Senior Scientist I, Analytical Sciences

The role

This individual will lead analytical method development, optimization, qualification, and transfer activities. They will work at the interface of analytical development, process development, formulation, manufacturing, and product characterization to support eRNA and lipid nanoparticle programs.

What you will do

• Lead the development, optimization, qualification, and transfer of analytical methods.
• Design and execute studies to characterize product quality, purity, potency, identity, and concentration.
• Develop phase-appropriate analytical methods and define performance criteria.
• Independently troubleshoot complex analytical and technical challenges.
• Lead investigations of impurities, degradation pathways, and atypical results.
• Collaborate cross-functionally with Process Development, Preclinical Manufacturing, MS&T, and platform teams.
• Evaluate and implement new analytical technologies.
• Author and review analytical procedures, protocols, technical reports, and study summaries.
• Maintain documentation in electronic laboratory notebooks and data management systems.
• Analyze and interpret complex datasets and present findings to stakeholders.

Required qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 3+ years of relevant industry experience; M.S. with 7+ years of relevant industry experience; or B.S. with
• Experience developing, optimizing, qualifying, validating, and transferring analytical methods in a biotechnology or pharmaceutical environment.
• Scientific background in analytical development for biologics, nucleic acid therapeutics, lipid nanoparticles, gene therapies, or other complex therapeutic modalities.
• Hands-on experience with chromatography, capillary electrophoresis, UV-Vis spectroscopy, dynamic light scattering, plate-based assays, ligand-binding assays, molecular biology methods, or cell-based a
• Ability to independently design experiments, analyze complex data, and troubleshoot technical problems.
• Experience supporting product characterization, process development, formulation development, stability studies, specifications, or comparability assessments.
• Understanding of analytical method lifecycle principles.
• Technical writing, data analysis, organizational, presentation, and communication skills.
• Ability to manage multiple priorities and maintain high-quality documentation.
• Ability to work effectively across scientific disciplines and with internal and external partners.

Nice to have

• Experience with RNA analytical characterization, including methods for RNA identity, integrity, purity, concentration, structure, and functional expression.
• Experience with lipid nanoparticle characterization methods, such as particle size, polydispersity, encapsulation efficiency, lipid content, or potency.
• Experience supporting GLP toxicology, clinical manufacturing, stability, or regulatory submission activities, particularly experience with early Phase programs.
• Working knowledge of phase-appropriate GxP requirements and relevant ICH guidance.
• Experience working with CDMOs or contract testing laboratories.
• Experience with statistical analysis and information management tools such as JMP, GraphPad Prism, Benchling, or similar platforms.

About the company

Sail Biomedicines is pioneering the integrative design and deployment of fully programmable medicines to transform patient care. The company was founded by Flagship Pioneering.