Director of Advanced Manufacturing

Overview

This is a strategic leadership role responsible for bridging the gap between R&D innovation and commercial-scale production in new material development involving chemical and gas materials. This position leads the development, scale-up, and technology transfer of novel processes from laboratory discovery through pilot production to full-scale manufacturing, ensuring robust, repeatable, and cost-effective processes that meet quality, safety, and regulatory standards.

• Lead the translation of R&D discoveries and laboratory-scale processes into commercially viable manufacturing operations for new materials, chemicals, and gas-based products.
• Direct process development activities from bench scale through pilot plant to full production scale-up.
• Develop and optimize chemical processes, gas handling systems, material synthesis methods, unit operations, and manufacturing workflows for new and existing products.
• Establish critical process parameters (CPPs), critical quality attributes (CQAs), and process control strategies.
• Design and execute scale-up experiments to validate process robustness and identify potential manufacturing challenges.
• Conduct process risk assessments and implement mitigation strategies during scale-up activities.
• Ensure processes are designed for manufacturability, reliability, and cost-effectiveness across diverse material types.

• Manage seamless technology transfer from Advanced Manufacturing to Operations, ensuring knowledge transfer and process readiness.
• Develop comprehensive process documentation including batch records, standard operating procedures (SOPs), process flow diagrams (PFDs), and piping and instrumentation diagrams (P&IDs).
• Validate that transferred processes are reproducible, scalable, and capable of meeting product specifications.
• Provide technical support during initial production runs and troubleshoot scale-up issues.
• Establish quality specifications, analytical methods, and in-process controls for new materials and products.
• Coordinate cross-functional teams to ensure successful product launches across multiple material platforms.

• Lead advanced manufacturing projects through stage-gate development processes from concept through commercialization.
• Develop project plans, timelines, budgets, and resource requirements for scale-up initiatives.
• Conduct gate reviews and present technical recommendations to senior leadership.
• Manage multiple concurrent projects across different material development programs while prioritizing resources based on business impact.
• Ensure projects meet cost, quality, timeline, and safety objectives.
• Track and report on key project milestones, risks, and deliverables.

• Drive continuous improvement initiatives to enhance process efficiency, yield, quality, and safety across chemical and gas material production.
• Implement process analytical technology (PAT) and advanced process control strategies.
• Develop and maintain process capability studies and statistical process control (SPC) programs.
• Lead root cause analysis and corrective action initiatives for process deviations and quality issues.
• Optimize raw material usage, energy consumption, and waste minimization.
• Implement lean manufacturing and Six Sigma principles in process design.

• Ensure all processes comply with Good Manufacturing Practices (GMP), environmental regulations, and safety standards applicable to chemical and gas materials.
• Support regulatory submissions including process validation protocols, manufacturing sections of regulatory filings, and responses to regulatory inquiries.
• Maintain compliance with FDA, EPA, OSHA, DOT (for gas materials), and other relevant regulatory requirements.
• Lead process validation activities (IQ/OQ/PQ) and ongoing process verification programs.
• Ensure proper documentation and record-keeping to meet audit and inspection requirements.
• Participate in internal and external audits related to manufacturing processes.

• Build, lead, and mentor a team of process engineers, chemical engineers, materials scientists, and technical specialists.
• Foster a culture of innovation, collaboration, continuous improvement, and technical excellence.
• Partner with R&D, Quality Assurance, Quality Control, Operations, Engineering, Supply Chain, and Regulatory Affairs.
• Provide technical guidance and subject matter expertise to support business decisions across multiple material platforms.
• Develop talent through coaching, training, and professional development opportunities.
• Champion safety culture and ensure team adherence to EHS protocols, particularly in gas handling and chemical processing.

• Identify equipment and facility requirements to support process scale-up and technology transfer for chemical and gas material production.
• Develop…