Principal/Associate Director - CMC & Process Engineering

Commonwealth Science and Technology; Massachusetts; On-site; USD 140,000 - 210,000; Full time

Job summary

Commonwealth Science and Technology seeks a senior process development leader to drive development, optimization, and scale-up of an innovative microarray patch manufacturing platform. You will partner with Automation, Analytical Development, Quality, and other groups to expand capacity while protecting product quality.

Required are 10+ years of leadership in manufacturing process development for pharma/biotech or related fields, strong DoE and data analytics skills, and a proven track record of

Qualifications

• Bachelor's degree or higher in Mechanical, Chemical, Biomedical, Manufacturing, or related engineering.
• 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.

Responsibilities

• Lead process development, optimization, and scale-up activities from early development through commercial readiness.
• Establish strategies for increasing capacity and throughput while maintaining product quality and process capability.
• Apply engineering fundamentals and data-driven methods to understand critical process parameters and their impact on quality.
• Develop and utilize models to characterize processes and support scale-up decisions.
• Design and interpret DoEs to identify drivers, establish operating ranges, and resolve manufacturing issues.
• Collaborate with cross-functional groups to implement robust manufacturing solutions.
• Evaluate new equipment, automation, and methods to support future capabilities.
• Lead investigations and troubleshooting for process, equipment, material, and performance issues.
• Develop approaches for analyzing large datasets to translate findings into improvements.
• Establish relationships between process conditions, quality attributes, and performance; support tech transfer and regulatory submissions.

Skills

Process development

Scale-up experience

DoE

Statistical analysis

Data-driven optimization

Technical leadership

Mentoring

Cross-functional collaboration

Manufacturing optimization

Education

Bachelor's degree or higher in Mechanical, Chemical, Biomedical, Manufacturing, or related engineering

Job description

• 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.