Job Title: Senior Research Associate, Formulation and Analytical Characterization
Location: San Diego
Job Type: Full-Time
Job Summary: We are seeking a motivated Senior Research Associate with strong analytical characterization expertise to join our team. This hands-on, lab-based role centers on the physicochemical characterization of lipid nanoparticle (LNP) formulations using NanoFCM, dynamic light scattering (DLS), nanoparticle tracking analysis (NTA), encapsulation efficiency assays, and other routine and advanced analytical methods. The successful candidate will generate the high-quality characterization data that drives formulation decisions and will also directly support LNP formulation activities, including preparation, optimization, and process troubleshooting. This is an ideal role for a scientist who thrives at the bench, combines rigorous analytical skills with practical formulation experience, and wants to make a direct impact in a fast-moving gene therapy program. Final title and salary commensurate with experience.
Key Responsibilities:
- Perform routine and advanced analytical characterization of LNP formulations, including particle sizing (DLS, NTA), zeta potential measurement, encapsulation efficiency (RiboGreen or equivalent), and particle concentration and phenotyping by NanoFCM.
- Operate, maintain, calibrate, and troubleshoot NanoFCM instrumentation; develop and optimize NanoFCM methods for single-particle analysis of LNP and targeted LNP (tLNP) populations, including fluorescence-based labeling strategies for cargo and surface ligand detection.
- Execute and support LNP formulation activities using microfluidic mixing platforms (e.g., NanoAssemblr), including lipid stock preparation, formulation parameter optimization, and small-scale screening experiments.
- Perform additional characterization assays as needed, including cryo-TEM sample preparation, HPLC-based lipid and RNA quantitation, gel electrophoresis for RNA integrity, and UV/Vis spectrophotometry.
- Analyze, compile, and present characterization data to support formulation development decisions; generate clear data summaries, trend analyses, and comparison reports for cross-functional review.
- Maintain detailed and accurate electronic laboratory notebooks, ensuring data integrity and traceability for all characterization and formulation activities.
- Contribute to the development and documentation of analytical SOPs, method qualification protocols, and technical reports.
- Manage laboratory inventory for characterization reagents, consumables, and standards; ensure instruments are maintained on schedule and operating within specification.
- Collaborate with formulation scientists, downstream process scientists, analytical scientists, and biology teams to align characterization workflows with program timelines.
- Stay current with emerging nanoparticle characterization technologies and methods relevant to LNP drug product development.
Qualifications:
- Bachelor's or Master's degree in Chemistry, Pharmaceutics, Biochemistry, Biomedical Engineering, Chemical Engineering, or a related field. Ph.D. candidates with relevant experience are also encouraged to apply. Title and salary will be commensurate with experience.
- 3-5+ years of hands-on experience in pharmaceutical or biopharmaceutical formulation and/or analytical characterization, with a focus on lipid nanoparticles or related colloidal drug delivery systems.
- Direct experience with nanoparticle sizing and characterization techniques, including DLS, NTA, and NanoFCM or traditional flow cytometry.
- Proficiency in encapsulation efficiency assays (e.g., RiboGreen, PicoGreen, or equivalent fluorescence-based methods).
- Familiarity with LNP formulation workflows, including microfluidic mixing and basic lipid handling.
- Strong data analysis skills; comfortable working with instrument software and generating publication-quality figures and reports.
- Excellent attention to detail, organizational skills, and ability to manage multiple concurrent assays and projects.
- Strong communication and teamwork abilities; comfortable presenting data to cross-functional teams.
Preferred Qualifications:
- Hands-on experience with NanoFCM or traditional flow cytometry, ideally for single-particle analysis of nanoparticles, extracellular vesicles, or similar systems.
- Experience supporting GMP or GLP analytical activities, or familiarity with method qualification/validation in a regulated environment.
- Experience with cryo-TEM sample preparation or interpretation of cryo-TEM images for LNP morphology assessment.
- Familiarity with downstream LNP processing (TFF, SEC) and in-process characterization requirements.
- Knowledge of mRNA or gene therapy product development.
- Experience with DOE-based experimental design and statistical analysis tools (e.g., JMP, Minitab, GraphPad Prism).
Benefits:
- Competitive salary, equity, and benefits package.
- Opportunities for professional growth and development.
- Fast-paced collaborative and innovative work environment.
How to Apply: Interested candidates should submit their resume and a cover letter detailing their relevant experience. To be considered for the role, applicants must be:
- Eligible to work in the United States for any employer without sponsorship.
- Able to work onsite in the lab located in San Diego.
- A direct candidate and not from a third party, i.e. staffing agency.
