Manufacturing Associate – CAR-T Operations

Manufacturing Associate – CAR-T Operations

Location: Raritan, NJ (On-site)

Shift: Night Shift

Employment Type: Contract with potential for permanent conversion

The Manufacturing Associate will support the production of autologous CAR-T cell therapy products within a cGMP manufacturing environment. This role is responsible for executing manufacturing processes, maintaining accurate documentation, and supporting production activities while adhering to quality, safety, and regulatory requirements.

This position supports a highly regulated manufacturing operation and requires the use of PPE and cleanroom gowning procedures.

• Execute manufacturing and manufacturing-support activities in accordance with SOPs, batch records, and training requirements.
• Perform cell culture, purification, processing, and cryopreservation activities using approved techniques and procedures.
• Accurately document production activities in batch records, logbooks, and GMP documentation.
• Perform process unit operations in compliance with cGMP requirements and Good Documentation Practices (GDP).
• Work collaboratively with manufacturing, quality, engineering, and support teams to meet production objectives.
• Support process improvements and operational excellence initiatives.
• Assist with manufacturing investigations and deviation-related activities as required.
• Ensure materials and supplies are available to support manufacturing operations.
• Maintain a clean, safe, and compliant work environment.
• Participate in audit preparation and support inspection activities.
• Demonstrate successful progression through assigned training curricula.
• Handle human-derived materials within designated manufacturing areas.
• Support production schedule adjustments as business needs require.

This position supports a 24/7 manufacturing operation utilizing 12.5-hour shifts
.

Night Shift

• Start time between 5:30 PM and 6:30 PM
  , depending on workload.

The operation consists of four shift teams covering seven days per week:

Primary need: Thursday, Friday, Saturday night shift team.

Occasional openings: Sunday, Monday, Tuesday night shift team.

Employees alternate between:

This rotating schedule provides continuous 24/7 manufacturing coverage.

Overtime is paid at 1.5x the regular hourly rate.

One of the following is required:

• High School Diploma with 3–5 years of biotech, pharmaceutical, or manufacturing experience; OR
• Associate's degree in Life Sciences, Manufacturing, or a related field with 2–3 years of relevant experience; OR
• Bachelor's degree in Life Sciences or a related discipline with 0–2 years of relevant experience.

• Ability to follow written and verbal instructions and standard operating procedures.
• Strong attention to detail and documentation skills.
• Ability to work effectively in a team-based manufacturing environment.
• Knowledge of cGMP and GDP principles preferred.
• Experience operating manufacturing, laboratory, or manufacturing-support equipment preferred.
• Basic understanding of process improvement methodologies and operational excellence tools.
• Ability to perform routine testing, sampling, and manufacturing activities.
• Strong communication and interpersonal skills.
• Ability to troubleshoot and solve practical production-related issues.
• Proficient basic math skills.
• Ability to stand, walk, bend, climb, and move throughout the shift.
• Ability to lift up to 25 pounds.
• Ability to wear required PPE and perform cleanroom gowning procedures.
• Ability to work around biological materials and hazardous chemicals.

• Visual acuity of at least 20/40 (corrected or uncorrected).
• Ability to distinguish colors as required for manufacturing processes.

Note: This position offers the opportunity to gain experience in a leading CAR-T manufacturing environment and may convert to a permanent employee role based on performance and business needs.