Director of Advanced Manufacturing

Job Description

Job Description

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