Manufacturing Associate I Jobs

Summary

Catalent Cell & Gene Therapy is looking to recruit a Manufacturing Associate I, to join our growing team in Princeton, NJ.

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.

This position is 2nd shift. Workdays and hours will be Monday - Friday; 2:00 pm - 10:30 pm and may require 1st shift or weekends as needed. Catalent reserves the right to adjust your shift based on business needs and changes.

Catalent is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Catalent Cell and Gene Therapy provides process development, process characterization, and GMP manufacturing services to industry leaders utilizing novel technologies to produce state-of-the-art vaccines and gene therapies. As a Catalent employee, you will actively contribute to the delivery of services to our clients and impact the well-being of their patients.

The Role:

• Perform and support all manufacturing for both clinical and commercial activities that meet the site’s strategic objectives and is compliant with cGMP’s, safety regulations, and FDA standards.
• Perform cleaning/disinfection of the manufacturing classified areas as needed per area procedure.
• Execute production activities that include cell culturing, aseptic processing, cell counts, expansion, separation and cryopreservation using appropriate techniques and equipment.
• Always follow environmental health and safety (EHS) rules and regulations.
• Collaborates with the manufacturing leadership and MS&T to assist closing deviations as well as CAPAs in a timely manner.
• Collaborate with the Process Development and Manufacturing Sciences and Technology (MSAT) group to transfer new projects into GMP.
• Work with Facilities and Engineering to ensure proper functionality of equipment by initiating Work Orders as needed.
• Generate and revise internal and external documents (SOPs, Batch Records)
• Work closely with Supervisors and MA III’s for current and new manufacturing projects. Assist with processes/techniques to meet contract objectives in a timely manner.
• Executes and completes Batch Production Records under cGMP, and documents in detail using SOPs and BPRs for the processes and manufacturing steps.
• Additional duties as assigned.

The Candidate:

• Familiarity with cGMP/FDA regulated industry.
• Ability to apply scientific principles utilized to solve operational, as well as routine production tasks.
• Excellent oral and written communication skills. Strong technical writing ability preferred.
• Grade A, B, C and D gowning experience highly desirable.
• High School Diploma or GED with a minimum of 2 years of GMP Manufacturing experience. OR Associate degree in a scientific, engineering or biotechnology discipline with a minimum of 1-2 years related experience; coursework with biotechnology focus highly desirable. OR Bachelor’s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and a minimum of 0-1 years relevant experience.
• Experience in Cell Culture, Cell counts, Cell expansion (incubators), Cell Washing, Cell Separation, Cryopreservation, and aseptic manipulations in a Biosafety Cabinet (BSC) is highly preferred.
• Experience in biologics manufacturing, sterile manufacturing, quality assurance or engineering areas is preferred.
• CDMO experience preferred.

Physical Requirements:

• Ability to lift/push upwards of 50lbs.
• Ability to work with sporicidal agents such as SporKlenz and cleaning solutions; Ability to perform cleaning using a telescopic mop to clean ceilings/walls and floors.
• Must be able to work/being exposed to human blood components.

• A minimum 20/20 vision with or without correction with both eyes with completion of the Graham Field Eye Test Chart from 10 Feet
• Must be able to identify colors on the Ishihara Charts of Color Deficiency
• Visual Acuity Requirements:
  • A minimum 20/20 vision with or without correction with both eyes with completion of the Graham Field Eye Test Chart from 10 Feet
  • Must be able to identify colors on the Ishihara Charts of Color Deficiency
  • If prescription is required and changes in the course of employment with Catalent, must complete new Visual Acuity Assessment with or without correction to meet the above requirements.
• If prescription is required and changes in the course of employment with Catalent, must complete new Visual Acuity Assessment with or without correction to meet the above requirements.

Why You Should Join Catalent:

• Employee Stock Purchase Plan
• Defined career path and annual performance review & feedback process
• Medical, Dental, Vision, and 401K are all offered from day one of employment
• Potential for career growth within an expanding team
• Cross-functional exposure to other areas within the organization
• 19 days PTO and 8 paid holidays

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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 [email protected]. 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 [email protected] for us to investigate with local authorities.

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