Advisor - Molecular Biology, Analytical Development - BR&D

Eli Lilly and Company • Us, IN

2d • Onsite

About The Position

The BRD Analytical Development team is seeking an Advisor to support analytical development for genetic medicines and advanced therapy medicinal products (ATMPs). This role is primarily laboratory-based, with responsibility for developing and qualifying analytical methods that characterize drug substance and drug product quality attributes across the genetic medicines portfolio, spanning early-phase IND-enabling studies through commercial BLA readiness. The successful candidate will have practical expertise in molecular biology and nucleic acid analytics and will contribute to GMP analytical activities within a cross-functional CMC development environment.

Requirements

• Ph.D. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 0-5+ years of relevant pharmaceutical or biotech industry experience; or M.S. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 6+ years of relevant pharmaceutical or biotech industry experience; or B.S. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 12+ years of relevant pharmaceutical or biotech industry experience.
• Practical proficiency with qPCR and/or ddPCR/dPCR for quantitative nucleic acid analysis in a pharmaceutical or biotech development context.
• Practical proficiency with immunoassay platforms (ELISA and/or related technologies) for quantitative analysis of process-related impurities or product quality attributes in a pharmaceutical or biotech development context.
• Hands-on experience with molecular biology techniques (gel electrophoresis, blotting, restriction analysis) applied to biopharmaceutical or genetic medicine characterization.
• Demonstrated ability to independently design experiments, generate high-quality data, and interpret results in a development environment.
• Familiarity with GMP/GLP requirements and their application to analytical method development and documentation.

Nice To Haves

• Experience with viral vector (AAV, LVV) or cell therapy analytical programs, including genome integrity, residual DNA, and encapsidation efficiency assessments.
• Familiarity with NGS workflows (library preparation, sequencing, bioinformatic interpretation) as an orthogonal characterization approach for genetic medicine products.
• Knowledge of FDA/EMA regulatory expectations for nucleic acid-based CQA testing in genetic medicine CMC submissions.
• Experience supporting analytical aspects of IND or BLA/MAA submissions, including contributing to Module 3 analytical sections.
• Experience with method transfer to external CRO/CMO organizations and participation in inter-laboratory comparability studies.
• Proficiency with electronic laboratory notebooks (e.g., Benchling) and data management systems.
• Effective oral and written communication skills; ability to present complex technical information to multidisciplinary audiences.
• Demonstrated ability to manage multiple priorities and work productively in a fast-paced, collaborative team environment.

Responsibilities

• Develop, qualify, and execute PCR-based methods (qPCR, ddPCR/dPCR) for viral vector genome titration, residual DNA quantitation, and related nucleic acid analytes in support of genetic medicine programs.
• Experience with immunoassay platforms (ELISA, MSD, Gyrolab) for residual host cell protein or impurity testing.
• Apply molecular biology techniques including 1- and 2-D gel electrophoresis, blotting, and restriction enzyme analysis for product characterization.
• Contribute to analytical control strategies for genetic medicine drug substance and drug product, including identification of critical quality attributes (CQAs) and appropriate test methods.
• Support assay qualification, verification, and validation activities per ICH Q2(R2) and applicable regulatory expectations for genetic medicine and ATMP products.
• Contribute analytical data and technical content supporting stability study design and execution across DS and DP matrices.
• Ensure all analytical work is conducted in compliance with GMP, GLP, and applicable HSE requirements; maintain awareness of internal quality procedures and regulatory expectations.
• Author and review analytical methods, protocols, qualification/validation reports, method transfer packages, and technical summaries with high scientific accuracy and clarity.
• Maintain rigorous electronic laboratory notebook (ELN) practices and documentation standards for all experimental records.
• Support technology transfer of analytical methods to CRO/CMO partners and Lilly manufacturing sites; participate in cross-site qualification or co-validation studies.
• Provide technical input during interactions with external analytical partners; review and interpret externally generated data packages.
• Maintain awareness of emerging analytical technologies, regulatory guidance updates, and industry best practices relevant to genetic medicine analytical development.
• Collaborate within cross-functional project teams including process development, quality, regulatory affairs, and clinical operations to deliver analytical support for clinical trials and regulatory submissions.
• Communicate analytical results, timelines, and technical challenges clearly to team members and project stakeholders in oral and written formats.
• Contribute to a positive, inclusive, and scientifically rigorous team culture; share technical knowledge and support the growth of colleagues.

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