Lead Process Development & Scale-Up Engineer

EPM Scientific; Boston (MA); On-site; USD 145,000 - 170,000; Full time

Job summary

EPM Scientific in Boston, MA is seeking a Principal Engineer, Process Development & Scale-Up to lead development, characterization, optimization, and scale-up of a novel manufacturing process for a combination-product platform.

This hands-on role focuses on expanding production capacity, improving product quality, and establishing robust processes for clinical and future commercial manufacturing, partnering across automation, analytics, and formulation teams.

Qualifications

• Bachelor’s degree or higher in a technical discipline related to manufacturing.
• 8+ years of process engineering or manufacturing development experience in biopharma, devices, or combination products.
• Strong experience with quality by design, DoE, statistics, modeling, and data visualization.
• Hands-on experience with manufacturing equipment and translating findings into operations.

Responsibilities

• Lead process development, characterization, optimization, and manufacturing scale-up for a novel combination-product platform.
• Define and execute risk-based process development strategies supporting early and late-phase programs.
• Develop quantitative relationships between CPPs and PQAs using first-principles modeling, empirical analysis, and QBD principles.
• Design and execute statistically rigorous experiments to establish operating ranges, improve robustness, and support readiness.
• Analyze complex process datasets and translate findings into improvements in throughput, quality, reliability, and cost.
• Partner with automation and equipment engineering teams to evaluate and implement new manufacturing equipment, workflows, configurations, inspection systems, and PAT.
• Establish laboratory and pilot-scale processes for preclinical and clinical manufacturing programs.
• Provide hands-on technical support during equipment commissioning, process troubleshooting, and manufacturing execution.
• Lead technology-transfer activities and contribute to process-development reports and regulatory submissions (CMC).
• Support GMP operations and help establish scalable processes for late-phase and commercial manufacturing.
• Manage, mentor, and develop engineers and technical personnel as the organization grows.

Skills

8+ years process engineering

Hands-on manufacturing experience

Data-driven problem solving

Education

Bachelor’s degree or higher in Chemical, Mechanical, Biomedical, Manufacturing Engineering, or related

Tools

Quality by Design

Design of Experiments

Statistical analysis

Process modeling

Data visualization

Job description

EPM Scientific in Boston, MA is seeking a Principal Engineer, Process Development & Scale-Up to lead development, characterization, optimization, and scale-up of a novel manufacturing process for a combination-product platform.

This hands-on role focuses on expanding production capacity, improving product quality, and establishing robust processes for clinical and future commercial manufacturing, partnering across automation, analytics, and formulation teams.