Senior Principal Engineer, Late Stage LNP Process Development
Eli Lilly and Company
Summary
We are seeking an experienced LNP Process Development Engineer to join the Late Stage LNP Process Development Team. You will be joining a team that is focused on the development of LNP processes to support late-stage manufacturing readiness activities and drug product process characterization.
Job description
This lab-facing role will play a critical part in advancing lipid nanoparticle (LNP) process development through characterization of key unit operations, with particular emphasis on high-pressure mixing technologies and tangential flow filtration (TFF). The ideal candidate will combine technical expertise with collaborative skills to lead and support process characterization studies and work closely with cross-functional teams. The role will also contribute towards Phase 3 process lock and supporting tech transfer and manufacturing readiness activities.
Responsibilities
- Perform DoE-type studies to support process characterization efforts in order to identify critical process parameters (CPPs) and characterize appropriate normal operating ranges (NORs) and process acceptable ranges (PARs) for each parameter in each unit operation.
- Lead the design and execution of process development studies to contribute towards scaling-up and locking late stage LNP processes.
- Support technology transfers of late-stage programs to manufacturing sites and contribute towards batch readiness activities and technical investigations as required.
- Author relevant process development and characterization reports and provide support as required in authoring regulatory documents.
- Participate actively in technical discussions and meetings, proactively communicate technical findings and results to stakeholders.
- Ensure lab notebooks are kept updated and support equipment troubleshooting and maintenance as needed.
Basic Requirements
- Earned Bachelor’s degree in a relevant scientific discipline (Chemical Engineering, Biomedical Engineering, Biotechnology, or equivalent)
- 6+ years of biotech/pharmaceutical industry experience within 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 use analyze and use data to guide future studies and when authoring reports.
- Strong communication skills (oral and written) and the ability to thrive in a team and goal-driven environment.
- Use of strong interpersonal skills for collaboration.
- Ability to prioritize multiple activities and handle ambiguity.
Additional Skills/Preferences
- Earned Master's degree in a relevant scientific discipline (Chemical Engineering, Biomedical Engineering, Biotechnology, or equivalent)
- Experience with process characterization is strongly preferred.
Requirements
- Earned Bachelor’s degree in a relevant scientific discipline (Chemical Engineering, Biomedical Engineering, Biotechnology, or equivalent)
- 6+ years of biotech/pharmaceutical industry experience within 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 use analyze and use data to guide future studies and when authoring reports
- Strong communication skills (oral and written) and the ability to thrive in a team and goal-driven environment
- Use of strong interpersonal skills for collaboration
- Ability to prioritize multiple activities and handle ambiguity
- Earned Master's degree in a relevant scientific discipline (Chemical Engineering, Biomedical Engineering, Biotechnology, or equivalent)
- Experience with process characterization is strongly preferred
Benefits
- 401(k)
- Pension
- Vacation benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Prescription drug benefits
- Flexible spending accounts
- Life insurance
- Death benefits
- Employee assistance program
- Fitness benefits
- Employee clubs and activities
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.