Group Leader, Analytical Development – RNA Medicines

Position Overview

We seek a highly innovative and results-driven scientific leader with deep expertise spanning multiple RNA modalities to establish the analytical development group. 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., lipid nanoparticles, conjugated oligonucleotides). The successful candidate will build and lead a small analytical development team, and 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.
• Build and mentor a small team of analytical scientists, overseeing method development, qualification, and documentation.
• 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.
• Contribute to CMC documentation for IND-enabling studies and regulatory submissions.
• Stay current with emerging analytical technologies and regulatory trends in RNA therapeutics and nanoparticle characterization.

Qualifications & Experience

• A doctorate degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• A minimum of +10 (Principal Scientist), +13 (Associate Director) years of experience with analytical development for nucleic acid therapeutics in pharmaceutical or biotechnology organizations; Associate Director candidates are expected to demonstrate strategic leadership, cross-functional influence, and a track record of building analytical capabilities aligned with regulatory and commercial goals.
• Experience building/leading an Analytical Development group spanning equipment selection, setup and qualification, talent recruitment and mentoring, establishing robust workflows, and demonstrating a strong track record of productivity.
• 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.
• 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.

Apply Here: Career – Agency for Science, Technology and Research