Principal Process Development & Scale-Up Leader

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

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