Senior Research Associate, Formulation and Analytical Characterization

Pivotal•San Diego, CA

2d•Onsite

About The Position

A new stealth-mode biotech focused on in vivo gene editing is seeking a hands-on, lab-based Senior Research Associate with strong analytical characterization expertise. The role centers 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 characterization data to guide formulation decisions and support LNP preparation, optimization, and process troubleshooting. Final title and salary are commensurate with experience. The position collaborates with formulation, downstream process, analytical, and biology teams to align characterization workflows with program timelines. The role is onsite in a San Diego laboratory. Applicants must be eligible to work in the United States for any employer without sponsorship and must apply directly, not through a third-party 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 working with 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 laboratory in San Diego.
Must apply directly and not through a third-party 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, 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 populations, including fluorescence-based labeling strategies for cargo and surface ligand detection.
Execute and support LNP formulation activities using microfluidic mixing platforms, 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, ensuring data integrity and traceability for characterization and formulation activities.
Contribute to 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 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.