Advisor, Analytical CMC

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.
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* Position Summary:

** The Analytical Development group is responsible for developing and implementing new analytical methods, as well as optimizing and improving current methods for the characterization of raw materials, RNA drug substances, and LNP products and programs at various development stages.

Additionally, the role includes testing non-GMP samples to support development studies such as comparability assessments, process development, stability, product, and process characterization. The position is part of a Technical Operations team that partners closely with Quality Control, Quality Assurance, Process Development, and Analytical Research & Development.
** Responsibilities:
*** Develop, optimize, and execute analytical methods intended for a variety of purposes, including release and stability testing, product characterization, high-throughput analysis, and characterization of complex raw materials.
* Review, interpret, and present data within the analytical team and cross-functional.
* Provide technical oversight for troubleshooting and phase-appropriate qualification and validation of analytical assays for the analysis of gRNA, mRNA, and LNP. Work in partnership with internal and/or external QC to coordinate analytical method transfer within the organization or at Contract Manufacturing Organizations (CMOs)/Contract Testing Laboratories (CTLs).
* Author, review, and revise technical source documents to support phase-appropriate comparability.
* Serve as the CMC representative on cross-functional project teams.
* Provide technical oversight to guide analytical/QC investigations, as needed.
* Actively collaborate with internal and external process development and quality teams.
* Train and mentor junior team members*.
* ** Basic Requirements:
*** PhD in Analytical Chemistry, Biochemistry, Biophysics or related disciplines with 3+ years experience in the Pharmaceutical or Biotech industry.
* 3+ years of experience in LC and CE required
* Strong technical background in assay development, validation and implementation to support target candidate validation from Analytical Development to Internal/external QC environments required
** Additional Skills/Preferences:
*** Will also consider: MS degree with 7+ years of experience OR BS degree with 10+ years of Biotech industry experience.
* Strong hands-on experience using multi-modal HPLC/UPLC LC-fluor, LC-MS, SEC-MALS, spectroscopic (UV/Vis, FTIR), capillary electrophoresis (CE).
* Knowledge of advanced characterization instrumentation such as cryo-TEM, NMR, FFF-MALS, DLS, NTA, AUC etc.
* Working experience developing methods for gRNA, mRNA, and LNPs is a plus.
* Excellent scientific knowledge in analytical chemistry with a conceptual understanding of solid-phase oligonucleotide synthesis and purification strategies.
* Familiarity with applicable ICH regulations and multi-compendial guidelines related to method validation.
* Effective oral and written communication skills.
* Advanced understanding of lipid nanoparticle delivery, production, and purification.
* Proactive, creative, and positive attitude.
* Demonstrated scientific and people leadership skills.

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