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.

Responsibilities

• 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

Qualifications

• 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 and/or quantitative), including method development and data interpretation for complex matrices
• Preferred: LNP characterization experience — Experience with DLS and interpretation of size/PDI trends; familiarity with other LNP-relevant techniques (e.g., zeta potential, particle concentration, cryo/TEM collaborations, DSC, spectroscopy, or other orthogonal tools depending on platform needs)
• Preferred: Drug development and CMC mindset — Experience developing analytical assays in a fast-paced, flexible CMC environment, using phase-appropriate qualification and validation strategies; ability to stay current with evolving regulatory guidance
• Preferred: Regulatory document writing — Demonstrated ability to author technical documentation and contribute to regulatory submissions, and to respond to Health Authority questions with clear scientific justification
• Preferred: Bioanalysis experience — LC-MS experience supporting preclinical bioanalysis (e.g., exposure/PK, tissue distribution, or related studies), including sample prep and quantitative workflows
• Preferred: Ways of working — Demonstrated productivity and strong track record of delivery in a matrixed, fast-paced environment; excellent written and verbal communication skills; ability to influence cross-functional stakeholders and mentor others