Advisor - Molecular Biology, Analytical Development - BR&D

About the role

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.

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.

Qualifications

• Ph.D. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 0-5+ years of relevant pharmaceutical or biotech industry experience;
• M.S. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 6+ years of relevant pharmaceutical or biotech industry experience;
• 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.