Manager, Manufacturing Technical Operations

Manager, Manufacturing Technical Operations (MTO)

Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

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.

The Manager, Manufacturing Technical Operations (MTO) is responsible for oversight and leadership of MTO group that supports manufacturing operations at Catalent.  The Manufacturing Technical Operations group functions include investigations, deviations, continuous improvement (change controls, CAPAs) operational excellence (major projects), technology transfer support, manufacturing document generation & revision, bill of materials (BOM) management, operations data analytics & metrics, manufacturing finite scheduling and manufacturing suite & readiness. 

This is a full-time on-site position, M-F 8am-5pm

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role:

• Build, lead and manage the MTO group to support on-going and future manufacturing operations ensuring staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines
• Manage the interface of the MTO group with internal stakeholders and clients through proactive communication and accountability for on-time project/work completion; Interacts with clients on projects and presentations; Oversees and coaches team member client interactions
• Oversee daily activity for the group to ensure quality results Performance management for direct reports and drives timely completion of major manufacturing investigations and deviations and subsequent CAPAs
• Oversight and coordination of manufacturing continuous improvement (e.g. CAPAs, Change Controls) and operational excellence activities; establish and manage a yearly slate of improvement projects with measurable results aligned with the site’s objectives
• Supports technology transfer teams led by MS&T providing the manufacturing representative or coordinating manufacturing representation
• Provides effective oversight and coordination of manufacturing document generation & revision, bill of materials (BOM) management, operations data analytics & metrics, manufacturing finite scheduling and manufacturing suite & readiness to ensure timely completion
• Other duties as assigned

The Candidate:

• Masters’ degree in a Scientific, Engineering or Biotech field with 3 years’ experience in cGMP production &/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 6 years’ experience in cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities
• Demonstrable leadership experience at Catalent (including but not limi