Director, Analytical Chemistry Extended Characterization

Eli Lilly and Company•Indianapolis, IN

1d•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 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. We are seeking a Director, Analytical Development, to provide leadership within the Analytical Development team. The individual will lead a team of scientists and associates to develop and implement new and improved analytical methods focusing on extended characterization of RNA drug substances (gRNA and mRNA), and LNP drug products for candidates in late-stage development. The individual and the team will be working closely with cross functional teams within Lilly's Product Research & Development (PRD) organization, leveraging the existing resources and expertise to move forward on Verve programs. Additionally, the team supports testing non-GMP samples to support development studies such as comparability assessments, process development, stability, product and process characterization. The position will be part of a Technical Operations team in Verve that partners closely with Quality Control, Quality Assurance, Process Development and Analytical Research & Development.

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 LNPs and RNA by biophysical techniques such as LC-MS, DSC, DLS, MALS, etc.
Demonstrated competency in operating HPLC/UPLC/LC-MS instrumentation.
Hands-on experience analyzing DNA/RNA by IP-RP, IEX, LC-fluor and multi-modal LC techniques required.
Conceptual understanding of solid phase oligonucleotide synthesis and purification strategies.
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 manage 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.

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.
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 manage 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

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).

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