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