday (with alternate Wednesday off), Onsite Night Shift, 5 p.m. – 5:30 a.m. Times may change based on business demands.

• Manufacture human blood‑derived cellular therapy products in accordance with SOPs and cGMP requirements.
• Perform cell culture maintenance and expansion, cell harvest, isolation, and cryopreservation activities.
• Execute aseptic processing activities, including tube welding, sampling, cell counts, sterile connections, and material transfers.
• Weigh and measure in‑process materials to ensure required quantities are added or removed.
• Adhere to production schedules and support on‑time manufacturing operations.
• Perform tasks for cell‑therapy products to support product Value Stream outputs according to cGMP, following the current approved SOPs and Work Instructions.
• Communicate production deviations and support quality investigations when required.
• Work collaboratively within a cross‑functional, team‑based manufacturing environment.
• Perform mandatory activities within the designated manufacturing function as assigned.
• Perform additional manufacturing‑related tasks as directed by management.
• Support manual and electronic batch record executions, deviation investigations, and closure of CAPAs.
• Maintain timing according to the production schedule to ensure on‑time logistics.
• Ensure all documentation is correct and addresses procedural/documentation errors expeditiously and effectively.
• Remain available to work overtime when business requires and to work staggered day shift hours as needed.
• Record patient material handling data and information in a clear, concise format according to proper GDPs.
• Available to work overtime when business requires.

• Basic understanding of cell culture, cryopreservation, cell expansion, aseptic processing techniques, and laboratory techniques.
• Knowledge and understanding of cGMP and FDA‑regulated manufacturing environments.
• Technical writing and documentation skills.
• Proficiency in Microsoft Office applications.
• Foundational knowledge of biology, chemistry, and mathematics.
• Strong teamwork and communication skills.
• Ability to work effectively in a fast‑paced manufacturing environment.
• Inventory control and/or management skills.

• Bachelor’s Degree; OR
• Associate degree/Medical Technical Degree with at least 2 years of manufacturing or operations experience; OR
• High School Diploma/GED with at least 4 years of manufacturing or operations experience.

• Work within a controlled cGMP cleanroom environment.
• Routine exposure to human blood components.
• Required to wear cleanroom garments and personal protective equipment, including coverings for head, face (partial), body, legs, and feet.
• Work in enclosed, restricted cleanroom areas with controlled pressure and temperature.
• Exposure to reagents, manufacturing chemicals, and sanitization agents.
• Must comply with cleanroom restrictions, including prohibition of makeup, gum, nail polish, and personal electronic devices in designated areas.
• Ability to stand or sit for extended periods; frequent walking and movement throughout the manufacturing area.
• Ability to use computers and complete documentation tasks.
• Ability to lift up to 25 pounds.
• Must possess sufficient vision and hearing to perform job duties safely.
• Must be flexible with production schedules, including weekend shifts and potential schedule changes based on business needs.

Summit West - NJ - US: $27.83 – $33.72 per hour. The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional…