Manufacturing Associate I

Manufacturing Associate I

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 Catalents cell therapy network including our European Center of Excellence for cell therapy inGosselies 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 I is responsible for supporting the overall GMP manufacturing process while adhering to Standard Operating Procedures in a controlled Clean Room environment and following cGMP guidelines and FDA standards and safety regulations.

The Manufacturing Associate I 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 all manufacturing for both clinical and commercial activities that meet the sites strategic objectives and is compliant with cGMPs safety regulations and FDA standards.
• Executes and completes Batch Production Records under cGMP and documents in detail using SOPs FORMS and Work Instructions for the processes and 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 communicates 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 any manufacturing materials or components to support clinical/commercial operations in a clear and timely manner.
• Support Shift supervisors as well as Manufacturing Associate IIIs with current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays.
• Organize store and perform inventory of all clean room supplies.
• Promptly communicate any equipment malfunctions or breakdowns to area management in a timely manner
• Perform cleaning and disinfection of classified manufacturing areas in accordance with established procedures while strictly adhering to environmental health and safety (EHS) regulations.
• Additional duties as assigned.

The Candidate:

• High school diploma with a minimum of 2 years of GMP manufacturing experience; OR associate degree in a scientific engineering or biotechnology discipline with at least 1 year of related experience (biotechnology coursework highly desirable); OR bachelors degree (BS/BA) in a scientific or engineering discipline from an accredited institution; 01 year of relevant experience required with 1 year preferred.
• Hands-on experience in biologics or cell therapy (e.g. CAR-T CRISPR) with exposure to cell culture cell counts/expansion cell washing separation cryopreservation aseptic manipulations in a biosafety cabinet (BSC) and/or CDMO operations; prior cleanroom and Grade AD gowning experience preferred.
• Familiarity with cGMP/FDA-regulated environments and demonstrated use of aseptic techniques and good documentation practices.
• Strong problem-solving and organizational skills with the ability to work under pressure while meeting timelines.
• Excellent verbal and written communication skills in English; proficiency in MS Office (Word Excel PowerPoint Outlook) and basic mathematical skills.
• 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 BD) with full gowning and aseptic techniques; occasional exposure to moving mechanical parts biohazards (including human blood components) and risk of electrical shock.

The anticipated salary range for this position in New Jersey is $32.21 - $38.46 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 7000 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 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 . 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 for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.