Manager, Manufacturing Technical Operations Role
About Site
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.
Position Summary
We have an opportunity for a Manager, Manufacturing Technical Operations to join our team. In this role, you will lead and oversee the Manufacturing Technical Operations group that supports manufacturing operations at Catalent. The team’s functions include investigations, deviations, continuous improvement, operational excellence, technology transfer support, document management, bill of materials management, data analytics, scheduling, and suite readiness. This position reports to the Director, MTO and manages a team of specialists dedicated to ensuring operational success.
Shift: Monday - Friday, 8am-5pm
Location: Harmans, MD - BWI
100% Onsite
The Role
Build, lead, and manage the Manufacturing Technical Operations group to support ongoing and future manufacturing operations, ensuring staff are fully trained on all current Good Manufacturing Practice operations and documentation while adhering to safety guidelines
Manage the interface of the group with internal stakeholders and clients through proactive communication and accountability for on-time project and work completion; interact with clients on projects and presentations; oversee and coach team member client interactions
Oversee daily activities for the group to ensure quality results, including performance management for direct reports and driving timely completion of major manufacturing investigations, deviations, and subsequent Corrective and Preventive Actions
Provide oversight and coordination of manufacturing continuous improvement activities such as Corrective and Preventive Actions and Change Controls, and operational excellence initiatives; establish and manage a yearly slate of improvement projects with measurable results aligned with site objectives
Support technology transfer teams led by Manufacturing Science and Technology by providing or coordinating manufacturing representation
Provide effective oversight and coordination of manufacturing document generation and revision, bill of materials management, operations data analytics and metrics, manufacturing finite scheduling, and manufacturing suite readiness to ensure timely completion
Other duties as assigned
The Candidate
Minimum Requirements
Master’s degree in a Scientific, Engineering, or Biotech field with 6 years of experience in current Good Manufacturing Practice production and/or quality experience, with knowledge and understanding of process, documentation requirements, and activities; or
Bachelor’s degree in a Scientific, Engineering, or Biotech field with 8 years of experience in current Good Manufacturing Practice production and/or quality experience, with knowledge and understanding of process, documentation requirements, and activities
Minimum 3 years of progressive leadership experience, including performance management and people development
Knowledge of Good Manufacturing Practices, Food and Drug Administration regulations, and documentation procedures required
Experience in quality systems regulations; previous experience in…