Principal/Associate Director - CMC & Process Engineering

Position located in Boston, MA

Responsibilities:

• Lead process development, optimization, and scale-up activities for an innovative microarray patch manufacturing platform from early development through commercial readiness.
• Establish technical strategies for increasing manufacturing capacity and throughput while maintaining or improving product quality, process capability, and consistency.
• Apply engineering fundamentals, statistical methods, and data-driven approaches to understand and optimize critical process parameters and their impact on product quality.
• Develop and utilize first-principles, empirical, and statistical models to characterize manufacturing processes and support scale-up decisions.
• Design, execute, and interpret statistically based experiments (DoEs) to identify process drivers, establish operating ranges, and resolve complex manufacturing issues.
• Partner closely with Automation, Technical Operations, Analytical Development, Formulation, Quality, and other cross-functional groups to develop and implement robust manufacturing solutions.
• Evaluate new equipment, automation technologies, process configurations, analytical methods, and process analytical technologies to support future manufacturing capabilities.
• Lead technical investigations and troubleshooting efforts involving complex process, equipment, material, and product-performance issues.
• Develop approaches for analyzing large and complex process datasets and translate findings into actionable process improvements.
• Establish quantitative relationships between process conditions, critical quality attributes, and overall process performance.
• Support technology transfer, process validation, manufacturing readiness, and scale-up activities as programs progress toward later-stage development and commercialization.
• Ensure process development activities are appropriately documented and provide technical content for CMC documentation and regulatory submissions.
• Operate within a GMP-regulated environment and ensure process development activities are aligned with applicable quality and regulatory requirements.
• Provide technical leadership to engineers and technicians, including mentoring, coaching, project direction, and development of team capabilities.
• Depending on level, directly manage a team of process engineers and technical personnel and help establish the organization's long-term engineering capabilities.
• Work effectively in a fast-paced development environment where priorities, technologies, and manufacturing strategies may evolve rapidly.
• Drive continuous improvement initiatives and identify opportunities to improve process robustness, efficiency, scalability, and manufacturing reliability.

Requirements:

• Bachelor's degree or higher in Mechanical, Chemical, Biomedical, Manufacturing, or a related engineering discipline.
• 10+ years of relevant experience with demonstrated technical leadership and experience managing engineers or other technical professionals.
• Demonstrated experience developing, optimizing, and scaling manufacturing processes within pharmaceutical, biotechnology, medical device, drug delivery, or combination-product environments.
• Strong understanding of engineering fundamentals and demonstrated ability to apply them to complex manufacturing processes.
• Extensive hands-on experience with Design of Experiments (DoE), statistical analysis, process characterization, and data-driven process optimization.
• Experience developing quantitative models or other analytical approaches to understand relationships between process parameters and product quality.
• Experience with one or more of the following is highly desirable: microscale manufacturing, drug delivery systems, precision fluid dispensing, coating, bonding, drying/curing, automated assembly, automated inspection, or other highly automated manufacturing processes.