Sr Scientist, Analytical Development

Role Summary

Role:
Sr Scientist, Analytical Development. We are seeking a motivated scientific/technical leader to develop analytical and QC-ready methods for lipid nanoparticle (LNP) formulated Prime Editor drug products (DP). This role combines strategy with hands-on method development to support development from early formulation through clinical stages. The successful candidate will develop, qualify, and validate analytical methods for DP release and stability testing, in-process control and characterization, with a strong emphasis on lipids, LC-MS, and LNP biophysical analytics.

Excellent technical writing and regulatory documentation experience are strongly preferred; bioanalysis experience is a plus.

• Develop strategic plans and drive execution of analytical development activities for LNP DP programs, in alignment with program strategies
• Contribute to the development and refinement of the analytical control strategy, aligned with QTPP/CQAs and stage-appropriate development needs (early to late phase).
• Identify assay gaps, establish fit-for-purpose methods, and drive assay readiness for technology transfer and/or validation.
• Apply understanding of LNP drug product–specific CQAs—including particle size/PDI, encapsulation efficiency, lipid and RNA composition, impurities and degradants, and stability-indicating attributes—to inform analytical strategy, method development, and control approaches.
• Develop and implement separation-based methods for LNP analytical characterization and lipid analytics
• Develop/optimize HPLC/UPLC/LC-MS methods for lipid components, impurities, degradants, and formulation-related analytes
• Support assays for lipid identity/composition, residuals, and stability-indicating methods, as appropriate
• Design and interpret forced degradation studies; support impurity/degradant identification; and evaluate stability trends to support control strategy and product understanding
• Advance, optimize, and maintain chromatographic and/or electrophoretic methods for RNA analysis
• Support biophysical characterization and orthogonal analytics for LNPs
• Develop/optimize DLS methods (particle size, PDI) and support complementary biophysical characterization techniques (e.g., zeta potential, particle concentration, morphology)
• Interpret characterization data in the context of formulation/process changes, stability, and comparability
• Regulatory documentation and inspection readiness
• Author, review, and approve protocols, SOPs, method reports, validation/verification documents, and CMC sections for regulatory submissions
• Prepare written responses to regulatory information requests and support Health Authority interactions
• Support DP release and stability testing, comparability evaluations, and technology transfer activities, as appropriate for development stage
• Support in-house and external DP release and stability testing activities
• Provide technical oversight for external testing at CDMOs/CROs, ensure method performance, and review external data packages
• Cross-functional collaboration and scientific communication
• Partner cross-functionally and communicate data, risks, and recommendations clearly
• Data integrity and documentation excellence
• Maintain detailed and complete records in electronic lab notebooks and associated systems; ensure data integrity, traceability, and alignment with GxP expectations as programs progress
• Contribute to continuous improvement of analytical workflows, LIMS/ELN utilization, and laboratory best practices

• Required:
  
  Education/Experience — PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related discipline with a minimum of 3 years of relevant industry experience; or BS/MS with 10+ years of relevant industry experience
• Preferred:
  Core technical expertise — Strong chemistry background, ideally with experience in lipids, lipid excipients, or related small-molecule chemistry
• Preferred:
  Core technical expertise — Deep hands‑on experience with HPLC/UPLC method development (including troubleshooting, robustness, and stability‑indicating methods)
• Preferred:
  Core technical expertise — Strong experience with LC‑MS (qualitative…