Senior Research Associate, Formulation and Analytical Characterization

Pivotal•San Diego, CA

3d•$80,000 - $120,000•Onsite

About The Position

A new stealth-mode biotech focused on in vivo gene editing is seeking a motivated Senior Research Associate with strong analytical characterization expertise. This full-time, hands-on, lab-based role focuses on 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 high-quality characterization data to guide formulation decisions and directly support LNP formulation preparation, optimization, and process troubleshooting. The position is suited to a scientist who enjoys bench work and combines rigorous analytical skills with practical formulation experience. Final title and salary are commensurate with experience. The role involves collaborating with formulation, downstream process, analytical, and biology teams to align characterization workflows with program timelines. The successful candidate will also contribute to analytical SOPs, method qualification protocols, and technical reports, while maintaining accurate and traceable laboratory records and ensuring instruments and laboratory supplies are managed appropriately. Applicants must be eligible to work in the United States for any employer without sponsorship, able to work onsite in the San Diego lab, and apply directly rather than through a staffing agency.

Requirements

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.
3–5+ years of hands-on experience in pharmaceutical or biopharmaceutical formulation and/or analytical characterization, focused 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, such as RiboGreen, PicoGreen, or equivalent fluorescence-based methods.
Familiarity with LNP formulation workflows, including microfluidic mixing and basic lipid handling.
Strong data analysis skills, including comfort using instrument software and generating publication-quality figures and reports.
Excellent attention to detail and organizational skills, with the ability to manage multiple concurrent assays and projects.
Strong communication and teamwork abilities, including comfort presenting data to cross-functional teams.
Eligible to work in the United States for any employer without sponsorship.
Able to work onsite in the lab in San Diego.
Must apply directly and not through a third party or staffing agency.

Nice To Haves

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 or 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, including TFF and SEC, and in-process characterization requirements.
Knowledge of mRNA or gene therapy product development.
Experience with DOE-based experimental design and statistical analysis tools such as JMP, Minitab, or GraphPad Prism.

Responsibilities

Perform routine and advanced analytical characterization of LNP formulations, including particle sizing by DLS and NTA, zeta potential measurement, encapsulation efficiency assays such as 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 to detect cargo and surface ligands.
Execute and support LNP formulation activities using microfluidic mixing platforms such as 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; prepare data summaries, trend analyses, and comparison reports for cross-functional review.
Maintain detailed and accurate electronic laboratory notebooks and ensure data integrity and traceability for characterization and formulation activities.
Contribute to developing and documenting analytical SOPs, method qualification protocols, and technical reports.
Manage inventory of characterization reagents, consumables, and standards; ensure instruments are maintained on schedule and operate 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.