Advisor - Analytical Development Lead - NGS

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.

Organizational Overview: 

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 work worldwide to discover and deliver 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 individuals determined to make life better for people around the world.

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-functionally.
• 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: 

• MS degree in genetics, biochemistry, or molecular biology and 8+ years industry experience OR PhD with 5+ years industry experience
• Minimum of 5 years of experience in Next-Generation Sequencing (NGS) applications.

Additional Skills/Preferences:

• Highly capable candidate should have proven hands-on experience in qPCR/dPCR/ddPCR, RT-qPCR, NGS, other molecular biology techniques and assays.
• Extensive experience in NGS-based assay development, operating and maintaining NGS instrumentation, analyzing sequencing data using bioinformatics tools.
• Experience in assay development, qualification, validation, and implementation to support target candidate validation from Non-GxP to GMP environments.
• Familiarity with applicable ICH regulations and multi-compendial guidelines related to method validation.
• Knowledge/hands-on experience in oligonucleotide lipid nanoparticle delivery and process development are a plus, but not required.
• Demonstrate experience in supervising and developing junior scientific staff.
• Proactive, creative, ability to work effectively on cross-functional teams and positive attitude.
• Effective oral and written communication skills.

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.