Advisor - LNP Process Development

Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

We are seeking an Advisor - LNP PD to join our team in Boston, MA. Come join the rapidly expanding Eli Lilly Gene Therapy Team! We are responsible for inventing, characterizing, and advancing novel gene therapy reagents for a myriad of clinical applications. Our team works cross-functionally within our organization across multiple disease areas and platforms. Our goal is to deliver on the promise of gene therapy to patients around the world.

This role may require up to 10-15% travel for conferences or training and will include the opportunity to mentor and train two junior scientists.

• Lead the design, execution, and interpretation of complex process development studies for TNP and LNP formulations
• Drive innovation in LNP/TNP manufacturing processes, including evaluation and implementation of emerging technologies and platform approaches
• Establish process understanding through systematic characterization of critical process parameters (CPPs) and critical quality attributes (CQAs)
• Develop scalable manufacturing processes from bench-scale through preclinical development, ensuring robust technology transfer
• Lead protocol development and author comprehensive technical reports supporting regulatory filings
• Ensure GXP compliance and maintain rigorous documentation practices in electronic lab notebooks

• PhD in Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related fields with 0-3+ years of industrial experience
• OR Master's degree with 8-10+ years of relevant industrial experience in LNP/nanoparticle formulation development

• Demonstrated expertise in lipid nanoparticle formulation across multiple mixing platforms (Nano Assemblr, T-mixing, IJM, staggered herringbone mixers, etc)
• Deep understanding of downstream processing including tangential flow filtration (TFF), buffer exchange, and sterile filtration
• Advanced knowledge of nanoparticle characterization techniques: DLS, ELS, cryo-TEM, LC-MS/MS, HPLC-CAD, Ribogreen assays, encapsulation efficiency methodologies
• Strong foundation in process development principles including scale-up considerations, process validation concepts, and risk assessment
• Have experience working with CDMOs for tech transfer and batch production

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 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education,…