Advisor/Senior Advisor Biophysical Characterization

Responsibilities

• Develop, optimize, and execute analytical methods intended for a variety of purposes, including release and stability testing, product characterization, high-throughput analysis, and characterization of complex raw materials.
• Review, interpret, and present data within the analytical team and cross-functionally.
• Provide technical oversight for troubleshooting and phase-appropriate qualification and validation of analytical assays for the analysis of gRNA, mRNA, and LNP.
• Author, review, and revise technical source documents to support phase-appropriate comparability.
• Serve as the CMC representative on cross-functional project teams.
• Provide technical oversight to guide analytical/QC investigations, as needed.
• Actively collaborate with internal and external process development and quality teams.
• Train and mentor junior team members

Basic Requirements

• Hands-on experience developing and troubleshooting analytical methods applied to complex and heterogeneous systems (e.g., HPLC/UPLC, capillary electrophoresis, cryo-TEM, NMR, MALS, DLS, NTA, etc.).
• Previous experience developing methods for gRNA, mRNA, and LNPs.
• Excellent scientific knowledge in analytical chemistry with a conceptual understanding of solid-phase oligonucleotide synthesis and purification strategies.
• Hands-on experience analyzing DNA/RNA using various techniques (e.g., IP-RP, IEX, LC-fluor, multi-modal LC, etc.).
• Advanced understanding of lipid nanoparticle delivery, production, and purification.
• Familiarity with applicable ICH regulations and multi-compendial guidelines related to method validation.
• Experience in assay development, qualification, validation, and implementation to support target candidate validation from non-GxP to GMP environments.

Additional Skills/Preferences

• Proactive, creative, and positive attitude.
• Effective oral and written communication skills.
• Demonstrated scientific and people leadership skills