Director of Advanced Manufacturing

Responsibilities

• 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
• Collaborate with 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
• 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 capital project justifications and business cases for manufacturing investments
• Lead or support capital projects including pilot plant expansions, equipment installations, gas handling systems, and facility modifications
• Collaborate with engineering teams on equipment specification, procurement, and commissioning
• Ensure new equipment and facilities meet process requirements and regulatory standards for handling various material types
• Develop and execute advanced manufacturing strategy aligned with business objectives and R&D pipeline across multiple material development programs
• Evaluate emerging technologies and manufacturing innovations applicable to new materials, chemical processes, and gas handling
• Evaluate make-vs-buy decisions and external manufacturing partnership opportunities
• Build manufacturing capabilities and core competencies to support future product portfolio in materials development
• Contribute to intellectual property development through process patents and trade secrets

  Qualifications

  • Bachelor's degree in Chemical Engineering, Materials Science, Chemistry, or related technical discipline
  • 12+ years of progressive experience in process development, materials manufacturing, chemical processing, or related roles with at least 5 years in leadership positions
  • Proven track record of successfully scaling processes from laboratory to commercial production in new materials development
  • Deep understanding of chemical unit operations, gas handling systems, and material synthesis/processing techniques
  • Extensive knowledge of Good Manufacturing Practices (GMP) in chemical, materials, or related manufacturing environments
  • Strong experience with multiple material types including chemical materials, gas-based products, and advanced materials
  • Demonstrated ability to lead cross-functional teams and manage complex technical projects across diverse technology platforms
  • Excellent problem-solving, analytical, and decision-making skills
  • Advanced degree (MS, PhD) in Chemical Engineering, Materials Science, Chemistry, or related field preferred
  • Professional Engineer (PE) license preferred
  • Six Sigma Black Belt or Master Black Belt certification preferred
  • Project Management Professional (PMP) certification preferred
  • Experience in multiple regulated industries or applications (pharmaceuticals, electronics, energy, aerospace, etc.) preferred
  • Knowledge of process safety management (PSM) and hazard analysis (HAZOP, FMEA) particularly for gas and reactive materials preferred
  • Regulatory compliance with FDA, EPA, OSHA, DOT (for gas materials), and other relevant regulatory requirements preferred
  • Experience with gas purification, compression, storage, and distribution systems preferred
  • Background in advanced materials (nanomaterials, composites, specialty chemicals, electronic materials, catalysts, etc.) preferred
  • Experience with specialty gases, ultra-high purity materials, or critical material processing preferred
  • International manufacturing experience or multi-site project leadership preferred
  • Track record of successful regulatory inspections and submissions in relevant industries preferred
  • Materials & Process Knowledge: new material development and characterization, chemical reaction engineering and kinetics, gas purification, separation, and handling technologies, unit operations: distillation, extraction, crystallization, filtration, drying, CVD/PVD processes, material synthesis methods (sol-gel, precipitation, vapor phase, etc.), process thermodynamics and mass/energy balances, batch and continuous processing, catalysis and reaction optimization, gas compression, storage, and distribution systems, containment and purity control strategies, process validation (PV) and continued process verification (CPV), Quality & Regulatory: Process validation (PV) and continued process verification (CPV), Quality by Design (QbD) principles, ICH guidelines (Q8, Q9, Q10, Q11) and industry-specific standards, Risk assessment methodologies (FMEA, HACCP), Regulatory submission requirements across multiple industries, Material specifications and analytical method development, Process Development Tools: Design of Experiments (DOE) and statistical analysis, Process simulation software (Aspen Plus, HYSYS, SuperPro Designer, COMSOL), Computational fluid dynamics (CFD), Process analytical technology (PAT), Material characterization techniques (XRD, SEM, TEM, spectroscopy, etc.), Data analysis tools (JMP, Minitab, Python, MATLAB), Scale-up modeling and dimensionless analysis, Manufacturing Systems: Pilot plant operations and scale-up facilities for diverse materials, Batch manufacturing and automation, Continuous processing and advanced manufacturing techniques, Process control systems (DCS, SCADA, PLC), Equipment sizing and specification for chemical and gas processing, Material handling, containment, and purity maintenance strategies, Cleanroom and controlled environment manufacturing, Safety & Environmental: Process safety management (PSM) for chemical and gas operations, Hazard and operability studies (HAZOP), Gas hazard analysis and emergency response planning, Dust explosion and thermal hazard analysis, Chemical hygiene and occupational exposure limits, Compressed gas safety and cylinder management, Environmental regulations and waste management, Sustainability and green chemistry initiatives, Toxicity and environmental impact assessment for new materials
  • Work Environment: Dynamic laboratory, pilot plant, and manufacturing floor environments involving chemical and gas material processing, Office-based work with significant time in technical areas, Personal protective equipment (PPE) required in manufacturing areas; specialized PPE for gas handling, Exposure to chemical substances and compressed gases requiring proper safety protocols, Work in controlled environments (cleanrooms, inert atmospheres) as required, Occasional domestic and international travel (10-20%) for site visits, conferences, or vendor meetings, Flexibility for project demands and occasional after-hours support