Principal Engineer, Process Development & Scale-Up

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

Principal Engineer, Process Development & Scale-Up (PR/613281) Boston, Massachusetts

Salary: USD145000 - USD170000 per year

Principal Engineer, Process Development & Scale-Up

Base Salary Range: $145,000-$170,000

Summary

We are currently partnered with a growing life sciences organization developing an innovative combination-product platform.

The organization is seeking a Principal Engineer, Process Development & Scale-Up to lead the development, characterization, optimization, and scale-up of a novel manufacturing process. This individual will play a central role in expanding production capacity, improving product quality, and establishing robust processes for clinical and future commercial manufacturing.

This position is well suited to a hands-on engineering leader who enjoys solving complex manufacturing challenges, developing data-driven process models, and partnering across automation engineering, technical operations, analytical development, and formulation teams.

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 critical process parameters and product quality attributes using first-principles modeling, empirical analysis, and quality-by-design principles.
• Design and execute statistically rigorous experiments to establish operating ranges, improve process robustness, and support manufacturing readiness.
• Analyze complex process datasets and translate findings into practical improvements in throughput, quality, reliability, and cost.
• Partner with automation and equipment engineering teams to evaluate and implement new manufacturing equipment, workflows, process configurations, inspection systems, and process analytical technologies.
• Establish laboratory and pilot-scale processes that support 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, technical documentation, and CMC sections of regulatory submissions.
• Support GMP technical operations and help establish scalable processes suitable for late-phase and commercial manufacturing.
• Manage, mentor, and develop engineers and technical personnel as the manufacturing organization expands.

Qualifications

• Bachelor’s degree or higher in Chemical, Mechanical, Biomedical, Manufacturing Engineering, or a related technical discipline.
• At least 8 years of relevant process engineering or manufacturing process development experience within biopharmaceuticals, medical devices, drug delivery, or combination products.
• Demonstrated success developing, characterizing, and scaling complex manufacturing processes.
• Strong experience with quality by design, design of experiments, statistical analysis, process modeling, and data visualization.
• Hands-on experience working with manufacturing equipment and translating technical findings into practical operational improvements.
• Relevant experience developing or scaling one or more of the following:
• Precision fluid handling or dispensing
• Coating, bonding, drying, or curing processes
• Drug-device combination products
• Automated inspection or assembly
• Process analytical technology
• Other complex or highly controlled manufacturing operations
• Experience using analytical data to evaluate physical or chemical product quality attributes.
• Prior experience supporting GMP technical operations, preferably within late-phase or commercial manufacturing.
• Demonstrated project leadership and prior experience managing engineers or other technical personnel.
• Technology transfer and regulatory submission experience are preferred.