We are seeking a Senior Scientist II to join our experienced, fast-paced, and collaborative Analytical Development team. The successful candidate will provide scientific and technical leadership for analytical characterization of mRNA-based therapeutics and targeted lipid nanoparticle formulations.
This role will focus on developing and implementing robust analytical methods for pipeline support, with particular emphasis on RNA and lipids characterization, routine assay development, workflow optimization, and laboratory automation. The scientist will work closely with discovery, formulation, process development, and other cross-functional partners to advance product and process understanding, support candidate selection, and expand the analytical capabilities of the mRNA and lipid nanoparticle platform.
Key Responsibilities
- Lead analytical method development and characterization activities for mRNA drug substance and mRNA-based lipid nanoparticle programs, with emphasis on pipeline support and candidate selection.
- Develop, implement, and troubleshoot fit-for-purpose methods for routine and non-routine analysis of RNA, lipids, lipid-related impurities, oligonucleotides, and proteins using techniques such as liquid chromatography with various detection modes (e.g. UV, CAD, MS, MALLS, Fl), capillary electrophoresis, and plate-based assays.
- Design analytical strategies that support product characterization, process understanding, comparability, stability, and method qualification or transfer activities, as needed.
- Establish efficient, reproducible workflows for analytical testing, data processing, and interpretation, and identify opportunities to streamline or automate routine activities.
- Investigate complex analytical problems, evaluate emerging technologies, and introduce new capabilities that address program and platform needs.
- Partner with formulation, discovery, process development, and other cross-functional teams to characterize lipid nanoparticle composition, product quality attributes, and related impurities.
- Contribute to characterization of plasmids and assessment of relationships between plasmid attributes and mRNA product quality, as appropriate.
- Represent Analytical Development on pipeline, technology development, and platform teams, and communicate results, risks, and recommendations clearly to stakeholders.
- Provide scientific guidance and technical mentorship to junior scientists and contribute to analytical best practices within the sub-team.
- Author and review technical reports, analytical procedures, study protocols, and other scientific documentation.