Lead Specialist, Sterility Assurance

Catalent is seeking a Lead Specialist, Sterility Assurance to join our biologics manufacturing facility in Harmans, Anne Arundel County. This is a full-time position at our state-of-the-art Baltimore-area campus, where you'll play a critical role in ensuring product safety and regulatory compliance for cell and gene therapies and clinical biologics.

About the Role

As Lead Specialist, Sterility Assurance at Catalent, you'll oversee sterility testing operations and contamination control programs that support the development and manufacturing of advanced therapies. Your expertise will directly impact the quality and safety of products serving patients worldwide. You'll work across departments to establish and maintain rigorous standards for all sterility-related activities on our campus.

What You'll Do

• Design, validate, and execute sterility testing protocols in compliance with USP, EP, and FDA requirements
• Develop and implement contamination monitoring strategies and environmental controls
• Review and approve sterility test results, ensuring accuracy and regulatory adherence
• Provide technical guidance on aseptic processing and sterile manufacturing practices
• Investigate sterility test failures and deviations, documenting root causes and corrective actions
• Support method transfers and process scale-up activities from development through commercial production
• Collaborate with quality assurance, manufacturing, and regulatory affairs teams

What We're Looking For

• Advanced degree in microbiology, pharmaceutical sciences, or a related discipline (or equivalent professional experience)
• Demonstrated expertise in sterility testing and microbiological methods
• Deep knowledge of GMP regulations and industry standards for biologics manufacturing
• Experience with method validation and process risk assessment
• Strong written and verbal communication skills for cross-functional collaboration
• Ability to lead technical initiatives and mentor team members
• Detail-oriented approach with a commitment to product quality and patient safety

About Catalent

Catalent's Harmans facility is a leading hub for biologics development and manufacturing in Maryland, equipped with modern capabilities to support innovative therapies including cell and gene therapies. We foster a collaborative environment where your technical expertise directly contributes to bringing advanced medicines to market.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.