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 operating cell counters, cell separation machines, electroporation machines, centrifuges, incubators, controlled rate freezers, and liquid nitrogen storage tanks preferred.
Excellent verbal and written communication skills in English, including strong technical writing, problem-solving, and organizational abilities, with the capacity to work under pressure and meet deadlines required.
Flexibility to work across shifts (1st, 2nd, 3rd), including holidays and weekends, as required by business needs.
Must meet physical requirements including computer/equipment use, accurate documentation, ability to lift/push up to 50 lbs., work in tight spaces, handle sporicidal agents/cleaning solutions, and perform ceiling-to-floor cleaning.
Vision and environmental requirements include willingness to undergo visual acuity testing (Graham Field Eye Test from 10 feet and Ishihara Charts of Color Deficiency) and the ability to work in controlled cleanroom environments (Grade B-D) with full gowning and aseptic techniques; occasional exposure to moving mechanical parts, biohazards (including human blood components), and risk of electrical shock.
The anticipated hourly rate for this position in New Jersey is $38.46 - $50.96 plus overtime pay and annual bonus, when eligible. The final hourly rate offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the @type and length of experience within the job, @type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
Why you should Join Catalent:
Defined career path and annual performance review and feedback process.
Diverse, inclusive culture.
Potential for career growth on an expanding team.
Cross-functional exposure to other areas within the organization.
152 hours of paid time off annually + 8 paid holidays.
Medical, dental, vision and 401K benefits effective day one of employment.
Tuition Reimbursement.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any @type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .
