Lead, Sterility Assurance

The Lead, Sterility Assurance will support the implementation and maintenance of highly performant Sterility Assurance Practices, Procedures and Systems on the Catalent MD sites. This position will lead the following areas: Aseptic processing in clean rooms, cleaning and disinfection process, environmental controls, and drug products compliance to regulations and standard in the subject of sterility assurance and contamination control. Review of sterile filter validations, integrity testing and procedures is also required. The individual is expected to interact with a cross functional team including validation, MS&T, QA, Facilities and QC. The primary responsibility is to maintain sterility assurance of aseptically manufactured sterile drug products and viral vector products to ensure meets GMP compliance standards (EU Annex, 21CFRs, ISO, USP)

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.

The role:

• Lead all aspects of aseptic filling operations, ensuring the sterility of product environments, implementing contamination control strategies, and maintaining operational excellence in isolators ensuring compliance with regulatory and quality standards (FDA, EU GMP).
• Execution of the site’s Sterility Assurance Strategy and Practices in collaboration with other Business Stakeholders, including in the following areas: Facility Design, HEPA filter certification, Facility Cleaning and Disinfection Program, Aseptic Gowning qualifications and dis-qualifications, Aseptic practices techniques/behaviors, including training of staff, Environmental Monitoring (viable and non-viable) and Contamination, particulates, endotoxin Controls.
• Utilize microbiological knowledge to develop contamination control strategies, interpret/support microbiological results from media fills, environmental monitoring, and sterility testing.
• Identify opportunities for process improvement in aseptic techniques, isolator efficiency, and overall contamination control strategies.
• Implement best practices and corrective actions; perform risk assessments related to aseptic processing, and microbial contamination. Develop mitigation strategies for potential sterility risks.
• Regularly GEMBA the aseptic practices and environmental monitoring practices on the shop floor to ensure adherence to implemented standard practices, processes and systems by all sites.

The candidate:

• Masters’ degree in a Microbiology, Engineering or Biotech field with 3-5 years’ experience in cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities
• Bachelor’s Degree in a Microbiology, Engineering or Biotech field with 5-7 years in relevant discipline required (e.g., cGMP Aseptic operations, Quality, Sterility Assurances, Contamination controls)
• Highly experienced in Biopharmaceutical, pharmaceutical manufacturing and/or aseptic processing working in a GMP environment.
• Demonstrate strong scientific understanding of DP Sterility Assurance and ability to investigate contamination events.
• Advanced experience in Aseptic Processing.

The anticipated salary range for this position in Maryland is $118,720-$163,240 plus an annual bonus target. The final salary 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:

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life