$10,000 Sign on Bonus

Evening shift 7pm-7am

Summary

The Supervisor, Manufacturing is responsible to lead a team of Manufacturing Associate professional while overseeing the GMP manufacturing process. The Supervisor, Manufacturing is responsible for assisting with developing and providing oversight for all training as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing.

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 delivery of services to our clients and impact the well-being of their patients.

The Role

• Supervisory responsibilities for a group of Manufacturing Associates including performance management.
• Responsible for training of new employees or existing team members
• Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps
• Generates operational protocol(s), internal or external documents including SOPs, BPRs, deviations and summary reports
• Works with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP
• Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs
• Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment
• Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions
• Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
• Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns
• Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines

Upstream:

• Leverage’s knowledge and application of the theories and principals utilized to solve operational, as well as routine tasks in the operation of microbial or cell culture processes (media/buffer prep, cell passaging, bioreactor production, harvesting operations)
• Have excellent understanding and knowledge of mammalian, insect, viral and microbial processes
• Experienced with suspension and adherent cell cultures
• Experienced in using stainless and disposable single-use bioreactors (WAVE, Sartorius, Xcellerex)
• Extensive experience in producing Master and Working banks (mammalian, insect, viral and microbial)

The Candidate

• HS or GED with 10 – 11 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance
• Associate degree in a Scientific, Engineering or Biotech field with 8 - 9 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance
• Bachelor’s degree in a Scientific, Engineering or Biotech field with 6 – 7 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance
• 2 years leadership experience including performance management responsibilities
• Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
• Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports

Shift work and/or weekend work is required at times.

Position Benefits:

• Opportunity to gain experience in the cutting-edge gene therapy space and help to develop critical lifesaving therapies for our clients
• 152 PTO Hours & 8 Holidays
• Medical, Dental & Vision Benefits and 401k
• Employee Stock Purchase Plan
• 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.

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.