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.
Responsibilities
Process Development & Scale-Up Leadership
• 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
Technology Transfer & Commercialization
• 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
Phase Gate & Project Management
• 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
Manufacturing Process Excellence
• 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
Regulatory Compliance & Quality Systems
• 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
Team Leadership & Cross-Functional Collaboration
• 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
Capital Projects & Infrastructure
• 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
Strategic Planning & Innovation
• 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
• Assess 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
Required
• 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
• Experience with multiple material types including chemical materials, gas-based products, and advanced materials
• Extensive knowledge of Good Manufacturing Practices (GMP) in chemical, materials, or related manufacturing environments
• Strong experience with phase gate/stage gate development processes and project management
• Demonstrated ability to lead cross-functional teams and manage complex technical projects across diverse technology platforms
• Excellent problem-solving, analytical, and decision-making skills
Preferred
• Advanced degree (MS, PhD) in Chemical Engineering, Materials Science, Chemistry, or related field
• Professional Engineer (PE) license
• Six Sigma Black Belt or Master Black Belt certification
• Project Management Professional (PMP) certification
• Experience in multiple regulated industries or applications (pharmaceuticals, electronics, energy, aerospace, etc.)
• Knowledge of process safety management (PSM) and hazard analysis (HAZOP, FMEA) particularly for gas and reactive materials
• Experience with gas purification, compression, storage, and distribution systems
• Background in advanced materials (nanomaterials, composites, specialty chemicals, electronic materials, catalysts, etc.)
• Experience with specialty gases, ultra-high purity materials, or critical material processing
• International manufacturing experience or multi-site project leadership
• Track record of successful regulatory inspections and submissions in relevant industries
Technical Expertise
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
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
