Senior Principal Engineer, Late Stage LNP Process Development

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 

Organization Overview:
At Eli Lilly and Company, we unite caring with discovery to make life better for people around the world. Lilly is a leader in global healthcare and has been discovering and developing medicines that help improve lives for more than 140 years. Our 50,000 employees around the world work as a team to bring breakthrough medicines to patients who need them. We are looking for motivated, highly skilled scientists and engineers to help us continue to bring breakthrough medicines to patients. 

Delivery, Devices, and Connected Solutions (DDCS) sits within Lilly's Product Research & Development organization. We are a diverse team of scientists and engineers responsible for discovering, designing, and developing patient-centric drug delivery solutions across a broad range of modalities — from injection devices to novel routes of administration and nanomedicines. DDCS drives the drug delivery innovation agenda across early and late development to meet the needs of an expanding portfolio that spans small molecules, biologics, and nucleic acid therapeutics. 

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.

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.

Additional Information:

• Position location: Boston, MA
• This position requires in-office/lab presence 5 days/week.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$110,250 - $189,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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