Senior Principal Engineer, Late Stage LNP Process Development

Lilly • Boston, MA

3d • $110,250 - $189,200 • Onsite

About The Position

Eli Lilly and Company is seeking an experienced LNP Process Development Engineer to join its Late Stage LNP Process Development Team within Delivery, Devices, and Connected Solutions (DDCS), part of Product Research & Development. The team develops lipid nanoparticle processes to support late-stage manufacturing readiness and drug product process characterization.

This lab-facing role advances LNP process development by characterizing key unit operations, especially high-pressure mixing technologies and tangential flow filtration (TFF). The engineer will lead and support process characterization studies, collaborate with cross-functional teams, contribute to Phase 3 process lock, and support technology transfer and manufacturing readiness activities. The position is based in Boston, Massachusetts, and requires in-office and laboratory presence five days per week.

Requirements

• Bachelor’s degree in a relevant scientific discipline, such as Chemical Engineering, Biomedical Engineering, or Biotechnology, or equivalent.
• At least 6 years of biotech or pharmaceutical industry experience in LNP formulation and/or process development.
• Hands-on experience with LNP unit operations such as TFF, high-pressure mixing, filtration, and lipid solubilization.
• Experience using statistical software, preferably JMP, to analyze and trend large amounts of data.
• Ability to analyze and use data to guide future studies and author reports.
• Strong oral and written communication skills and the ability to thrive in a team-oriented, goal-driven environment.
• Strong interpersonal skills for collaboration.
• Ability to prioritize multiple activities and handle ambiguity.

Nice To Haves

• Master’s degree in a relevant scientific discipline, such as Chemical Engineering, Biomedical Engineering, or Biotechnology, or equivalent.
• Experience with process characterization.

Responsibilities

• Perform design-of-experiments (DoE)-type studies to support process characterization, identify critical process parameters (CPPs), and characterize normal operating ranges (NORs) and process acceptable ranges (PARs) for parameters in each unit operation.
• Lead the design and execution of process development studies to support scale-up and locking of late-stage LNP processes.
• Support technology transfers of late-stage programs to manufacturing sites and contribute to batch readiness activities and technical investigations as required.
• Author process development and characterization reports and support authoring regulatory documents as needed.
• Participate in technical discussions and meetings and proactively communicate technical findings and results to stakeholders.
• Keep laboratory notebooks updated and support equipment troubleshooting and maintenance as needed.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior