Director, Manufacturing Support

Role Summary

Director, Manufacturing Support will be accountable for lifecycle management, electronic batch records, cleaning and sterilization validation, single-use system implementation and support, process ownership, deviation investigations and corrective actions, and technical training for manufacturing. The leader will direct staff to ensure plant goals are met and represent the manufacturing organization on projects, site and network teams. The role collaborates with cross-functional teams to enable production, deploy new manufacturing technologies, and fulfill the requirements of the Quality Management System.

Responsibilities

• Agile and reliable product lifecycle management
• New technology implementation and digital advancements
• Electronic batch record configuration and maintenance
• Strategy and maintenance of cleaning and sterilization validation programs
• Single use system design, deployment, and defect support
• Process ownership inclusive of deviation investigation, CAPA, change control, and project management
• Finite scheduling of plant operations
• Technical training for manufacturing staff
• Collaborate with cross-functional teams to complete production enabling activities
• Drive continuous improvement initiatives, programs and projects
• Deploy new manufacturing technologies to advance manufacturing strategy
• Ensure that the requirements of the Quality Management System are fulfilled
• Alert senior management of significant quality, compliance, supply and safety risks
• Provide input for management reviews
• Forecast and adhere to a budget for assigned areas

Qualifications

• Required: Bachelor's degree and 10 years of manufacturing experience OR Master’s degree and 8 years of manufacturing experience OR Doctorate degree and 4 years of manufacturing experience
• In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
• Preferred: Currently in a leadership position in a GMP manufacturing plant
• Preferred: Experience in drug substance manufacturing operations for commercially licensed products
• Preferred: Experience with the process validation lifecycle inclusive of process design, process performance qualification, and continued process verification
• Preferred: 6 years managing a team, leading and managing operations
• Preferred: 2 years experience in applying operational excellence and lean manufacturing principles to drug substance manufacturing
• Preferred: Excellent communication and negotiation skills including executive level communication
• Preferred: Experience in a matrixed, cross-site or global network environments

Education

• Bachelor’s degree in a related field with 10 years of manufacturing experience
• Master’s degree in a related field with 8 years of manufacturing experience
• Doctorate degree in a related field with 4 years of manufacturing experience