Supervisor Fill/Finish

This is a 2nd shift position. Monday-Friday 2:00pm-10:30pm. 

The Supervisor Fill/Finish is responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for Phase I/II & commercial GMP manufacturing.

The Supervisor is critical to our patients. Manufacturing life-saving medicines right the first time with patient safety in mind is our priority.  Quality, safety and on-time delivery is a must to be successful in this role!

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

• Produce clinical and commercial material on an annual basis that meets the site's strategic objects and is compliant with cGMPs and safety regulations.
• Point person on shift to assign/distribute the work and coordinate emergency situations.
• Ensure documentation (batch records and SOPs) are accurate and updated as required.
• This role is responsible for the accurate, safe, environmentally responsible, and quality compliant operations of the manufacturing process.
• Facilitates GMP and Safety training of GMP staff, with a focus on cross-training and continuously improvement 
• Recommends equipment, supply purchases within the production areas   
• Exhibit safety leadership by example (e.g., utilize proper PPE when performing job functions)
• Demonstrate an appropriate level of understanding of the operations performed in the production unit
• Responsible for shift schedule and summarizing shift progress at the end of the shift
• Lead and mentor staff. Write performance reviews and annual goals, hold one-on-ones.
• Effectively communicate results of departmental work through team discussions and documentation  
• Ensure cGMP compliance and all its related elements in documentation, reports and records  
• Initiate non-conformances when identified and complete investigations to support on-time closure of deviation
• Understand and review current regulations, industry guidance, and other applicable professional documentation

The Candidate

• Preferred B.S. in Engineering or Science discipline and a minimum of 5-8 years of experience in biopharmaceutical based GMP manufacturing operations, related technical field, or equivalent industry experience.  (Some or all this experience should be in fill/finish processing)
• Experience with GMP fill finish operations and sound understanding of the drug development process  
• Minimum of 3 years of leadership experience required
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.

Position Benefits:

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

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.