Advisor - LNP Process Development

Eli Lilly and Company • Boston, MA

2d

About The Position

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.

Requirements

• 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

Nice To Haves

• Demonstrated expertise in lipid nanoparticle formulation across multiple mixing platforms (NanoAssemblr, 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

Responsibilities

• 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

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Ph.D. or professional degree