6549 - Lead Process Engineer

Lead Process Engineer Responsibilities:

• Serve as a technical SME for API micronization and particle-size reduction processes.
• Develop, optimize, and troubleshoot micronization and milling processes using equipment such as jet mills, Fitz Mills, and cryogenic milling systems.
• Lead or support process development, characterization, scale-up, and technology transfer activities for R&D-stage API programs.
• Evaluate and characterize Particle Size Distribution (PSD) and establish appropriate particle-size targets, ranges, and control strategies.
• Assess the relationship between milling parameters, particle characteristics, material properties, and overall product/process performance.
• Identify and define Critical Process Parameters (CPPs) and relevant Critical Quality Attributes (CQAs) associated with micronization.
• Design and execute studies to improve process understanding, robustness, reproducibility, and scalability.
• Support development of processes suitable for future GMP manufacturing, process validation, PPQ, and commercialization.
• Partner cross-functionally with R&D, Process Development, Manufacturing, Quality, Analytical, Validation, and other technical teams.
• Author and review technical documentation, development reports, protocols, risk assessments, and technology-transfer documentation.
• Troubleshoot milling and particle-size issues and provide technically sound recommendations for process improvement.
• Ensure development activities appropriately consider future regulatory, GMP, validation, and commercial manufacturing requirements.

Requirements:

• Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Mechanical Engineering, or a related scientific/engineering discipline; advanced degree preferred.
• Significant hands-on experience with pharmaceutical API process development and/or manufacturing.
• Demonstrated expertise in micronization and particle-size reduction.
• Hands-on experience with jet milling, Fitz milling, cryogenic milling, or comparable pharmaceutical milling technologies.
• Strong experience with Particle Size Distribution (PSD) characterization, analysis, and interpretation.
• Experience developing and scaling processes from R&D/development through GMP manufacturing.
• Understanding of how milling parameters affect particle size, material characteristics, product performance, process robustness, and manufacturability.
• Experience supporting technology transfer, process validation, PPQ, and/or commercialization readiness.
• Strong knowledge of GMP pharmaceutical manufacturing requirements.
• Ability to lead technical investigations, analyze process data, troubleshoot complex process issues, and communicate recommendations to cross-functional stakeholders.