Senior Cell Therapy Manufacturing Associate (GMP)

Catalent Pharma Solutions LLC; Princeton (NJ); On-site; USD 56,000 - 63,000; Full time

Benefits offered by this job

Health benefits on day one

8 paid holidays

Tuition reimbursement

Job summary

Catalent has an opening for a Manufacturing Associate III at its Princeton, NJ site. This role supports GMP manufacturing for clinical and commercial cell therapy programs, performing core production activities while ensuring quality and compliance.

You will collaborate with cross‑functional teams, document processes, mentor peers, and drive continuous improvement in a fast‑paced, regulated environment. Previous experience with cell culture, aseptic processing, and cGMP is required.

Qualifications

• Hands-on experience with cell culture, cell expansion, cell counting, cell separation, cryopreservation, and aseptic processing in GMP-regulated environments.
• Experience supporting biologics, cell therapy, or advanced therapy manufacturing processes, including CAR‑T, CRISPR, or related technologies.
• Strong knowledge of FDA regulations, GMP requirements, aseptic techniques, and Good Documentation Practices (GDP).

Responsibilities

• Support manufacturing operations for clinical and commercial cell therapy programs through the execution of cGMP-compliant production activities.
• Coordinate daily production scheduling and resource planning in partnership with Manufacturing leadership.
• Execute and oversee key manufacturing processes, including cell culture, aseptic processing, cell expansion, separation, counting, and cryopreservation.
• Assist with the development, review, and maintenance of manufacturing documentation, including SOPs, work instructions, forms, and protocols.
• Train and mentor Manufacturing Associates in technical operations, aseptic techniques, and cGMP requirements.
• Lead deviation investigations, CAPA implementation, and manufacturing troubleshooting to resolve process and equipment issues.

Skills

Cell culture

Aseptic processing

GMP regulations

Cross-functional teamwork

Documentation practices

Education

High School Diploma

Associate degree in scientific/engineering/biotech

Bachelor’s degree in scientific or engineering discipline

Job description

Catalent has an opening for a Manufacturing Associate III at its Princeton, NJ site. This role supports GMP manufacturing for clinical and commercial cell therapy programs, performing core production activities while ensuring quality and compliance.

You will collaborate with cross‑functional teams, document processes, mentor peers, and drive continuous improvement in a fast‑paced, regulated environment. Previous experience with cell culture, aseptic processing, and cGMP is required.