Lead Specialist, Sterility Assurance

Lead Specialist, Sterility Assurance Role

About Site

Catalent’s Baltimore site is a leading facility specializing in biologics development and manufacturing, offering state-of-the-art capabilities to support advanced therapies. The campus provides a collaborative environment where teams work on innovative solutions for clinical and commercial supply, including cell and gene therapies. With modern laboratories, cutting-edge technology, and a strong focus on quality, the site plays a key role in delivering life-changing treatments to patients worldwide. This location fosters a culture of excellence and teamwork, making it an exciting place for professionals passionate about science and innovation to grow their careers.

Position Summary

We have an opportunity for a Lead Specialist, Sterility Assurance to join our team. In this role, you will support the implementation and maintenance of sterility assurance practices, procedures, and systems across Catalent Maryland sites. You will lead aseptic processing in clean rooms, cleaning and disinfection processes, environmental controls, and ensure compliance with regulations and standards. This position requires collaboration with cross-functional teams to maintain sterility assurance for aseptically manufactured sterile drug products and viral vector products, ensuring compliance with GMP standards.

Shift: Monday - Friday 8am-5pm Location: Harmans, MD - BWI 100% Onsite

The Role

• Lead all aspects of aseptic filling operations, ensuring sterility of product environments, implementing contamination control strategies, and maintaining compliance with regulatory and quality standards.
• Execute the site’s Sterility Assurance Strategy and Practices in collaboration with stakeholders, including facility design, HEPA filter certification, cleaning and disinfection programs, aseptic gowning, aseptic practices, environmental monitoring, and contamination controls.
• Use microbiological knowledge to develop contamination control strategies and interpret microbiological results from media fills, environmental monitoring, and sterility testing.
• Identify opportunities for process improvement in aseptic techniques and contamination control strategies.
• Implement best practices and corrective actions; perform risk assessments and develop mitigation strategies for sterility risks.
• Regularly observe aseptic and environmental monitoring practices on the shop floor to ensure adherence to standards.
• Lead sterility assurance-related deviation investigations and change controls with cross-functional teams.
• Apply knowledge of Quality Management Systems, including Change Controls, Deviations, CAPAs, and Investigations.
• Support implementation and continuous improvement of sterility assurance practices and systems.
• Provide technical support for new filling lines and equipment during design, qualification, validation, and start-up.
• Offer microbiological and sterility expertise for cGMP documents such as SOPs, batch records, and validation reports.
• Lead contamination control and sterility assurance practices for aseptic production processes to minimize risk.
• Serve as a subject matter expert in sterility assurance and aseptic operations, participate in regulatory inspections, and assist in quality assessments.
• Other duties as assigned.

The Candidate

Minimum Requirements

• Master’s degree in Microbiology, Engineering, or Biotech with 4+ years of professional experience in cGMP production or quality, or Bachelor’s degree in these fields with 7+ years of relevant experience.
• Extensive experience in biopharmaceutical or pharmaceutical manufacturing and aseptic processing in a GMP environment.
• Strong scientific understanding of drug product sterility assurance and ability to investigate contamination events.
• Advanced experience in aseptic processing.
• Ability to work effectively in a team-oriented environment under dynamic conditions.
• Excellent communication, technical writing, organizational skills, and proficiency in Microsoft Office.
• Ability to understand product-patient mindset and assess health, compliance, and financial risks.
• Ability to influence without authority across multiple teams including quality, manufacturing, engineering, MS&T, facilities, and validation.

Preferred Skills & Background

• Experience with or strong understanding of Failure Mode and Effects Analysis (FMEA) and New Product Introduction.

Pay

The anticipated salary range for this position in MD is $120,000 – $150,000 Plus Bonus. 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

• Defined career path with annual performance reviews and feedback.
• Diverse and inclusive culture.
• Opportunities for career growth within an organization dedicated to improving lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective from day one.
• Tuition reimbursement program.

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.

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.

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