Scientist/Senior Scientist, RNA Analytical Development

Key Responsibilities

• Develop and execute a phase-appropriate analytical characterization strategy for raw materials (e.g., novel lipids, targeting ligands, pDNA), drug substances (e.g., mRNA, ASO, siRNA, gRNA), and drug products (e.g., LNP, conjugated oligonucleotides).
• Select and implement phase-appropriate analytical workflows for RNA raw materials, DS, DP using orthogonal techniques (e.g., HPLC, LC-MS, CE, UV spectroscopy, qPCR, DLS, TEM) to support platform development and pipeline programs.
• Apply Quality by Design (QbD) principles to define critical quality attributes (CQAs) and ensure method robustness, scalability, and phase-appropriate throughput.
• Collaborate with cross-functional project teams to align analytical strategies with product development goals.
• Develop and maintain SOPs, method validation plans, and analytical documentation in compliance with industry standards and regulatory expectations.
• Maintain accurate records using LIMS/ELN systems to support data integrity and reproducibility.
• Prepare technical reports, presentations, and documentation to update project teams and stakeholders.
• Stay current with emerging analytical technologies and regulatory trends in RNA characterization.

Qualifications & Experience

• A doctorate degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
• A minimum of +4 (Scientist) or +8 (Senior Scientist) years of hands-on experience in analytical development for nucleic acid therapeutics in pharmaceutical or biotechnology organizations.
• Hands-on experience with multiscale purification methods (e.g., preparative RP-HPLC, affinity, ion-exchange, hydrophobic interaction, and size exclusion chromatography, tangential flow filtration) and the enabling analytical tools/instruments.
• Deep understanding of multiple analytical techniques (e.g., LC-MS, LC-HRMS, CE-SDS, DSC, HIC, NMR) coupled with hands-on experience developing analytical workflows for robust characterization of RNA raw materials, DS, and DP.
• Hands-on experience developing and executing LC-MS workflows to perform in-process and final QC of modified oligonucleotides and ligand-oligo conjugates (e.g., GalNAc, cholesterol, fatty acids) to support multiple pipeline programs.
• Demonstrated experience establishing automated high throughput analytical capabilities to achieve high synthetic throughput.
• Familiarity with regulatory expectations for analytical method validation and CMC documentation in support of IND-enabling studies is strongly desired.
• A dependable contributor to cross-functional teams who embraces a collaborative culture while demonstrating the autonomy and initiative required to deliver on assigned scientific and operational responsibilities.
• Demonstrated ability to troubleshoot complex scientific problems and adapt to shifting priorities in a fast-paced, quality-driven environment.
• Excellent organizational, interpersonal, and verbal/written communication skills.