Advisor, Analytical Separations & Biochemistry, Analytical Development - BR&D

Position Overview

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 for characterization, release, and stability testing of drug substance and drug product across the genetic medicines portfolio, spanning early‑phase IND‑enabling studies through commercial BLA readiness. The successful candidate will have deep hands‑on expertise in chromatographic and electrophoretic separations and will contribute to GMP analytical activities within a cross‑functional CMC development environment.

• Design, develop, optimize, and execute chromatographic separations methods including anion‑exchange (AEX/IEX), size‑exclusion chromatography (SEC), and ion‑pairing reversed‑phase HPLC (IP‑RP‑HPLC) for purity, integrity, and quality attribute assessment of genetic medicine drug substance and drug product.
• Develop and execute capillary electrophoresis methods (CE‑SDS, cIEF) for size‑ and charge‑based characterization of drug substance components.
• Develop, qualify, and validate robust analytical methods for the identification and quantitation of process‑related residual impurities in support of product quality and regulatory requirements.
• Apply separations‑based techniques to support DS and DP release, characterization, and stability programs across genetic medicine modalities.
• Troubleshoot chromatographic and electrophoretic method performance issues including resolution, peak shape, carryover, and reproducibility, and implement appropriate corrective strategies.
• Evaluate and implement fit‑for‑purpose separations technologies to advance the analytical control strategy for genetic medicine programs.
• 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 12+ years…