Summary

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

Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology, and consumer health industry. In this position, the Manufacturing Supervisor is responsible for Organizing and supervising daily Manufacturing activities and ensure the Manufacturing Schedule is followed in a timely manner.

This role will provide hands-on direction for manufacturing personnel and activities. This position requires extensive technical expertise in aseptic techniques. Provide expertise in writing/reviewing SOPs, Batch Records, Deviations, CAPA’s and other technical document/compliance documents as it relates to Manufacturing Operations.

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:

• Supervise a team of manufacturing technicians daily, maintaining adherence to a demanding production schedule.
• Leads a manufacturing team to identify issues and propose adequate solutions. Optimize the utilization of available resources to ensure production objectives are met.
• Leads 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.
• Ensure batches adhere to established Quality standards.
• GMP batch review and close-out with Quality Assurance group in a timely manner.
• Ensure the completeness and accuracy of manufacturing documentation per approved procedures.
• Identify and support the implementation of process efficiencies and areas for improvement
• Responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating performance and rewarding as appropriate.
• Have a background in GMP management either in leading projects or personnel management.
• Be able to provide assistance in a clean room environment with aseptic gowning for long periods of time. Good mechanical aptitude, familiar with general equipment associated with Cell and Gene Therapy Processing.
• Responsible to conduct 1-1 meetings on at least 2 times per month with direct reports to establish performance standards, employee coaching and development, determining employee responsibilities, evaluating performance, and rewarding as appropriate.
• Additional duties as assigned.

The Candidate:

• High School Diploma or GED with a minimum of 10-11 years of GMP Manufacturing experience. OR Associate degree in a scientific, engineering or biotechnology discipline with a minimum of 8-9 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 6–7-year relevant experience.
• 2 years leadership experience (lead or senior roles) including performance management responsibilities highly desirable. CDMO experience preferred.
• Flexibility with work schedule – accommodate changes in the schedule including working on other shifts as per operational needs (1st or 2nd shift) and weekends as needed.
• Solid knowledge and understanding of FDA regulations and GMP systems.
• Highly experienced in Cell Culture, Cell counts, Cell expansion (incubators), Cell Washing, Cell Separation, Cryopreservation, and aseptic manipulations in a Biosafety Cabinet (BSC) is highly preferred.
• SME (subject matter expert) in technical knowledge of bioreactors, incubators, controlled rate freezers, cryopreservation, disposable single use technology, cell selection/depletion/separation, electroporation, centrifugation, and aseptic processing.
• Excellent oral and written communication skills. Strong technical writing ability is required.

Physical Requirements:

• Must be able to work/being exposed to human blood components.
• 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.
• Ability to lift/push upwards of 50lbs.

• 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.

Why You Should Join Catalent:

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