Head of Manufacturing Support

Role Summary

Head of Manufacturing Support responsible for leading the Manufacturing Compliance, Training, Project Management, and Operations Support teams. Oversees development and execution of support team strategies to assist internal manufacturing operations, ensuring compliant delivery of the plan of record, including technology transfers and new product introductions, and driving continuous improvement within 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 expert (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

• Strategic thinking
• cGMP and regulatory compliance
• Training and development
• Project management
• Operations support
• Quality systems management
• Cross-functional collaboration

Education

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