Advisor, Analytical Separations & Biochemistry, 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 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.

Responsibilities

• 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.

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.

Demonstrated hands-on laboratory proficiency with HPLC/UHPLC platforms and chromatographic separations (AEX/IEX, SEC, IP-RP-HPLC) applied to biopharmaceutical drug substance or nucleic acid analytes in a pharmaceutical or biotech development context.

Practical experience with capillary electrophoresis platforms (CE-SDS and/or cIEF) for biopharmaceutical characterization in a pharmaceutical or biotech development context.

Experience with method development, optimization, and qualification/validation of separations-based methods in a pharmaceutical or biotech development context.

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.

Additional Skills & Preferences

• Experience applying separations methods to genetic medicine or ATMP products, including viral vector purity profiling, empty/full capsid ratio assessment, or nucleic acid payload characterization.
• Familiarity with orthogonal characterization platforms such as flow cytometry or mass spectrometry for genetic medicine product analysis.
• Knowledge of FDA/EMA regulatory expectations for separations-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 immunoassay platforms (ELISA, MSD, Gyrolab) for residual host cell protein or impurity testing.
• 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.