Advisor - Analytical Development 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.

Organization Overview: 

Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines.

At Eli Lilly & Company, 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.

Analytical Development-CMC in Verve is a diverse team of analytical chemists, molecular biologists and pharmaceutical scientists delivering product and process understanding to the LNP-gene therapy systems. Ideal candidates will possess experience across multiple analytical techniques, demonstrate an aptitude in technical problem solving, and be motivated to work both independently and collaboratively in a dynamic environment.

Responsibilities:

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.

• 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 of Biotech/pharmaceutical industry experience in Analytical Development OR MS degree in Analytical Chemistry, Biochemistry, Biophysics or related disciplines with 7+ years of Biotech/pharmaceutical industry experience in Analytical of experience

• Minimum 3+ years of experience in LC and CE

Additional Skills/Preferences:

• Strong technical background on analytical methodologies using CE and HPLC.

• Hands-on experience developing, qualifying and troubleshooting biophysical assays using IP-RP, IEX, LC-fluor, LC-MS, SEC-MALS multi-modal HPLC/UPLC, spectroscopic (MS, UV/Vis, FTIR), capillary electrophoresis (CE).

• Experience in assay validation and implementation to support target candidate validation from non-GxP to GMP environments.

• Strong technical background on advanced characterization instrumentation such as cryo-TEM, NMR, FFF-MALS, DLS, NTA, AUC etc.

• Experience developing methods for gRNA, mRNA, and LNPs.

• Excellent scientific knowledge in analytical chemistry with a conceptual understanding of solid-phase oligonucleotide synthesis and purification strategies.

• Advanced understanding of lipid nanoparticle delivery, production, and purification.

• Familiarity with applicable ICH regulations and multi-compendial guidelines related to method validation.

• Proactive, creative, and positive attitude.

• Effective oral and written communication skills.

• Demonstrated scientific and people leadership skills.

• Management experience preferred.

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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, experience, skills, and geographic location.  The anticipated wage for this position is

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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly