Scientist/Senior Scientist, RNA Analytical Development

Position Overview

We seek a highly innovative and results-driven scientific leader with deep expertise spanning multiple RNA modalities to establish the analytical development processes. This role is instrumental in establishing and executing phase-appropriate analytical strategies for raw materials (e.g., novel lipids, targeting ligands, pDNA), drug substances (DS) spanning mRNA and synthetic oligonucleotides (e.g., ASO, siRNA, gRNA), and drug products (DP) (e.g., conjugated oligonucleotides). The successful candidate will establish robust, scalable, and phase-appropriate analytical workflows to support platform scalability and pipeline programs. This role is critical to ensuring quality materials are developed and utilized across NATi’s translational programs.

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.

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.

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