Advisor - Molecular Biology, Analytical Development - BR&D

Advisor, Brd Analytical Development

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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.

• 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.

• 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…