Manufacturing Associate III

Manufacturing Associate III

Position Summary:  

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Our U.S. commercial cell therapy manufacturing facility is located in Princeton, NJ, and is part of Catalent’s cell therapy network including our European Center of Excellence for cell therapy in Gosselies, Belgium.

The CGMP manufacturing facility is equipped with 16 flexible clean rooms, QC labs, and warehouse space to support late-stage and commercial-scale autologous and allogeneic cell therapy production.

The Manufacturing Associate III is responsible for advising and supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to perform operational, as well as routine tasks in the production of cell therapy and/or human cells cultivation.

The Manufacturing Associate III will report to the Manager, Manufacturing.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

This is a full- time, salaried, position:  Monday – Friday, 7:00 am – 3:30 pm.

The Role: 

• Perform and support clinical and commercial manufacturing activities, including cell culture, aseptic processing, cell counts, expansion, separation, and cryopreservation, in compliance with cGMP, FDA, and safety regulations.
• Develop, finalize, and review production-related documentation (SOPs, batch records, forms, and protocols) and ensure manufacturing logbooks are accurate and up to date.
• Coordinate daily production scheduling, line clearance, and documentation activities with Manufacturing Supervisors and QA.
• Train and mentor Manufacturing Associates on aseptic techniques, processes, and compliance expectations.
• Lead or support investigations, deviations, CAPAs, and batch record reviews/closures to ensure timely resolution and regulatory compliance.
• Collaborate with Manufacturing Supervisors on new and ongoing projects, ensuring processes and techniques meet operational and contract objectives.
• Troubleshoot manufacturing processes and equipment issues, partnering with Facilities and Validation to maintain proper functionality.
• Serve as a subject matter expert (SME) on bioreactors, incubators, controlled rate freezers, cryopreservation, disposable single-use technology, cell selection/depletion/separation, electroporation, centrifugation, and aseptic processing; oversee equipment calibration, validation, and qualification.
• Maintain facility and cleanroom standards, including cleaning/disinfection of classified areas and strict adherence to environmental health and safety (EHS) regulations.
• Identify, develop, and implement process improvements to enhance operational efficiency, product quality, and compliance.
• Additional duties as assigned.

The Candidate:

• High school diploma with at least 4 years of GMP manufacturing experience (associate degree preferred) OR bachelor’s degree in a scientific or engineering discipline with a minimum of 3 years of GMP manufacturing experience.
• Extensive experience in cell culture, cell counts, cell expansion (incubators), cell washing, cell separation, cryopreservation, and aseptic manipulations in a Biosafety Cabinet (BSC) preferred; strong aseptic technique and good documentation practices required.
• Experience working in cleanroom environments (Grade A, B, C, and D) with the ability to perform tasks while fully gowned in aseptic attire for extended periods required.
• Experience working with Biologics and/or Cell Therapy required; experience with CAR-T and CRISPR preferred.
• Experience in biopharmaceutical GMP manufacturing operations, cell therapy, or human cell cultivation required.
• Hands-on experience opera