Manufacturing Associate III

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

Manufacturing Associate III

About Site

Catalent’s Princeton, New Jersey site is a key part of the company’s cell therapy network and serves as a U.S. commercial manufacturing facility for autologous and allogeneic cell therapies. The site is equipped to support the full product lifecycle, including late‑stage clinical development, process characterization, and commercial‑scale CGMP manufacturing across a wide range of cell types. With flexible cleanroom suites, quality control laboratories, and an experienced technical team focused on scalable, single‑use manufacturing approaches, the Princeton site enables reliable production and supply of advanced cell‑based therapies. As part of Catalent’s global Cell & Gene Therapy organization, the Princeton facility plays a strategic role in helping partners advance complex, personalized medicines toward commercialization.

Position Summary

We have an opportunity for a Manufacturing Associate III to join our team and contribute to the production of advanced cell therapies. This role involves supporting and performing GMP manufacturing processes, applying technical knowledge to ensure quality and compliance. The position requires collaboration with cross‑functional teams to maintain operational excellence and continuous improvement. The Manufacturing Associate III will play a key role in ensuring the success of both clinical and commercial manufacturing programs.

The Role

• 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.
• Serve as a subject matter expert in cell therapy manufacturing processes, media preparation, cryopreservation, and Biological Safety Cabinet operations.
• Lead deviation investigations, CAPA implementation, and manufacturing troubleshooting to resolve process and equipment issues.
• Drive continuous improvement initiatives to enhance process efficiency, quality, compliance, and operational performance.
• Support validation and qualification activities, including equipment, cleanroom, calibration, and process‑related protocols.
• Maintain inspection readiness by ensuring compliance with cGxP, FDA, safety, cleaning, documentation, and facility/equipment requirements, including batch record and logbook review.
• Perform additional duties as assigned.

Candidate Minimum Requirements

• High School Diploma with 4–6 years of GMP manufacturing experience, OR Associate degree in a scientific, engineering, or biotechnology discipline with 4 years of related experience, OR Bachelor’s degree in a scientific or engineering discipline with 3 years of relevant experience.
• Experience supporting biologics, cell therapy, or advanced therapy manufacturing processes, including CAR‑T, CRISPR, or related technologies.
• Hands‑on experience with cell culture, cell expansion, cell counting, cell separation, cryopreservation, and aseptic processing in GMP‑regulated environments.
• Proven ability to work in Grade A, B, C, and D cleanrooms while maintaining aseptic gowning and contamination control standards.
• Strong knowledge of FDA regulations, GMP requirements, aseptic techniques, and Good Documentation Practices (GDP).
• Technical expertise with manufacturing equipment and technologies, including bioreactors, incubators, centrifuges, electroporation systems, controlled‑rate freezers, cell selection platforms, and single‑use technologies.
• Experience operating, troubleshooting, and maintaining cell therapy manufacturing equipment, including cell counters, separation systems, and liquid nitrogen storage systems.
• Strong communication, technical writing, leadership, and interpersonal skills, with the ability to collaborate across cross‑functional teams, mentor peers, drive continuous improvement initiatives, and excel in a fast‑paced manufacturing environment with evolving priorities and deadlines.

Physical requirements

Ability to work in GMP‑controlled environments while fully gowned, including prolonged standing or sitting, handling human‑derived materials, lifting or moving up to 50 lbs., performing cleaning and sanitation activities, maintaining accurate documentation, working safely around biohazardous materials and manufacturing equipment, and meeting required visual acuity standards.

Preferred Skills & Background

CDMO experience highly preferred.

Pay

The anticipated hourly rate for this position in NJ is $40.86 – $45.67 plus bonus. The final hourly rate offered to a successful candidate may vary and will depend on factors such as experience, skillset, education, and business needs. 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 with annual performance reviews and feedback. Diverse and inclusive culture. Opportunities for career growth within a team dedicated to improving lives. Competitive paid time off plus 8 paid holidays. Community engagement and green initiatives. Medical, dental, and vision benefits effective on day one of employment. Tuition reimbursement program. 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.

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 [e-mail]. 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.

Volunteer Work Disclosure

Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.

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.