Principal Engineer, Process Development & Scale-Up
Principal Engineer, Process Development & Scale-Up
Location: Greater Boston Area
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.