Advisor, Analytical Development-CMC (Cell and Molecular Biology)

Eli Lilly and Company • Indianapolis, IN

2d • Onsite

About The Position

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, Analytical Research & Development, and other teams.

Requirements

• PhD in Molecular Biology, Cell Biology, Biochemistry, Microbiology or a related field, with 5+ years of experience in biotech/pharmaceutical industry, specifically in cell-based assay development. OR MS in Molecular Biology, Cell Biology, Biochemistry, Microbiology or a related field, with 10+ years of experience in biotech/pharmaceutical industry, specifically in cell-based assay development.
• Hands-on experience developing and troubleshooting molecular and cell-based analytical methods applied to complex and heterogeneous systems.
• Excellent scientific knowledge in biochemistry, cell biology and molecular biology with a conceptual understanding of strategies for method development and troubleshooting.
• 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.
• Proactive, creative, ability to work effectively on cross-functional teams and positive attitude.
• Effective oral and written communication skills.
• Proven people leadership skills.

Nice To Haves

• Experience in developing cell-based potency assays is highly preferred.
• Advanced understanding of lipid nanoparticle delivery, production, and purification is a plus.
• Knowledge/hands-on experience in automation and liquid handlers are desirable but not required.

Responsibilities

• Lead the development, optimization and qualification of analytical methods intended for a variety of purposes, including release and stability testing, product characterization, high-throughput analysis, and characterization of complex raw materials.
• Partner across the Analytical Development team and cross-functionally with BR&D and SMDD to lead, plan, and execute complex 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.
• 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).
• Provide technical oversight for troubleshooting and phase-appropriate qualification and validation of analytical assays for the analysis of gRNA, mRNA, and LNP.
• Review, interpret, and present data within the analytical team and cross-functionally.
• 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 manufacturing and analytical/QC investigations, as needed.
• Train and mentor junior team members.
• Other duties as assigned.

Benefits

• company bonus (depending, in part, on company and individual performance)
• 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
• 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: Senior
• Education Level: Ph.D. or professional degree