Analytical Scientist, Ph.D

Analytical Scientist, Ph.D.

Location:

San Diego, CA

Job Type: Full-Time, Onsite

We are an innovative, stealth-mode biotech focused on developing best-in-class delivery for in vivo gene editing.

We are seeking a highly skilled Analytical Scientist to join our team in a hands‑on, lab‑based role. The successful candidate will be responsible for developing, validating, and executing analytical methods for the characterization of proteins, RNA, and lipids, central to our lipid nanoparticle (LNP) gene editing platform. This role requires deep expertise in LC/MS and complementary analytical techniques, with the ability to independently design experiments, troubleshoot complex analytical challenges, and deliver high‑quality data to support research, process development, and regulatory submissions.

The Analytical Scientist will serve as a subject matter expert across the organization on bioanalytical methodologies. Title and salary will be commensurate with experience.

• Design, develop, optimize, and validate analytical methods for the characterization of proteins (e.g., Cas9, antibody constructs), mRNA, gRNA, and lipid components using LC/MS (intact mass, peptide mapping, oligonucleotide analysis, lipidomics).
• Perform routine and non‑routine hands‑on analyses in the laboratory; operate, maintain, and troubleshoot LC/MS instrumentation (e.g., Q‑TOF, Orbitrap, triple quadrupole) and associated sample preparation workflows.
• Develop and execute orthogonal analytical methods including but not limited to HPLC/UPLC (RP, SEC, IEX, HILIC), capillary electrophoresis, UV/Vis spectrophotometry, and fluorescence‑based assays.
• Characterize LNP drug product attributes including lipid composition and ratios, encapsulation efficiency, RNA integrity, protein identity and purity, and post‑translational or chemical modifications.
• Support formulation development, process development, and stability studies by providing timely, high‑quality analytical data and interpretation.
• Author and review analytical methods, protocols, technical reports, and SOPs to support research activities and future regulatory filings.
• Analyze and interpret complex mass spectrometry datasets; present findings to cross‑functional teams and contribute to program‑level decision‑making.
• Evaluate and implement new analytical technologies, software tools, and workflows to improve throughput, sensitivity, and data quality.
• Collaborate closely with formulation scientists, biologists, process development, and CMC teams to ensure analytical needs are met across programs.
• Maintain laboratory equipment, consumable inventories, and ensure compliance with safety and data integrity standards.

• D. in Analytical Chemistry, Biochemistry, Chemistry, Pharmaceutical Sciences, or a related field.
• 3+ years of industry or postdoctoral experience in bioanalytical method development and characterization of biopharmaceuticals, nucleic acids, or lipid‑based drug products.
• Extensive hands‑on experience with LC/MS platforms (Q‑TOF, Orbitrap, or triple quadrupole) for protein, oligonucleotide, and/or lipid analysis.
• Proficiency in chromatographic techniques (RP‑HPLC, SEC, IEX, HILIC) and associated data analysis software (e.g., Mass Lynx, Xcalibur, Empower, Bio Pharma Finder, UNIFI).
• Strong understanding of protein characterization (intact mass, peptide mapping, glycosylation, disulfide mapping) and/or nucleic acid analysis (RNA integrity, modification mapping, sequence confirmation).
• Demonstrated ability to independently design experiments, interpret complex datasets, and communicate results clearly in written and oral formats.
• Strong problem‑solving skills and ability to manage multiple projects in a fast‑paced environment.

• Experience with lipid nanoparticle characterization and/or lipidomics by LC/MS.
• Familiarity with mRNA and guide RNA analytical characterization (e.g., capillary electrophoresis, IP‑RP‑HPLC, LC/MS‑based modification analysis).
• Experience supporting GMP or GLP analytical activities, method validation per ICH guidelines (Q2/Q14), or contributing to regulatory submissions.
• Knowledge of gene therapy or gene…