Manufacturing Technical Operations Specialist III; MTO Specialist

Manufacturing Technical Operations Specialist III (MTO Specialist)

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq.

ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

We have an opportunity for a MTO Specialist, III to join our team and support manufacturing operations. In this role, you will help ensure batch record review and disposition schedules are met to adhere to lot release dates. You will lead root cause investigations, manage deviations, drive continuous improvement, and revise GMP documents such as SOPs and manufacturing batch records. This position offers the chance to work closely with cross-functional teams and contribute to high-quality biopharmaceutical manufacturing.

Monday - Friday, 8am-5pm

Harmans, MD - BWI 100% Onsite

• Initiate quality records and conduct deviation investigations that meet industry and Catalent expectations
• Lead or manage investigations including root cause analysis and assess product impact using input from various departments
• Develop, execute, and oversee Corrective and Preventive Actions (CAPAs)
• Provide technical leadership to ensure investigations are technically sound and corrective actions are effective
• Support technology transfer and process monitoring as needed
• Work with the team to monitor critical process parameters
• Revise and manage manufacturing documents such as batch records and Standard Operating Procedures (SOPs)
• Lead or support continuous improvement projects
• Conduct data gathering, trending, and data presentation to support investigations
• Provide real-time, on-the-floor response for operational deviations by gathering information and completing initial event reports
• Actively participate in training activities and manage individual training plans
• Perform other duties as assigned

• Master’s degree in a scientific, engineering, or biotech field with 6 years of experience in biopharmaceutical manufacturing processing in a Good Manufacturing Practice (GMP) compliance environment (e.g., production, development, process engineering, technical services or related field)
• OR Bachelor’s degree in a scientific, engineering, or biotech field with 8 years of experience in biopharmaceutical manufacturing processing in a GMP compliance environment
• OR Associate degree or high school diploma with 8-10 years of experience in biopharmaceutical manufacturing processing in a GMP compliance environment
• Strong knowledge of GMP regulations, FDA requirements, quality systems, and controlled documentation practices. Experience leading deviation investigations, root cause analysis, remediation activities, and system troubleshooting efforts, including major and critical deviations. Proven ability to author, revise, and maintain technical documentation with strong technical writing and communication skills. Demonstrated success working cross-functionally, leading teams, and executing projects on time and within budget…