Lead Specialist, Sterility Assurance

Catalent•Harmans, MD

2d•$120,000 - $150,000•Onsite

About The Position

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. 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

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.

Nice To Haves

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

Responsibilities

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.