Manufacturing Associate I

Overview

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 supports product development, launch, and full life-cycle supply for pharma, biotech, and consumer health customers. With experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent accelerates development programs and launches numerous new products annually. Catalent operates globally with thousands of scientists and technicians across more than 40 sites, supplying billions of doses of life-enhancing and life-saving treatments.

Our U.S. commercial cell therapy 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 facility features 16 flexible clean rooms, QC labs, and warehouse space to support late-stage and commercial-scale autologous and allogeneic cell therapy production. This role is within the Manufacturing team and reports to the Manager, Manufacturing.

The Role

• Perform and support all manufacturing for both clinical and commercial activities that meet the site's objectives and are compliant with cGMPs, safety regulations, and FDA standards.
• Execute and complete Batch Production Records under cGMP, documenting in detail using SOPs, forms, and work instructions for manufacturing steps.
• Execute production activities that include cell culturing, aseptic processing, cell counts, expansion, separation, and cryopreservation using appropriate techniques and equipment.
• Identify process improvements and communicate them to management in a timely manner.
• Collaborate with the Process Development and Manufacturing Sciences and Technology (MS&T) group to transfer new projects into GMP.
• Generate required requisition forms and communicate with department members regarding manufacturing materials or components to support clinical and commercial operations in a clear and timely manner.
• Support Shift Supervisors and Manufacturing Associates with current and new projects and help develop processes / techniques to meet contract objectives and avoid delays.
• Organize, store, and perform inventory of all clean room supplies.
• Promptly communicate any equipment malfunctions or breakdowns to area management.
• Perform cleaning and disinfection of classified manufacturing areas in accordance with procedures while adhering to EHS regulations.
• Additional duties as assigned.

The Candidate

The anticipated salary range for this position in New Jersey is $32.21 - $38.46 plus overtime pay and annual bonus, when eligible. Final hourly rate will vary based on factors including experience, education, and business needs. Catalent is a multi-state employer, and this range may not reflect roles in other states.

Why you should Join Catalent

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require accommodation during the hiring process, please contact DisabilityAccommodations@catalent.com with the job number, title, and location. This notice is provided for equal opportunity and compliance purposes.

Notice to Agency and Search Firm Representatives : Catalent is not accepting unsolicited resumes from agencies or search firms for this job posting. Resumes submitted without a valid written agreement may be considered the property of Catalent. No fees will be paid for unsolicited referrals.

Important Security Notice to U.S. Job Seekers : Catalent never asks candidates for payment or sensitive information during the offer process. If you receive such requests, do not respond and forward to spam@catalent.com for investigation.

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