About the role
AI summarisedLead analytical development for RNA therapeutics at Singapore's national RNA platform. Design and validate phase-appropriate analytical workflows for mRNA, ASO, siRNA, and LNP drug products using advanced chromatography, mass spec, and biophysical techniques to support IND-enabling studies.
ResearchOnsite
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
Requirements
- 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
- 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