Director, Analytical Chemistry Extended Characterization

Eli Lilly and Company • Indianapolis, IN

1d • $148,500 - $257,400 • Onsite

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. 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 motivated individuals who are determined to make life better for people around the world. Verve Therapeutics is a wholly owned subsidiary of Lilly. Verve is a biotechnology company created with a singular focus: to protect the world from heart disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, the company aims to develop transformative, once-and-done therapies for coronary heart disease. Verve’s gene editing medicines are designed to safely edit the genome of adults and mimic naturally occurring gene variants to permanently lower LDL cholesterol and triglyceride levels. This is a rare and exciting opportunity to build something from the ground up. We are seeking a Director, Analytical Development to serve as a leader within Verve's Analytical Development function. This is not a role where you inherit a team and maintain the status quo — you will recruit, shape, and lead a team of scientists and associates, building the analytical capabilities that will power Verve's late-stage pipeline from the inside out. You will architect and implement next-generation analytical methods for the extended characterization of RNA drug substances (gRNA and mRNA) and LNP drug products, driving programs from development through commercialization. You'll operate at the intersection of science and strategy, working hand-in-hand with cross-functional teams across Lilly's Product Research & Development (PRD) organization — leveraging world-class resources and expertise to accelerate Verve's programs. Your team will also support non-GMP testing across development studies including comparability assessments, process development, stability, and product and process characterization. As part of Verve's Technical Operations team, you will be a key partner to Quality Control, Quality Assurance, Process Development, and Analytical Research & Development — with real influence over how this function is built and where it goes. If you're a scientifically driven leader who thrives on building, solving hard problems, and making a meaningful impact on human health, this is the role for you!

Requirements

• PhD in analytical chemistry or bioanalytical chemistry, or a related field with 10+ years of experience in the pharmaceutical industry
• Prior laboratory operations and management experience leading a team of scientists and associates for analytical development in a clinical stage biotech environment.
• Prior experience must include performing analytical assays to support the development of lead molecules, troubleshooting and optimizing analytical assays for GMP use per ICH guidelines.
• Experience with planning and executing product and process development studies such as forced degradation, comparability assessments, stability, extended characterization, etc.
• Experience with analytical control strategy implementation, and/or regulatory submissions related to advanced gene therapies.
• Direct experience analyzing molecules (LNPs and RNA preferred) by biophysical techniques such as LC-MS, DSC, DLS, MALS, etc.
• Hands-on experience analyzing molecules (DNA/RNA preferred) by IP-RP, IEX, LC-fluor and multi-modal LC techniques.
• Experience with technical transfer of analytical methods into manufacturing operations.
• Experience developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets.
• Demonstrated success in persuasion, influence, and negotiation.
• Good interpersonal skills and a sustained tendency for collaboration.
• Ability to prioritize multiple activities and handle ambiguity.
• Ability to influence others to promote a positive work environment.
• Demonstrated technical proficiency and ability to create ideas for future work plans.

Nice To Haves

• Knowledge/hands-on experience in oligonucleotide lipid nanoparticle delivery, production and purification of short and large oligonucleotides, protein engineering and process development are a plus, but not required.
• Conceptual understanding of solid phase oligonucleotide synthesis and purification strategies.

Responsibilities

• Lead a team of scientists working on mRNA, gRNA and LNP assays focused on biophysical extended characterization.
• Partner across the Analytical Development team and cross-functionally with BR&D and SMDD to lead, plan, and execute complex characterization studies; serve as the analytical lead in cross-functional interactions.
• Develop and implement methods intended for product characterization to support late stage and commercialization of gene editing programs.
• Provide technical expertise for the structural characterization of gRNAs, mRNAs and lipid nanoparticle (LNP) complexes.
• Serve as analytical lead for CMC project teams and other VPT teams.
• Oversee troubleshooting, tech transfer, and phase-appropriate GMP validation of analytical methods at the internal Quality Control lab and at contract testing labs in collaboration with Quality team.
• Author and review technical reports and regulatory submissions.
• Provide guidance and support to team members, promoting their professional growth and development.
• Effectively run multiple projects to ensure timely delivery.
• Foster a culture of lab safety, data integrity, collaboration, innovation, continuous improvement and accountability within the team.
• Other duties as assigned.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• 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: Director
• Education Level: Ph.D. or professional degree