Head of Manufacturing Support

Role Summary

As the Head of Manufacturing Support, you will be responsible for leading the Manufacturing Compliance, Training, Project Management, and Operations Support teams. This role oversees the development and execution of support team strategies, ensuring effective assistance to internal manufacturing operations. You will enable consistent and compliant delivery of the plan of record, which includes technology transfers and new product introductions, drives continuous improvement within Manufacturing, and supports the realization of the overall manufacturing strategy. You will report into the Head of Manufacturing.

Responsibilities

• Develop a comprehensive manufacturing support strategy to ensure safe, compliant and efficient MFG operations
• Deliver a high level of customer service for the MFG Operations team
• Lead team subject matter expertise (SME) for cGMP Manufacturing operations, technical training, investigations, quality systems management, and project support
• Develop MFG Training strategy to ensure flexibility and redundancy within Manufacturing operations
• Caching/training of Manufacturing Support Staff
• Promote internal inspection readiness of the Manufacturing Teams
• Facilitation and continuous improvement of management systems, including development and monitoring of metrics intended to drive business process improvements
• Liaise between manufacturing and cross-functional areas as applicable
• Drive the organization towards a culture of innovation, collaboration, best practice, accountability, and efficiency

Qualifications

• Bachelor's degree or equivalent experience in Engineering or Science and 15+ years of relevant experience in commercial biotechnology or pharmaceutical production
• Strong knowledge of cGMP and other regulatory requirements related to manufacturing biologics
• Ability to think strategically and realize support vision in line with overall manufacturing mission and vision
• Capable of making technically sound and compliant recommendations regarding cGMP operations
• Organizational effectiveness and employee development focus
• Actively seeks ways to improve current systems and processes related to manufacturing and individual activities
• Proactively and systematically seeks and applies best practices for and gap identification
• Understanding of company business, objectives, and operations and how own activities fit within company strategy
• MS Office, LIMS, SAP, TrackWise, EDMS, compliance, and strong scientific understanding

Skills

• MS Office
• LIMS
• SAP
• TrackWise
• EDMS
• Compliance
• Strong scientific understanding

Education

• Bachelor's degree or equivalent experience in Engineering or Science